COVID-19: Start of Phase 2 clinical trial of IMU-838

Immunic Therapeutics hat von der Deutschen Gesundheitsbehörde (BfArM) die Genehmigung für den Start einer klinischen Phase-2-Studie mit...

COVID-19: Start of Phase 2 clinical trial of IMU-838 - Aenova Group

COVID-19: Start der Klinische Phase-2-Studie von IMU-838 - Aenova Group

Immunic Therapeutics has received approval from the German Federal Institute for Drugs and Medical Devices (BfArM) to initiate a Phase 2 clinical trial with its selective oral DHODH inhibitor IMU-838 for the treatment of COVID-19. We at Aenova Group are pleased to have been able to participate in the development of the drug and to supply the material for the clinical trial.

Starnberg

Aenova statement on the Evolution of the CDMO Industry

07/11/2024 - Aenova statement on the Evolution of the CDMO Industry

Starnberg, 07.11.2024

The current issue of the renowed magazine CHEManager International features a very interesting series of interviews on the topic "The Evolution of the CDMO Industry". More than 25 executives and industry experts give their views on how their companies. Aenova Chief Commercial Officer Neil Jones is among them and shares his view on the CDMO market and highlights three key aspects of an excellent partnership between customer and CDMO partner. Read <a href="https://www.chemanager-online.com/en/news/expert-statement-neil-jones-aenova">more</a>.
The evolution of the CDMO sector is propelled by rising manufacturing standards, the advent of groundbreaking therapies, and a shift towards personalized medicine.
Contract development and manufacturing organizations (CDMOs) have been on the rise in the last decade. Historically, CDMOs operated on a business model which predominantly focused on serving as external service providers for manufacturing pharmaceuticals. This model included the addition of capacity by the acquisition of manufacturing facilities from (bio)pharma companies or own capital investments. However, CDMOs have increasingly become innovation leaders and cover more areas of the pharma business, not just manufacturing, opening up additional revenue streams.
You can find the entire statement series <a href="https://www.chemanager-online.com/en/news/evolution-cdmo-industry">here</a>.

Aenova CEO Awards for outstanding value orientation

25/10/2024 - Aenova CEO Awards for outstanding value orientation

Starnberg, 25/10/2024

At the Aenova Leadership Summit this week, the CEO Awards were presented for outstanding achievements and successes in line with our five core Aenova values. The awards went to employees and their teams who embody our core values in a special way in their daily work.
Aenova is characterized by a strong corporate culture based on five core values. That is why the Aenova CEO Awards were presented for the first time this year, honouring exemplary behavior by employees and teams along these five values:
#1 Customers and patients first #2 Everyone matters #3 Excellence and reliability #4 Better every day #5 Stronger as a group A heartfelt congratulations to all the winners!
The Aenova Leadership Summit focused on best-practice presentations, departmental workshops, and networking within the Aenova Group. The program was complemented by inspiring talks with and from our customers and patients.
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova-CEO-Award_2024.jpg" data-image="567249" alt="CEO Award 2024"><figcaption>The five winners together with Aenova CEO Jan Kengelbach (center)</figcaption></figure>

Aenova strengthens its development services focusing on pre-formulation and bioavailability enhancement

04/10/2024 - Aenova strengthens its development services focusing on pre-formulation and bioavailability enhancement

Starnberg, 04/10/2024

Aenova, one of the world's leading Contract Development and Manufacturing Organizations (CDMO) strengthens its development services, in particular in the areas of formulation and pre-formulation as well as clinical trial services. Thus, Aenova offers its customers an even wider range of end-to-end services in the product life cycle of a drug. The pharmaceutical development market is becoming increasingly complex, with drug discovery and biopharmaceutical companies having a portfolio of molecules that are more difficult than ever to deliver to the human body and to formulate into finished dosage forms. At the same time, with rising R&D costs and increasing pressure to deliver results, pharmaceutical companies must be able to streamline their research processes and optimize their resources. Aenova has responded to these market demands by significantly strengthening its offering in development services in order to support development programs as early as possible, even starting at the pre-clinical phase. As a trusted CDMO, Aenova´s expanded development services provide a science-driven integrated approach from pre-formulation to final formulation at minimum API consumption, as well as analytical method development. A comprehensive technology offering is now available to address the formulation and bioavailability challenges of poorly soluble drugs, including lipid-based formulations, Hot-melt extrusion (HME), spray drying, pelletization with down stream processing in tablets, capsules and low-dosed capsules for all API classes including high-potent APIs. This applies to both NCEs (new chemical entities) and generic reformulations. The range of products and services includes API characterization and formulation services, analytical development, as well as prototyping in fully GMP pilot plants that are integrated in the Aenova manufacturing sites. Aenova has decades of experience in development and offers its customers development services from six Development Centers of Excellence. Highly skilled formulation and analytical scientists bring many years of experience in all phases of the product life cycle. Aenova has also massively invested in the development and fill & finish manufacturing services of injectables in pre-filled syringes and vials. Thus, customers receive all product phases from development to large-scale production from single source and can be supported individually and flexibly according to their needs and regarding various sizes of projects. With this extension of capabilities and a wide range of patient centric dosage forms, Aenova is also targeting new patient populations in need of more patient-friendly medicines, such as children and the elderly. For instance, Aenova has specific platforms for chewable softgels, for the production of nutraceutical or pharmaceutical gummies, for effervescents, and for ODTs (orally disintegrating tablets). These dosage forms are often favored for their ease of administration and can be adapted to consumer health or nutraceutical products but also prescription products. “While CDMOs must continue to support the lifecycle of existing products and technologies, they also need to keep investing in additional capabilities to offer an even broader range of services to help pharmaceutical and biotech companies accelerate their programs and focus their resources where they can add the most value. With its extended range of development services, Aenova is in a position to support its customers in exactly this area”, explains Florent Bordet, Chief Scientific Officer at Aenova.

Regensburg

Aenova scales up high-potent medicines´ development and manufacturing capabilities

16/09/2024 - Aenova scales up high-potent medicines´ development and manufacturing capabilities

Regensburg, 16/09/2024

Aenova, one of the world's leading Contract Development and Manufacturing Organizations (CDMO) expands its offering for the development and manufacturing of high-potent active pharmaceutical ingredients at its Regensburg site. Aenova thus provides its customers with doubled capacities for laboratory and manufacturing and strengthened its development services for innovative APIs including pre-formulation services. Highly effective active pharmaceutical ingredients, e.g. for cancer drugs and immunosuppressants, are increasingly in demand on the global pharmaceutical market. The Aenova site in Regensburg is well prepared for this constantly growing trend. The company has invested a total of around 25 million euros to double its laboratory, development, and production capacities. The new building constructed for this purpose was officially inaugurated just last year. The Aenova site in Regensburg offers a comprehensive range of development and production equipment for production from very small quantities to scale-up for high-volume manufacturing. Up to 200,000 capsules and 500,000 tablets per hour can be produced with maximum efficiency and the highest quality standards using automated IPCs and fully automated visual inspection. Additionally, a dedicated production area for clinical material and niche oncology products allows the supply of smaller batch sizes, which is particularly beneficial for clinical phases. Aenova also offers various packaging solutions, including both bottles and blisters, meeting all global serialization and aggregation requirements. In addition, development services have been expanded, providing a science-driven integrated approach from pre-formulation to final formulation at minimum API consumption, as well as analytical method development. New technologies, such as hot melt extrusion, are used to process poor bioavailability compounds. This applies to both NCEs (new chemical entities) and generic reformulations. Highly skilled formulation and analytical scientists bring many years of experience in all phases of the product life cycle. The Aenova Regensburg site is a Competence Center for the development and production of oral solid dosage forms containing high-potency APIs. The site supplies customers in all the relevant pharmaceutical markets around the world with life-saving products. Customers receive all product phases from development to large-scale production and can be supported individually and flexibly according to their needs. "With our own GMP production and laboratory area, we not only achieve a significant increase in production volumes, but also meet all our customers' requirements for highly potent solids from a single source. This is our unique selling point," comments Oliver Schmied, Managing Director of Aenova's Regensburg site.

<figure><img src="https://www.aenova-group.com/content/_medium/20240409_Aenova_Regensburg16762.jpg" data-image="566796" alt="High containment Regensburg"><figcaption>Flexible high-containment manufacturing solutions for high-potent APIs (Photo: Aenova)</figcaption></figure>
<figure><img src="https://www.aenova-group.com/content/_medium/20240409_Aenova_Regensburg15873.jpg" data-image="566793" alt="Packaging Line Regensburg"><figcaption>Flexible manufacturing and packaging solutions for high-potent APIs (Photo: Aenova)</figcaption></figure>

Closing completed: Kühne Holding is new majority shareholder of pharma contract manufacturer Aenova

30/08/2024 - Closing completed: Kühne Holding is new majority shareholder of pharma contract manufacturer Aenova

Starnberg, 30/08/2024

After a successful regulatory approvals process, the takeover of the pharma contract development and manufacturing organization Aenova by Kühne Holding AG was closed on August 29, 2024. The previous owner, the private investment company BC Partners, will support Aenova alongside Kühne Holding AG as a minority shareholder.
Aenova is one of the world's leading CDMOs (Contract Development and Manufacturing Organizations) in the pharmaceutical and healthcare industry. Headquartered in Starnberg near Munich and with around 4,000 employees at 14 production sites worldwide, the company is a full-service provider for the development, manufacturing, and packaging of drug products for pharma companies around the globe. At the end of April 2024, it was announced that Kühne Holding AG has entered into a definitive agreement to acquire Aenova from leading international investment firm BC Partners. The regulatory approvals process has been conducted over the past few months. The closing took place on August 29, 2024. "With Kühne Holding AG, we have a strong partner for the further implementation of our strategy to make Aenova the leading CDMO with flexible capacities and innovative specialty platforms. We will continue to strengthen our competitive advantage in the production of conventional dosage forms while expanding in-demand technology platforms and development services to meet the future needs of our customers and thus provide patients worldwide with our services," explains Jan Kengelbach, who has led Aenova as CEO since 2018.

Cornu

Aenova expands with new gummy line for pharma and food grade

28/08/2024 - Aenova expands with new gummy line for pharma and food grade

Starnberg, 28/08/2024

Aenova, one of the world's leading CDMOs (Contract Development and Manufacturing Organizations) for the pharmaceutical and healthcare industries, is implementing a new gummy line at its site in Cornu, Romania. Gummies are quickly emerging as the dosage form of choice for many food supplements and even pharmaceutical applications. The new gummy line will be launched by the end of 2024 with a capacity of approximately 1 billion gummies per year. The global gummy supplements market has reached a value of over $ 9 billion in 2023 and is expected to grow to $ 18.2 billion by 2033. The surge in demand for gummies (chewable gels) is driven by a number of benefits related to convenience, indulgence, and efficacy. Aenova's new gummy line addresses this market with a complete, state-of-the-art production area for gummies, including bottle packaging, which has been developed with an investment of approximately € 8 million. The manufacturing process is starchless and offers food and pharmaceutical grade (GMP) production for gelatin and pectin formulations with halal, kosher, and vegan options available. Format settings can be tailored to suit a range of sizes and shapes. The new line, with a capacity of approximately one billion gummies per year, is scheduled to go live at the end of 2024. While gummies are helpful for children and anyone who has difficulty swallowing or digesting medications, adults enjoy them as well. Specialized gummy formulas can address specific needs such as immune system support, bone health, digestive issues, pain, sleep, or antioxidants. Gummies release their active ingredients when they are chewed and their flavor can mask unpleasant tastes and odors, providing a much more enjoyable experience than traditional pills. With formulas that are free of artificial colors, flavors or even sugar, they also offer vegan-friendly options that use pectin as a base, giving consumers a health-conscious choice. “Our new gummy area offers our customers a brand-new platform that will facilitate our entry into an attractive market and allow our company to gain a competitive edge in terms of experience, flexibility, and market presence. With over 40 years of experience in gelatin cooking and handling, Aenova offers excellent standards of hygiene, efficiency, and product quality”, comments Michael Ammann, Managing Director Site Cornu / Vice President Operations Softgel Capsules at the Aenova Group.

Latina

Aenova expert article on "Optimising the pre-filled syringe filling process"

31/07/2024 - Aenova expert article on "Optimising the pre-filled syringe filling process"

Latina, 31/07/2024

In recent years, the market demand for user-friendly injectable delivery systems has increased. 
The development of Prefilled Syringes (PFS) has piqued substantial interest in the industry, primarily due to its unique advantages. PFS, designed for self-administration, offers rapid injection efficiency and unparalleled dosing accuracy, making it a game changer in the field of injectable delivery systems. Among the currently available fill-and-finish technologies, peristaltic pump dosing and single-use filling assemblies have attracted attention as clean technologies that allow gentle product transfer and minimize shear stress on formulation. For this study, conducted at the Aenova Group’s Latina site in collaboration with the Pharmacy Department of “G. D’Annunzio” University (Chieti-Pescara), a custom-designed, single-use filling assembly made of ePTFE and silicon was utilized. This innovative assembly, chosen to minimize operator handling and connection in an aseptic environment, is high-temperature resistant, can be cleaned in place (CIP) and sterilized in place (SIP) and is resistant to mechanical stress with minimal spallation phenomenon. These features significantly contribute to its practicality and effectiveness in PFS manufacturing. The quality of the filling profile is critical to ensure dosing accuracy. Therefore, the study’s scope was to understand the influence of the filling line parameters and the geometry of the filling assembly on the filling profile and dosing accuracy. A design of experiments approach was applied, and a capability analysis was performed to evaluate statistical process control. An optimal combination of the best possible filling profile and filling speed sustainable for business purposes was identified, providing valuable insight into the challenges of PFS manufacturing. The results obtained by Aenova, set a benchmark for fill-and-finish manufacturing processes. They show that the configuration and type of materials identified can be a viable alternative for the production of biological injectables whose active ingredients are susceptible to gamma radiated materials or exposure to high levels of hydrogen peroxides. This finding ensures filling stability for extended production runs, providing crucial information for the industry. Aenova is a global leading Contract Development and Manufacturing Organization with a Competence Center for sterile technologies at its site in Latina, Italy.
The study on the topic "Optimizing the Prefilled Syringe Filling Process for Biological Molecules Using Innovative Single-Use Technologies: A Design of Experiments Approach" is published in the current issue of the renowned magazine “Pharmaceutical Manufacturing and Packaging Sourcer – Parenteral Technology Supplement 2024”.
With credits to: Pharmaceutical Manufacturing and Packing Sourcer, Parenteral Technology Supplement 2024, pages 37-41. © Samedan Ltd.
<a href="https://www.aenova-group.com/content/Aenova_Fill-and-Finish-study-on-optimized-filling-process_Parenteral-Tech-Supp-2024.pdf">Aenova Fill and Finish study on optimized filling process Parenteral Tech Supp 2024</a> 
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_Latina_PFS.jpg" data-image="565951" alt="Aenova Latina PFS"><figcaption>Manufacturing of pre-filled syringes at the Aenova Latina site</figcaption></figure>

Aenova published Annual Report 2023: Best financial year in the company's history

05/07/2024 - Aenova published Annual Report 2023: Best financial year in the company's history

Starnberg, 05/07/2024

Starnberg, 08 July 2024 - The Aenova Group has published its annual report for 2023, which reflects the most successful business year in the history of the Aenova Group. The financial results are very strong, as the key figures for 2023 showcases at a glance:<ul><li>EUR 137 million adj. EBITDA</li><li>EUR 166 million new business wins</li><li>EUR 833 million revenue (pro forma)</li></ul>
For Aenova, the year 2023 was a record year in many respects. Revenue grew by 17% to EUR 833 m and EBITDA surged to a record level of EUR 137 m. New wins rose by 95% to EUR 166 m compared to previous year. Major new wins include originator products and a high-volume GLP-1 receptor agonist, demonstrating Aenova's strategic focus on innovative and high-potential drugs. The strategy of expanding capacities and upgrading the machine park in the established products’ business, while building differentiated technology platforms and commercializing the development projects of first-to-market generics as well as NCEs has outperformed the expectations. The outlook for the current year and the coming years is also extremely promising. With the specific focus on expanding existing technology platforms, plus the launch of new platforms, including organic spray drying, large molecule fill and finish, hot melt extrusion, low-dose capsule filling and the launch of a large-volume OTC and nutraceutical gummy platform, Aenova is positioned very well for further growth in 2024 and beyond. The Aenova Annual Report 2023 is available <a href="https://www.aenova-group.com/content/Aenova_Annual_Report_2023.pdf">here</a>.

Kirchberg

New Aenova White Paper: Softgel Capsules. A solution for poorly soluble and low bioavailability APIs

28/06/2024 - New Aenova White Paper: Softgel Capsules. A solution for poorly soluble and low bioavailability APIs

Starnberg, 28/06/2024

Low aqueous drug solubility in pharmaceutical development is a recurring issue. The softgel capsule offers many possibilities in the development of new drugs, especially when it comes to solubility and bioavailability enhancement. In the current white paper, experts from Aenova explain the challenges of softgel capsules in development and commercial production, particularly considering the complexity of softgel production technology, as well as the suitability of the softgel capsule as an appropriate dosage form for certain areas of application.
Explore the transformative potential of softgel capsule technology with the new Aenova white paper. This white paper delves into the intricacies of developing and producing softgel capsules, highlighting the advantages they provide in drug formulation, including improved stability, patient-friendly administration, and precise dosing. With insights from Aenova’s decades of expertise, learn how an experienced CDMO can be a valuable partner in unlocking alternative forms of drug delivery and driving the success of your pharmaceutical products.
Get in touch with our <a href="mailto:contact-sales@aenova-group.com?subject=New Aenova white paper Softgel Capsules" target="_blank">sales team</a> right away.
Learn more in our <a href="https://www.aenova-group.com/content/Aenova_Whitepaper_Pharmaceutical_Softgel_Capsules.pdf">white paper "Softgel Capsules. A solution for poorly soluble and low bioavailability APIs".</a>

Aenova achieves silver medal in EcoVadis sustainability rating

07/06/2024 - Aenova achieves silver medal in EcoVadis sustainability rating

Starnberg, 07/06/2024

Aenova has once again achieved silver status in the latest EcoVadis sustainability rating. The rating documents the sustainability status of the Aenova Group in the categories "Environment", "Labor and Human Rights", "Ethics" and "Sustainable Procurement". The result places Aenova in the top 15% of companies assessed by EcoVadis. Certified proof of sustainability in the areas of environment, labor, ethics and procurement is becoming increasingly important for companies and their suppliers. Approximately half of the world's leading pharmaceutical companies use the assessment of EcoVadis, one of the largest international providers of sustainability ratings, for this purpose. The Aenova Group also undergoes an annual assessment by EcoVadis. Aenova achieved significantly improved results in the area of ethics compared to the previous year. The introduction of a whistleblower system and an incident response procedure led to an increase in the rating. In the area of procurement, Aenova was able to score significantly by introducing monitoring and reporting on the Supply Chain Due Diligence Act (LkSG) for suppliers. This ensures that suppliers in Aenova's supply chain are LkSG compliant according to the current legal situation. Significant improvements have also been achieved through the implementation of the Aenova Supplier Code of Conduct and the integration of social/environmental clauses in supplier contracts. The responsible use of resources is also recognized, as the production steps in the pharmaceutical industry are energy intensive. Many Aenova sites already have photovoltaic systems to generate their own electricity. Other sites are being equipped with photovoltaic systems on an ongoing basis. The silver medal places Aenova in the top 15 percent of companies rated by EcoVadis. Approximately 130,000 companies worldwide use the EcoVadis sustainability rating. "We are very pleased with the improvement of our results in the latest EcoVadis assessment and see this as an incentive to further optimize our sustainability strategy. For example, several Aenova sites now use only renewable energy", comments Guy Ridsdill, Global Head of HSE at the Aenova Group.

Kühne Holding acquires Pharma Contract Manufacturer Aenova from BC Partners

24/04/2024 - Kühne Holding acquires Pharma Contract Manufacturer Aenova from BC Partners

Starnberg, 24/04/2024

Kühne Holding AG has entered into a definitive agreement to acquire pharma contract development and manufacturing organization Aenova Group from leading international investment firm BC Partners. As part of the transaction, BC Partners’ advised funds will reinvest alongside Kühne Holding AG and continue to support Aenova as a minority shareholder. Financial terms were not disclosed. The Aenova Group is one of the world's leading CDMOs (Contract Development and Manufacturing Organizations) in the pharmaceutical and healthcare industry. Headquartered in Starnberg, near Munich, and with approximately 4,000 employees in 14 manufacturing sites worldwide, the company is a one-stop service provider for the development, manufacturing, and packaging of drug products for pharma companies around the globe. Under the ownership of BC Partners, the Aenova Group has developed into one of the ten largest CDMOs in the world. The company’s growth trajectory has accelerated under the leadership of CEO Jan Kengelbach, who has repositioned the company into differentiated and innovative growth platforms during his six-year tenure at the helm of the Group. In 2023 Aenova has delivered record results with pro-forma revenue of €832m, an increase of 17% on prior year. The Kühne Holding AG, based in Schindellegi (Switzerland), combines Klaus-Michael Kühne’s business interests. With an entrepreneurial focus, it holds a majority stake in Kühne+Nagel International AG and is the largest single shareholder of Hapag-Lloyd AG, Deutsche Lufthansa AG and Brenntag SE. Dominik de Daniel, CEO at Kühne Holding AG, says: "With this investment, we are taking an important strategic step to enlarge our investment portfolio to include healthcare and pharmaceutical assets with a strong financial base and long-term growth prospects. Aenova is on a great performance track, and we are excited to accelerate it even further under our ownership." BC Partners’ Chairman, Raymond Svider, adds: “It has been a pleasure to partner with Jan and the entire Aenova team on this journey. Together, we have positioned the business as a global leader in contract manufacturing and built solid foundations for future growth, with the company now benefiting from strong sales momentum, a record order book, and supportive sector tailwinds. We’re pleased to see such an important German healthcare business continue its growth trajectory under the strategic ownership of Kühne Holding AG. As a firm, we have a long and successful history of partnering with families and founders across Europe, and we look forward to working closely with Kühne Holding AG and Aenova in this next chapter for the business.” Jan Kengelbach, CEO at Aenova, emphasizes: "With the new ownership structure, we will continue to implement our strategy of making Aenova the go-to CDMO with market-leading capabilities and innovative specialty technologies in Europe. With its long-term investment horizon, Kühne Holding AG is a perfect fit for the business to support this strategy. It allows us to continue down the path of operational excellence in the conventional manufacturing business, while building highly sought-after technology platforms and development services to satisfy the customer demand of the future". E3X Partners (“E3X”), in close partnership with Kühne Holding AG, drove the structuring and execution of the proposed acquisition. Martin Mix, Managing Partner at E3X, an investment and advisory firm, comments: “Our partnership with Kühne Holding AG underscores our strategic commitment to bringing together the right long-term partners for driving growth at Aenova.” Jan-Felix Stolz, Managing Partner at E3X, adds: “Aenova has high strategic relevance for a growing European pharma market, and we are enthusiastic about its prospects.” BC Partners and Aenova have been advised by Jefferies, Kirkland & Ellis, L.E.K. and PwC. Kühne Holding AG and E3X Partners have been advised by Allen & Overy and EY. The transaction is subject to customary closing conditions and approvals of the competent merger control authorities.

Anne-Sophie Bonte appointed as new Chief Quality Officer at Aenova

18/04/2024 - Anne-Sophie Bonte appointed as new Chief Quality Officer at Aenova

Starnberg, 18/04/2024

Dr Anne-Sophie Bonte has been appointed as the new Chief Quality Officer (CQO) at contract developer and manufacturer Aenova, with effect from March 01, 2024. She is also a member of the Executive Leadership Team at Aenova. In her role at Aenova, Anne-Sophie Bonte is responsible for the overall leadership, alignment and execution of the quality manufacturing programs, project management and quality processes across Aenova's production sites and corporate. "I am delighted to shape the further development of Aenova and set the strategic direction to enhance quality-manufacturing strategies, and effectively manage the associated activities and resources necessary to support and harmonize the organization’s quality aspects and business needs," comments Anne-Sophie Bonte on her start at CDMO Aenova. Anne-Sophie Bonte has many years of extensive experience in quality management in the pharmaceutical industry and the CDMO environment. She gains experience in several companies like LFB, Roche and Cenexi before moving into high-level management positions at Catalent and Galderma. She holds a PhD in Pharmacy and a Master's degree in Biological and Medical Sciences from the University of Lille as well as an MSc in Pharmaceutical Development and Industrial Production of Health Products from the Industrial Institute of Pharmacy in Bordeaux. "With Anne-Sophie Bonte, we have found an excellent Chief Quality Officer to continuously improve quality processes and thus further expand the Aenova quality structure in accordance with regulations and customer requirements," says Aenova CEO Jan Kengelbach.

Aenova wins 'Highest Innovative Strength' award

05/04/2024 - Aenova wins 'Highest Innovative Strength' award

Starnberg, 05/04/2024

Aenova has achieved the best result in the generics sector in a study on the innovative strength of German companies, making it the number one company in Germany. The study was conducted by the renowned German newspaper Die WELT in cooperation with the Cologne-based analysis institute ServiceValue. In the online survey, more than 200,000 managers were asked about the innovative strength of 2,350 German companies from various sectors. The survey focused on the company- or market-related innovative strength of the strategies and concepts of the companies assessed, as well as the impetus that the respective company gives to the market. Aenova was awarded "Highest Innovative Strength" in the pharmaceuticals/generics sector, taking first place in Germany ahead of large, well-known competitors in the generics market. Aenova's strategy is increasingly focused on innovation, for example in the development of special technologies and development offerings for generics as well as for patent-protected drugs. Even in the generics sector, drugs that are no longer protected by patents can be innovatively developed further, for example to improve patient convenience with a modified dosage form. One example is the reformulation of a tablet into an orodispersible tablet (ODT), which simply dissolves in the mouth - a growth market that is becoming increasingly important in view of the aging population. At the same time, Aenova continues to invest heavily in highly efficient and semi-automated production capacity for high-volume generics in order to reliably meet the demands of the market. However, Aenova is also expanding its range of differentiated technologies beyond the generics portfolio. In the area of special technologies for new drugs, the company is focusing on the expansion of innovative platforms for improving the bioavailability of active ingredients (e.g. hot melt extrusion, spray drying, softgel capsules), micro-dosed capsules, fill & finish of injectable drugs, high potency drugs, particularly in the field of oncology, and blockbuster products. With its broad range of services, Aenova offers its customers the added value of end-to-end services from development to commercial production for all common dosage forms and thus plays a key role in the global supply of medicines. "The award for "Highest Innovative Strength" honors our strategy of sophisticated development services and innovative special technologies combined with outstanding production capacities. Our goal is to provide our customers, and thus patients worldwide, with their medicines reliably and in the highest quality," explains Jan Kengelbach, CEO of Aenova. "This applies to both high-volume generics and originator products, such as diabetes and cancer medicines. Aenova is characterized by a broad, innovative product range that can respond flexibly to increased market demand. Here you can find out more about the overall results of the study and the study design (in German) <a href="https://servicevalue.de/rankings/generika-10/">https://servicevalue.de/rankings/generika-10/</a><a href="https://servicevalue.de/rankings/generika-10/"></a>
<figure><img src="https://www.aenova-group.com/content/Siegel_Innovationskraft_2024_HÖCHSTE_Aenova.jpg" data-image="562002" alt="Siegel Höchste Innovationskraft"><figcaption>Among German pharmaceutical/generics companies, Aenova was recognized as having the highest innovative strength.</figcaption></figure>

Aenova supports Heimstätten Wil foundation with a donation of 2,000.00 euros

04/04/2024 - Aenova supports Heimstätten Wil foundation with a donation of 2,000.00 euros

Kirchberg, 04/04/2024

Aenova presented the Heimstätten Wil Foundation with a cheque for 2,000.00 euros on April 3, 2024. The idea for the donation campaign was born at the Aenova Corporate Sales Meeting, which took place at the Aenova site in Kirchberg (SG), Switzerland, in February. The company already has a long-standing partnership with the Heimstätten Wil foundation. The Heimstätten Wil Foundation offers living and working spaces for around 400 adults with disabilities. The services are geared towards their individual needs and requirements. External jobs are also offered in cooperation with companies in the primary labor market. Around 160 specialists, apprentices and interns work at the foundation. The Aenova site in Kirchberg has been working with the Heimstätten Wil foundation since the pandemic. Back then, the pharmaceutical company commissioned the foundation to assemble Christmas hampers for its employees. Aenova develops, produces and packages soft gelatine capsules in Kirchberg for the pharmaceutical and healthcare industry, helping patients all over the world to lead healthier lives. More than two billion capsules leave the factory every year and are sold in over 100 countries worldwide, including Europe, the USA and China. The site also fills softgel capsules with highly effective active ingredients in extremely low dosages, where the proverbial Swiss precision is required. Around 170 employees contribute to the success of the company in Kirchberg. "I am very pleased with the decision to donate to an organization in our immediate neighbourhood. We would like to make a contribution to the valuable work of the Heimstätten Wil Foundation," explains Dr. Christian Luftensteiner, Managing Director at the Aenova site in Kirchberg. "Thank you to the Aenova Corporate Sales employees for their generous donation! Every bit of support helps us to get closer to our vision of an inclusive society," says Arlette A. Hippmann, Head of Communications, Heimstätten Wil Foundation.
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_Stiftung-Heimstaetten-Wil-Scheckuebergabe_11.JPG" data-image="561988" alt="Scheckübergabe Wil"><figcaption>Presentation of the Aenova donation check to the Heimstätten Wil Foundation. From left to right: Dr. Christian Luftensteiner, Managing Director of SWISS CAPS AG, Arlette Hippmann, Head of Communications at the Heimstätten Wil Foundation, Thomas Kleeberg, Vice President Business Management, Aenova (Photo: Daniel Müller, employee of the development workshop, Heimstätten Wil Foundation)</figcaption></figure>

OSD outsourcing: challenges and approaches to solutions (article "Contract Pharma")

15/03/2024 - OSD outsourcing: challenges and approaches to solutions ("Contract Pharma" article)

Starnberg, 15/03/2024

The challenges of the current OSD outsourcing market are explained in an excellent editorial overview article in the current issue of the specialist magazine "Contract Pharma".
The article deals not only with contract manufacturing of complex new active pharmaceutical ingredients, but also with aspects of production capacity.
Aenova Chief Commercial Officer Neil Jones and Aenova Chief Scientific Officer Florent Bordet, among others, provide information on current market trends, challenges such as the bioavailability of active ingredients and explain possible solutions. 
Just recently, Aenova reported on major investments for capacity expansions at the high-volume site for conventional solids at the Tittmoning site and emphasized its capabilities in the area of innovative technologies and solutions.
Read more in the current issue of <a href="https://www.contractpharma.com/issues/2024-03-01/view_features/osd-outsourcing-savvy-cmos-hone-skills-as-complex-apis-fuel-demand/?widget=listSection" target="_blank">"Contract Pharma" magazine.</a>
Learn more about the<a href="https://www.aenova-group.com/en/news-events/news/05-12-2023-huge-capacity-increase-at-tittmoning-site"> capacity expansions at the high-volume site for conventional solids </a>at the Tittmoning site and highlighted Aenova's <a href="https://www.aenova-group.com/en/news-events/news/15-09-2023-innovation-is-key-how-cdmos-can-contribute-to-pharma-supply-even-better">capabilities in the area of innovative technologies </a>and solutions.
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_Tittmoning_Expansion_kl.jpg" data-image="560308" alt="Tittmoning Contract Pharma"><figcaption>State-of-the-art, high-volume solids production at the Aenova site in Tittmoning (Photo: Aenova)</figcaption></figure>

New white paper from Aenova: "Faster time to market for pharmaceuticals using capsule low-dosing technology"

29/02/2024 - New white paper from Aenova: "Faster time to market for pharmaceuticals using capsule low-dosing technology"

Starnberg, 29/02/2024

One of the biggest challenges in pharmaceutical research and development is to complete development projects as quickly as possible. More and more drugs fall into the category of 'unmet medical need' and therefore qualify for accelerated approval. But developers need time to optimise the formulation of the sensitive or highly potent compounds that dominate the current pipeline of drug candidates. Finding the right balance between speed and thoroughness is a challenge. But it can be solved by choosing microdosing technology in capsules. Manufacturers can dose small amounts of pure active pharmaceutical ingredients (APIs) or mixtures directly into hard capsules. Microdosing of less than 5 mg or low doses of 5 mg to 100 mg in hard capsules is a good option that allows manufacturers to get new drugs into research and development or onto the market faster. The direct, precise and reliable filling of low-dose hard capsules can be scaled up in an industrial process. This means that processes developed for initial studies can be used for commercial production, eliminating some study and development work and bringing a drug to market faster. Learn more about low-dose capsule technology in Aenova's white paper "Accelerating drug product launches using low-dose capsule technology" in collaboration with the renowned expert platform c&en of the American Chemical Society (ACS). The Aenova sales team will be happy to advise you if you have any questions. Please contact us <a href="mailto:contact-sales@aenova-group.com?subject=Request regarding low-dosed capsule technology" target="_blank">here</a>.
You can download the white paper directly here: <a href="https://www.aenova-group.com/content/resources/Aenova_cen_Whitepaper_Accelerating-pharmaceuticals-time-to-market-applications-of-capsule-low-dosing-technology.pdf">Aenova c&en Whitepaper Accelerating pharmaceuticals´ time to market: applications of capsule low-dosing technology</a>
<figure><img src="https://www.aenova-group.com/content/_medium/3-Kapseln.jpg" data-image="561549" alt="Low-dosed Hartkapseln"><figcaption>Standard hard-shell capsules can be precisely filled with low- or microdoses of an active pharmaceutical ingredient (Photo: Aenova)</figcaption></figure>

Aenova Christmas campaigns: Employees donate to social organisations

18/01/2024 - Aenova Christmas campaigns: Employees donate to social organisations

Starnberg and Tittmoning, 18/01/2024

Once again this year, Aenova organized an internal fundraiser to benefit socially disadvantaged people. Aenova employees at the Aenova headquarters in Starnberg donated winter clothing and winter shoes to a local social institution in December 2023. Many charitable organizations are reporting a decline in donations. This affects disadvantaged and socially disadvantaged people in particular. This makes it all the more important for a charitable organization to be a reliable donation partner. "It is a central concern of ours to support people in need and the socially disadvantaged. A big thank you to our employees who made this joint campaign possible again this year," explains Dr. Susanne Knabe, Head of Corporate Communication at Aenova. The donations in kind were handed over to the facility on January 16, 2024.
At the 2023 summer party at the Aenova site in Tittmoning, there was a raffle with the aim of donating the proceeds to social causes. Apprentices at the site organized the raffle and a large number of employees took part in buying raffle tickets. In December 2023, the donation was handed over to the association "Mia fia Eich e.V" ("We for you"), which supports various social organizations in the south-east of Bavaria. "We can't make the world a better place, but we can make our environment a better world". Under this motto, the association Mia fia Eich e.V., based in Traunstein, has set itself the goal of making a positive and active contribution to daily coexistence through many small good deeds. The Aenova site in Tittmoning regularly supports the "Mia fia Eich e.V." association. As part of its corporate social responsibility strategy, the Aenova Group with its 15 locations worldwide is primarily involved in the local environment and supports charitable initiatives at the individual production sites and at headquarters.<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_Christmas-Charity_2023_double.jpg" data-image="560489" alt="Aenova Charity"><figcaption>left: The treasurer of the association "Mia fia Eich e.V" ("We for you") and the youth trainee representative of Aenova Tittmoning at the donation check handover; right: Tim Bauer, Chief People Officer, and Dr Susanne Knabe, Head of Corporate Communication, before transferring the donations to the recipient organization </figcaption></figure>

Tittmoning

Capacity increases for around 20 million euros: Aenova further expands its high-volume solids site in Tittmoning

05/12/2023 -Capacity increases for around 20 million euros: Aenova further expands its high-volume solids site in Tittmoning

Tittmoning, 04/12/2023

The Aenova Group is one of the world's leading contract manufacturers and development service providers for the pharmaceutical and healthcare industry. Within the Aenova Group, the Tittmoning site is the largest plant for solid oral dosage forms with a capacity of around 10 billion tablets and capsules per year. Due to consistently high demand, Aenova is continuing to invest in this site. In the coming months, four high-speed packaging lines will be installed there at a cost of around EUR 10 million, as well as an additional bulk production line for large-volume preparations with a further investment of EUR 10 million. The market demand for conventional oral solids - tablets, film-coated tablets and hard capsules - is constantly increasing. For this reason, extensive expansion projects have already been realised at the Aenova site in Tittmoning in recent years. A new production building with a total area of 3,100 square meters was put into operation in 2022. The investments made, including new bulk and packaging lines, amounted to a total of around EUR 35 million and aimed to increase capacity by 2 to 3 billion packaged tablets in the final expansion stage. In this context, the new investment projects amounting to around EUR 20 million will increase packaging capacity by around 100 million to a total of 400 million blisters and bulk capacity by almost 1 billion tablets per year. "The additional systems in the bulk production area follow the proven principle of semi-continuous production and the new high-performance packaging lines have fully automated end-of-line packaging. The higher degree of automation not only brings economic benefits, but also supports our product and service quality. At the same time, the investments will create around 50 new, state-of-the-art jobs in the region," explains Dr Helmut Stibich, Managing Director at the Tittmoning site. The first high-speed packaging line will go into operation at the end of 2023, with an almost identical line expected to go into operation in the third quarter of 2024; two further lines will be installed by the first quarter of 2025. A new, fourth production line for large-volume bulk products is to be added by the end of 2024. "With these investments, Aenova is consistently continuing its growth course and consolidating its leading position among the production facilities for conventional solids in Europe at the Tittmoning site. This is an important step towards offering our customers delivery times in line with the market and ensuring patient care," comments Jan Kengelbach, CEO of the Aenova Group.
<figure><img src="https://www.aenova-group.com/content/company/sites/tittmoning/_medium/High_volume_bulk_manufacturing_line_Tittmoning_Aenova.jpg" data-image="559052" alt="Ausbau Tittmoning"><figcaption>Further capacity increases at the Solida site in Tittmoning</figcaption></figure>

Joint Audit Initiative Annual Meeting 2023

24/11/2023 - Joint Audit Initiative Annual Meeting 2023

Starnberg, 24/11/2023

This year, the annual meeting of the JAV (Joint Audit Initiative) was held in Iserlohn, North Rhein-Westphalia, from 24 to 25 October 2023. The "Joint Audit Initiative - JAV" is an organization, with the purpose to provide the partners with audit reports on supplier qualification. A few years ago, some of the leading pharmaceutical companies in Germany made the decision to perform joint supplier audits. Also the Aenova Group is member of the joint initiative. Different companies from pharmaceutical environment, no matter if partners or competitors, big players, or smaller companies, are participating with mutual respect and understanding in a cooperative and expert-wise auditing collaboration. This activity is reducing time, personnel effort, and budget for both: auditors and supplier of materials. All these companies are united through a common GMP practice and development. Each company brings in the auditing process their local auditors which are locally certified under own policies following the same principles of the QMS (Quality Management System). On the top of that, JAV itself underlines a set of rules to be followed internally by its members so the actual implementation of this joint initiative is guided in a centralized way. The JAV Annual General Meeting brings all member companies together once a year to discuss current topics and promote mutual exchange. The Aenova Group was represented by Mirela Pop, Corporate Quality Manager. At Aenova, membership of the Joint Audit Initiative also stands for high quality standards, commitment to customer excellence and outstanding supplier management.A different member company hosts the annual meeting each year. In 2019, the annual meeting took place at the headquarters of the Aenova Group in Starnberg near Munich. Good interactions, successful collaboration and innovative solutions - that is what characterises these meetings, as well as other successful audits.
<figure><img src="https://www.aenova-group.com/content/_medium/JAV-2023.jpg" data-image="560088" alt="JAV 2023"><figcaption>Aenova ambassador Mirela Pop, Corporate Quality Manager, at JAV 2023.</figcaption></figure>

National Future Day in Kirchberg SG

16/11/2023 - National Future Day at Kirchberg SG site

Kirchberg, 16/11/2023

This year's National Future Day took place in Switzerland on November 9. 12 girls and boys left the classroom and immersed themselves in the world of work at our Kirchberg SG site for a day. A change of scene that turned into a big "working day" for our young guests. The schoolchildren were given many insights into a wide variety of professions at our Kirchberg site: in the laboratory, the workshop, production, the high-bay warehouse and the offices. Under expert guidance, they were able to carry out their own color experiments in the laboratory, "cook" gelatine in the large production kitchen and process it with rubber gloves, weld little men and name tags in the workshop and climb onto a large forklift truck in the high-bay warehouse - all this and much more was offered to the children on Future Day. Around 2,500 companies, organizations, vocational schools and universities gave interested schoolchildren an insight into gender-atypical fields of work on Future Day 2023. This allows girls and boys to look at their professional future without rigid gender stereotypes.The Aenova site in Kirchberg is a competence center for the development and production of soft gelatine capsules.
<figure><img src="https://www.aenova-group.com/content/_medium/Nat_Zukunftstag_KIR_2023.jpg" data-image="560048" alt="Nationaler Zukunftstag Kirchberg 2023"><figcaption>Pupils learn about professions regardless of gender on National Future Day</figcaption></figure>

The central role of contract manufacturers in pharmaceutical supply

31/10/2023 - The central role of contract manufacturers in pharmaceutical supply

Starnberg, 31/10/2023

<h5>How CDMOs help ensure the supply of medicines</h5>
Contract manufacturers have a pivotal role in drug supply worldwide, and the trend toward outsourcing continues unabated. Reasons for this include expiring patents on small molecule drugs, the increasing number of small molecules in clinical trials, the rise in chronic and age-related diseases, and the rapidly growing oncology market. At Aenova Group, one of the world's leading CDMOs (Contract Development and Manufacturing Organization) with around 4,000 employees worldwide, there is a significant increase in demand across all dosage forms and therapeutic areas, partly due to post-corona conditions. In this context, it is challenging to install all the necessary capacities, machines and staff, in a timely manner, as equipment manufacturers have long lead times and additional staff often have to be found.
Aenova is driving a growth strategy with massive investments for each site, either to expand existing capacity or to expand the range of innovative technologies. In total, there are 14 new growth platforms at Aenova, eight of which are already commercially active.
<h5>Capacity expansions to meet increased demand</h5>
A few examples illustrate this strategy: the Aenova high-volume site in Tittmoning, Germany, has been expanded to a production capacity of ten billion tablets per year, and four new blister lines with significantly increased capacity will start there by the end of 2025. At the Latina site in Italy, a brand new sterile filling and finishing area (incl. biologics) for prefilled syringes and RTU vials was created. Follow-up investments of around EUR 15 million are currently underway there to increase capacity for prefilled syringes (PFS). In Carugate, Italy, production capacities for the manufacture of semisolids and non-sterile liquids have been expanded with an investment of around EUR 10 million. At the Regensburg site, the new building for the development and production of highly active pharmaceutical ingredients (up to OEB 5) was opened in June 2023, a total investment of around EUR 25 million. Capacities for effervescent products will be almost doubled at the Bad Aibling site by 2025. Aenova is investing significantly in expanding production in the area of all common dosage forms.
<h5>Innovative technologies for novel therapies</h5>
The development of new drugs for a wide range of therapeutic areas is a steadily growing market and is progressing rapidly. Therefore, a smart innovation strategy is essential for contract developers and manufacturers.A CDMO should actively support customers with innovative approaches already during development services. At Aenova, there are currently various initiatives for differentiated technologies, which are primarily aimed at patient-friendly forms of therapy based on complex therapeutic systems and improved bioavailability of active ingredients.
Read more in the current issue of <a href="https://www.chemanager-online.com/produkte/wie-cdmos-zur-sicherung-der-medikamentenversorgung-beitragen" target="_blank">CHEManager 10/2023</a> (in German).

Carugate

Aenova invests in additional production capacity for semi-solids and non-sterile liquids at their Carugate site

12/10/2023 - Aenova invests in additional production capacity for semi-solids and non-sterile liquids

Carugate, 12/10/2023

Aenova is enhancing the existing infrastructure in four areas at its Carugate site (Italy), covering both pharmaceutical and cosmetic products. With an investment of around 10 million Euros, Aenova will be able to significantly increase its production capacity to meet increased market demand.
Semi-solids for pharmaceuticals, medical devices and cosmetics, as well as non-sterile liquids, continue to experience increasing demand. To meet these growing market needs, Aenova, a world leading Contract Development & Manufacturing Organisation (CDMO), is installing more modern and efficient equipment at its Carugate site (Italy). The investment of around 10 million Euros will enable four major projects to be implemented: A new filling line for non-sterile liquids, a more efficient turbo-emulsifier, a more complex filling line for cosmetics and a larger warehouse. 
 Aenova's Carugate site, with 145 employees, has been producing and packaging semi-solids for pharmaceuticals, medical devices and cosmetics, as well as non-sterile liquids, since 1994. The new filling line for non-sterile liquids will increase capacity to more than 10 million units per year. The versatile line also enables the filling of bottles with variable dosages from 10 ml to 350 ml and different types of closures (screw or crimp of metal and plastic cap, spray, dropper). The new turbo-emulsifier means that the facility can now manufacture batch sizes ranging from 300 litres to 5,000 litres. In addition to the increase in production, it will also be possible to produce other types of products, such as flammable liquids, as the area is ATEX rated. In the cosmetics sector, the current filling line will be replaced by a new modern high-speed line that can fill a wider variety of tubes of special sizes and shapes, including those with cannulas. The newly built warehouse next to the plant increases capacity by almost 3,000 pallet spaces, providing more than sufficient in-house GMP storage to meet the growing demand. "With the implementation of these four projects, we will effectively have a completely new plant with more modern and more efficient equipment by the end of 2023. This will not only enhance our capabilities, but also our position within the marketplace as a "Centre of Excellence for semi-solid and non-sterile liquid manufacturing", explains Marco Falzolgher, Managing Director of the Aenova site in Carugate. "Not only will we be able to better respond to market needs and customer requests, but we will also be able to expand our service offering to reliably provide products to patients and consumers around the world." "Within the overall investments of the Aenova Group, the capacity expansions for semi-solids and non-sterile liquids in Carugate are an important strategic building block. In line with our motto "Excellence beyond manufacturing", we want to be a reliable and agile partner for our customers in key market segments," comments Roel de Nobel, Chief Operations Officer of Aenova Group. The capacity expansions are expected to be completed by the end of 2023. Additional customer orders can be produced from 2024.

Aenova honored as best pharmaceutical company in "Germany's Best” 2023

28/09/2023 - Aenova honored as best pharmaceutical company in "Germany's Best” 2023

Starnberg, 28/09/2023

Aenova achieved the highest score in the pharmaceutical company category of the "Germany's Best 2023" study. With 100 points, Aenova, internationally active contract manufacturer and development service provider for the pharmaceutical and healthcare industry, came out on top as the best pharmaceutical company in the area of supplier reputation in the survey conducted by the renowned business magazine Focus Money.
 The award is based on an analysis conducted by the Institute for Management and Economic Research (IMWF) on behalf of DEUTSCHLANDS TEST among 20,000 companies and brands from more than 200 industries. The study evaluated over 400 million online sources in the period from May 2022 to April 2023 using the so-called social listening method. The data collection was carried out in two stages: first, all texts of German-language .de Internet domains were loaded into a database according to certain criteria. Subsequently, this data was split and analyzed according to predefined characteristics, e.g. tonality. In this way, information from a wide variety of online channels, such as websites, blogs, social media, forums, etc., is examined to find out which companies or brands have the highest provider reputation. The results of this study are based on around 44 million mentions of companies. The company always informs the public in a comprehensive and timely manner about the various developments within the Aenova Group. News from various areas, such as sustainability and social commitment, are published and addressed to all target groups, whether customers, partners, investors, candidates, young trainees or employees. There are also frequent reports from the 14 production sites of the Aenova Group, most of which are among the largest employers in their region, for example on capacity expansions and innovations in the development and production of pharmaceuticals. Aenova's lively and positive activities are thus reflected in this excellent rating. "First and foremost, it is the development of the Aenova employer brand that underlines the importance of the people who work for us in the company," explains Tim Bauer, Chief People Officer at Aenova. For Dr. Susanne Knabe, Head of Corporate Communication & PR, the award is the result of Aenova's open and transparent communication strategy: "We are very present on the Internet and regularly provide the public with freely accessible information. We simply have a lot of interesting topics to report on that contribute to this pleasing result."<figure><img src="https://www.aenova-group.com/content/_medium/Siegel_DT_Deutschlands-BESTE_2023_AENOVA-GROUP_1.-Platz.jpg" data-image="559444" alt="Deutschlands Beste 2023"><figcaption>Aenova was named the best pharmaceutical company in the area of supplier reputation (seal: DEUTSCHLAND TEST)</figcaption></figure>

Open House at Aenova Kirchberg site

19/09/2023 - Open House at Aenova Kirchberg site

Kirchberg, 19/09/2023

Aenova Kirchberg site produces highly potent drug products for the international pharmaceutical market. As one of the major employers in the region, the Aenova site opened its doors to the public on Saturday, September 16, 2023. There were guided tours of the laboratories and production; a festive restaurant with entertainment and a children's fun event rounded off the program of events. Around 1,000 interested guests visited the open day. The Aenova site in Kirchberg (SG), Switzerland, SWISS CAPS AG, develops and produces softgelatine capsules for the pharmaceutical industry, helping patients around the world to lead healthier lives. More than two billion capsules leave the factory every year and are distributed in over 100 countries worldwide, including Europe, the USA and China. In Kirchberg, softgel capsules are also filled with highly potent active ingredients in the lowest possible dosage, where the proverbial Swiss precision is required. Currently, a high-tech tropical blister line is being commissioned for such a new product to protect the drug even in extreme climatic conditions. Aenova is also investing heavily in sustainability in Kirchberg; with solar modules on flat roofs and carports, the site aims to generate more than 400,000 kWh of solar power annually itself in the future. Around 170 employees contribute to the success of the site. At the open day on September 16, 2023, interested parties from all over the region were able to take a look at the exciting world of pharmaceutical production. Around 1,000 visitors took the opportunity to look behind the scenes of the development and production of medicines "Made in Switzerland". During various plant tours, SWISS CAPS AG employees provided information on all questions. Visitors were also treated not only to food and drink stands, but also to entertainment provided by the Altoberndorf music band and the Gähwil male voice choir. For the children, fun was organized with the Jungwacht and Blauring Kirchberg, and there was a raffle with attractive prizes. "As one of the largest employers in the region, it was a great pleasure for us to give visitors a glimpse into the highly regulated world of pharmaceutical manufacturing. It's not something that happens every day. I would like to thank all those involved and, of course, all the interested guests," explains Dr. Christian Luftensteiner, Managing Director of Aenova's Kirchberg site.
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_TOFT_Kirchberg_Labor.jpg" data-image="559361" alt="Im Labor Kirchberg beim Tag der Offenen Tür"><figcaption>In the laboratory: Experts explain the activities in the laboratory to members of the Kirchberg municipal council (Photo: Aenova)</figcaption></figure>

Innovation is key. How CDMOs Can Contribute to Pharma Supply even Better

15/09/2023 - Innovation is key. How CDMOs Can Contribute to Pharma Supply even Better

Starnberg, 15/09/2023

In this special article, Aenova shows how important it is to keep your finger on the pulse with innovations. This enables CDMOs to partner with their customers from development through to commercial production and also provide early-stage support for innovative medicines. Aenova expert Dr. Klaus Pollinger, Head of Manufacturing Science & Technology at Aenova, will use various examples to show how CDMOs can help their customers with the rapidly increasing demand for novel drugs and full R&D pipelines. Read more in the special article in the current issue of <a href="https://www.chemanager-online.com/en/news/how-cdmos-can-contribute-pharma-supply-even-better" target="_blank">CHEManager International 3/2023</a>.<figure><img src="https://www.aenova-group.com/content/_medium/Article_Chem_092023.jpg" data-image="559330" alt="CDMO Aenova CHEManager 2023"><figcaption>From development to commercial supply. Full services with CDMO Aenova (Photos: Aenova)</figcaption></figure>

24 trainees start the new training year at the Aenova Group

08/09/2023 - 24 trainees start the new training year at the Aenova Group

Starnberg, 08/09/2023

The new training year is starting!
We welcome our 24 new trainees at the Aenova locations and wish them a good start into a varied and interesting training at Aenova!
Whether as
<ul><li>pharmacist or chemical laboratory assistant,</li><li>machine and plant operator,</li><li>industrial mechanic or warehouse logistics specialist,</li><li>industrial clerk or mechatronics technician ( all f/m/d):</li></ul>
our sites have received several awards as outstanding training companies, often with the best apprentices at the end of the year. Good luck to you all!
 
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_Trainees_2023.jpg" data-image="559197" alt="Aenova Trainees 2023"><figcaption>Some of the new trainees at Aenova Group</figcaption></figure>

New Aenova white paper in cooperation with c&en on "Development of highly potent medicines”

10/08/2023 - New Aenova white paper in cooperation with c&en on "Development of highly potent medicines”

Starnberg, 10/08/2023

HPAPIs (highly potent active pharmaceutical ingredients), provide precision treatment for cancer, autoimmune disorders, infectious diseases, and other medical conditions. Their safe handling is a challenge for drug manufacturers, who have to meet equipment, environmental and product quality requirements in the production and development of HPAPIs. HPAPIs represent one of the fastest-growing market segments in the global pharmaceutical industry. Aenova, as one of the world's leading CDMOs (Contract Development and Manufacturing Organization), offers its customers state-of-the-art facilities covering the complete life cycle from development to commercial supply with high flexibility and scalability. In collaboration with the renowned expert portal c&en, journal of the American Chemical Society, Aenova has now created a white paper specifically on the topic of how to challenge the increasing requirements in the production of HPAPIs by partnerships. Title of the whitepaper is "Supporting Development of Highly Potent Medicines with Manufacturing Flexibility”. CDMOs incorporating HPAPIs in their processes must take precautions at every step from development to production. This white paper describes e.g. the sophisticated production facilities, including isolators to contain material, personal protective equipment, and designated rooms with advanced air-handling-systems. The Aenova experts explain processing protocols and containment processes at the Aenova sites and point out how to achieve flexible, agile manufacturing coupled with operator safety and product quality. Aenova offers its customers a full service portfolio for high potent solids technologies (oncology, hormone therapy, immunomodulating therapy) from development to commercial production. 
The white paper "Supporting Development of Highly Potent Medicines with Manufacturing Flexibility” can be downloaded free of charge <a href="https://www.aenova-group.com/content/resources/Aenova_cen_Whitepaper_Development_HiPo_Drug_Products.pdf" target="_blank">under this link</a>.<figure><img src="https://www.aenova-group.com/content/news/_medium/Format_Change_high-potent_tablet-production.jpg" data-image="558670" alt="Format Change high-potent production"><figcaption>Format change, production of high-potent medicines</figcaption></figure>

The Aenova Group publishes Annual Report 2022

01/08/2023 - The Aenova Group publishes Annual Report 2022

Starnberg, 01/08/2023

The Aenova Group publishes its 2022 Annual Report today. The key figures 2022 of Aenova at a glance:
<ul><li>€ 749 million Net Sales 2022</li><li>€ 107 million adjusted EBITDA</li><li>+ 22% Order book</li></ul>
"We continued to expand our capacities to allow for future growth and continue to grow our technology offering to increase our competitiveness in the market," said Jan Kengelbach, CEO of Aenova Group. "We inaugurated a full new aseptic manufacturing facility for high-speed PFS and vial filling including large molecule fill and finish. Our new high-speed, large volume solid plant expansion in Tittmoning went online, and we continued to build our expansions in Kirchberg for softgel capsule packaging. We made good progress in Carugate building a high-speed liquids and semi-solid manufacturing or in Regensburg establishing a future high-potent manufacturing to come online in 2024 and 2025 respectively. This strategy of capacity expansion and capability extension through the introduction of new technologies and superior development service offering continues to serve us very well”, Jan Kengelbach added. Learn more about Aenova's 2022 achievements and milestones, as well as key events in each business unit.
Read <a href="https://www.aenova-group.com/content/Aenova_Annual_Report_2022.pdf">more</a>.

Aenova Latina site and Edison Next strengthen partnership by continuing the energy transition

27/07/2023 - Aenova Latina and Edison Next strengthen partnership

Milan / Latina, 27/07/2023

<h5>New photovoltaic plant of more than 1 MW</h5>
Edison Next, an Edison Group company that accompanies customers and territories on their path to decarbonization and energy transition, and Haupt Pharma Latina, member of the Aenova Group, that is among the world leaders in the pharmaceutical field, take another important step along the road to decarbonization of the Borgo San Michele production site in Latina, which, with 600 employees and 40,000 square meters of floor space, is one of the largest in the entire Aenova Group and is located in an area considered the pharmaceutical hub of Lazio. Specifically, Edison Next, under a 15-year contract signed with Aenova, will be responsible for the design, installation, maintenance and operation of a new 1.135 MW solar tracking photovoltaic plant to be installed on the ground within the production perimeter of the Latina site. The plant, which will be commissioned by the end of the year, will be capable of producing more than 2,000 MWh per year. The new photovoltaic plant, built under a PPA (Power Purchase Agreement) formula, will have an area covering about 4,800 square meters and will consist of 10 inverters and more than 1,800 modules, mounted on solar tracking support structures with a north-south orientation. "The construction of this photovoltaic plant represents a further step in the path begun a few years ago together with Aenova with the aim of improving the sustainability and energy autonomy of the Latina site," says Marco Steardo Director of Industry at Edison Next. "Photovoltaics represent a strategic resource for the energy transition of companies. It is a well-established and mature technology that can ensure immediate benefits in terms of, both environmental impact and energy cost reduction. In fact, self-producing renewable energy also means increasing one's independence from the grid by decreasing one's exposure to price volatility." "Environmental sustainability combined with economic levers are the key to our future, as a company, as a relationship with our territory. We have a responsibility to improve year after year and to look to future generations," says Paolo Abbate, managing director of Haupt Pharma Latina, member of the Aenova Group. "The partnership with Edison Next is a virtuous example of how common goals can make Europe and our customers create synergies and bring competitiveness. It is a positive model to be replicated on many other challenges of innovation and technological improvement." The share of self-consumption of renewable electricity produced by the photovoltaic system built by Edison Next will be about 80%. The remaining portion that is not self-consumed will be fed into the grid. This plant represents a new piece in the journey that Edison Next and Aenova began together almost a decade ago with the goal of increasing energy independence and decreasing the environmental impact of the Latina site. This photovoltaic plant will make it possible to meet 23 percent of the plant's electricity needs, taken to date from the grid, through renewable sources and, adding to other energy solutions already implemented by Edison Next, will make it possible by the end of the year to meet a substantial portion of the site's energy needs through self-generation. The result will be an estimated reduction in atmospheric emissions of 746 tons of CO2 per year.(1) (1) Total avoided emissions are equal to the difference between emissions for thermoelectric production from fossil sources and emissions for production from photovoltaics (equal to 0). Emissions from thermoelectric production are calculated by multiplying the expected electricity production by the emission factor of the Italian thermoelectric fleet as defined in ISPRA environmental reports.
<figure><img src="https://www.aenova-group.com/content/news/_medium/Aenova_Latina_Site.jpg" data-image="558218" alt="Aenova Latina site in Italy"><figcaption>Aenova Latina site in Italy (Photo: Aenova)</figcaption></figure>

Innovative drug formulations make medicines more patient-friendly: Aenova and Galvita enter strategic partnership

13/07/2023 - Aenova and Galvita enter strategic partnership

Starnberg / Basel, 13/07/2023

The Aenova Group is a leading global contract manufacturer and development service provider for the pharmaceutical and healthcare industry. As a full service provider, Aenova develops, produces and packages all common dosage forms, product groups and active ingredient classes from pharmaceuticals to dietary supplements for human and animal health. Galvita is an innovative Swiss start-up company specializing in the development of patient-friendly, age-appropriate dosage forms.
Aenova and Galvita have entered into a strategic partnership effective July 1, 2023. The aim of the partnership is to improve the development, formulation and production of oral dosage forms. To this end, Galvita brings knowledge of specific child- and senior-friendly formulations that feature faster oral disintegration, better taste masking and higher drug loading than oral dosage forms currently available on the market. Galvita's revolutionary and patented Templated-Inverted Particles (TIP) technology consists of clinically tested calcium-phosphate microcapsules that can be loaded with a wide variety of active ingredients via a self-loading mechanism. The capsules are then processed into tablets. These tablets have the property of disintegrating almost instantly upon ingestion, releasing the active ingredient. Patients with swallowing disorders (dysphagia) can thus be supplied effortlessly. Another advantage is taste masking of active ingredients. This technology thus increases acceptance and adherence to therapy, especially among special patient groups such as children and the elderly. Above all, it offers an alternative to intramuscular injection in many cases. As a broad-based CDMO (Contract Development and Manufacturing Organization), Aenova brings many years of expertise, extensive GMP knowledge, international resources, rapid scalability and effective market access for the technology to the partnership. As Galvita's strategic industrial CDMO partner, Aenova will offer this technology for customer projects at its site in Sisseln, Switzerland. Aenova's Sisseln site is the Competence Center for complex solids within the Aenova network and develops and produces innovative, customized solutions for oral solid dosage forms. The two managing directors of the new partners, Jan Kengelbach, CEO of Aenova Group, which is the industry partner of the cooperation, and Dr. Roland Haag, co-founder and CEO of Galvita, agree: "The portfolio and the experience and knowledge of the individual companies complement each other perfectly in order to be able to offer an almost unique added value even faster for our customers and, above all, for patients worldwide." 
<figure><img src="https://www.aenova-group.com/content/news/_medium/Mikroskopaufnahme-TIP-Galvita.png" data-image="558089" alt="TIP Galvita"><figcaption>Close-up of a TIP microcapsule that can be loaded with a wide variety of active ingredients (Photo: Galvita)</figcaption></figure><figure><img src="https://www.aenova-group.com/content/news/_medium/Tablettenherstellung-Sisseln.jpg" data-image="558096" alt="Tablettenherstellung Sisseln"><figcaption>Tablet production at Aenova's Sisseln site (Photo: Aenova)</figcaption></figure>

Aenova opens new building for the production of highly potent drugs at the Regensburg site

23/06/2023 - Aenova opens new building for the production of highly potent drugs at the Regensburg site

Regensburg, 23/06/2023

Aenova opened its new building for highly potent active ingredients at the Regensburg site on June 22, 2023. Highly potent drugs against cancer, among other things, are produced in the new production facilities. With a total investment of around 25 million euros at the Regensburg site, Aenova will thus be able to significantly increase its development and production capacities for the increased market demand for highly effective drugs.
Cytotoxics and cytostatics are in increased demand in the global pharmaceutical market. To meet this steadily increasing demand, Aenova, the world's leading development service provider and contract manufacturer for the pharmaceutical and healthcare industries, has built a new building at its Regensburg site for the development and production of highly effective active pharmaceutical ingredients. The total investment of around €25 million will enable the company to significantly expand its production of highly potent active ingredients up to OEB 5 and, in particular, of cancer drugs. The new building was opened on June 22, 2023. The Aenova site in Regensburg has been developing and producing tablets and capsules with highly potent active ingredients such as methotrexate, hydroxycarbamide, azathioprine, imatinib since the 1950s. These are, for example, drugs for the treatment of inflammatory diseases such as psiorasis or arthritis, against autoimmune diseases, drugs against cancer such as leukemia, but also novel drugs (so-called New Chemical Entities, NCE). The special feature of many of these drugs is their high efficacy, which means that the active ingredients already have the desired effect in the smallest doses, but special safety standards must therefore also be observed during development and production. The new four-story building with a total building area of more than 4,000 m² houses the production and packaging of highly potent tablets as well as the associated laboratories, development, storage and social rooms. This means a significant expansion of the production area and the areas of development and laboratory by over 2,100 m² at the Regensburg site. After the planned start-up at the beginning of 2024, the production capacities can thus be increased in volume by significantly more than 1 billion tablets and capsules. An entire floor is reserved for flexible customer requests for "on demand" production, so that existing and new customers can be individually supported in line with their requests. The new building is part of the strategic profiling of the Regensburg site for the development and production of highly effective medicines. Around 400 people are employed at the Regensburg site. The Regensburg site is "Competence Center HPAPI & Oncology Products" within the Aenova Group with leading HPAPI development, production and packaging facilities for high-potent solids. “The new building is an important milestone for this," explains Oliver Schmied, Managing Director at the Aenova site in Regensburg. “Producing billions of tablets and capsules each year, Aenova is a partner of choice for novel product solutions as well as commercial high-volume manufacturing. A particularly unique selling point is that we offer production flexibility using harmonized production equipment, enabling small to large batches from 0.5 to 500kg for development, CTM, scale up and commercial batches," continues Oliver Schmied. "Within the overall investments of the Aenova Group, the new building for highly potent APIs in Regensburg is an essential strategic building block. As a development and manufacturing partner, we are thus a reliable and agile CDMO (Contract Development & Manufacturing Organization) for our customers in the promising market segment of highly potent active ingredients," comments Jan Kengelbach, CEO of the Aenova Group. With the new building, Aenova will not only be able to better serve market needs and customer requests in the future, but above all reliably provide vital medicines for patients with cancer worldwide. In the next few months, the laboratories and the new "on-demand" GMP area will be set up. Customer orders can go into production from 2024.
<figure><img src="https://www.aenova-group.com/content/news/_medium/Aenova-Regensburg_Opening-Ceremony.jpg" data-image="557849" alt="Ceremony Regensburg"><figcaption>Ceremonial opening of the new building for highly effective pharmaceuticals at the Aenova site in Regensburg. From left: Tim Bauer, Chief People Officer of the Aenova Group, Regensburg's Mayor Gertrud Maltz-Schwarzfischer, Oliver Schmied (Managing Director Aenova Regensburg), Dietmar Rohleder (Prange Group) (Photo: Aenova)</figcaption></figure>
<figure><img src="https://www.aenova-group.com/content/news/_medium/Aenova_Regensburg_New-Building.jpg" data-image="557848" alt="New building Regensburg"><figcaption>The new building for highly effective pharmaceuticals at the Aenova site in Regensburg, Germany (Photo: Aenova) </figcaption></figure>

Aenova receives rating “Highest reputation: outstanding" in Focus Money Germany test

20/06/2023 - Aenova receives rating “Highest reputation: outstanding" in Focus Money Germany test

Starnberg, 20/06/2023

Aenova has been awarded the rating "Highest reputation: outstanding" by the german business magazine Focus Money. The award is based on a study by the Institute for Management and Economic Research (Institut für Management und Wirtschaftsforschung, IMWF), which analyzed the reputation of the 20,000 largest German companies in the areas of management, sustainability, product and service, performance. For this purpose, a total of 20 million reviews - customer ratings, testimonials, comments and more - from the Internet on the tested companies in the period from February 2022 to January 2023 were recorded and evaluated. Of the 20,000 companies, 1,000 received the "Highest Reputation" seal of approval and Aenova was able to position itself in the pharmaceutical sector alongside major international pharmaceutical companies with the award. "We are very pleased to receive this award," commented Jan Kengelbach, CEO of Aenova Group. "It reflects very well how the Aenova Group has developed over the last two years in the areas of performance, product, service, management and sustainability. This is a joint success to which every colleague has contributed!"
<figure><img src="https://www.aenova-group.com/content/news/_medium/Siegel_DT_Höchste-Reputation_2023_AENOVA-GROUP.jpg" data-image="557814" alt="Focus Money Auszeichnung für Aenova"><figcaption>Focus Money Award for Aenova</figcaption></figure>

Aenova with new organizational structure supporting future strategy

15/06/2023 - Aenova with new organizational structure supporting future strategy

Starnberg, 15/06/2023

Aenova has reorganized the company's organizational structure. The new management structure of the Executive Leadership Team is aligned with the company's growth strategy. Manufacturing operations, development and technology innovation are now positioned powerfully and equally alongside each other.
The Aenova Group, amongst the globally leading international contract manufacturers and developers for the pharmaceutical and healthcare industries, announces a new organizational structure for the Executive Leadership Team (ELT). The new management structure is aligned with the company's meticulous focus on operational excellence while supporting its growth strategy in development services. From now on, the new structure is giving equal clout to manufacturing operations as well as development services and technology innovation. “This reorganization will very well support Aenova's strategic positioning as an innovative CDMO champion”, explains Jan Kengelbach, CEO of the Aenova Group. “While the demand on our manufacturing services is higher than ever contributing to more than 20% organic growth year-to-date, so is the demand for our development services in particular in the high potent solids, solids with enhance bioavailability characteristics, and aseptic manufacturing. We are currently working on 60 development projects with our customers in clinical phase 1-3”, Jan Kengelbach continues. Specifically, this means that from now on all 14 manufacturing sites of Aenova Group will report directly to Roel de Nobel, the new Chief Operations Officer (COO). Florent Bordet, as new Chief Scientific Officer (CSO), will be the head of the newly created development services and technology innovation unit. This will cover product development, development services and manufacturing science and technology.
Chief Commercial Officer (CCO) Neil Jones will be responsible for the management of the existing business and drive the development and acquisition of new business opportunities. Tim Bauer as Chief People Officer (CPO) will continue to drive initiatives around employee engagement, employee motivation and talent acquisition. Dr Peter Waller was recently appointed as new Chief Financial Officer (CFO). The organizational changes are in line with Aenova's ambitious strategic direction as an innovative CDMO champion. This is focused on delivering ever higher output levels at highest quality and reliable delivery rates by expanding the manufacturing capacities across the network. And in addition, also it focusses on extending capabilities to offer more differentiated technologies and development capabilities for small molecules and large molecules fill and finish. With this, Aenova offers its customers solutions both for established molecules as well as the development of new chemical entities (NCE). "I look forward to shaping the future of Aenova together with this experienced, dedicated and visionary team. With Aenova's innovative solutions and outstanding capabilities, our customers have a reliable CDMO partner at their side for all their needs", comments Jan Kengelbach, CEO of the Aenova Group.<figure><img src="https://www.aenova-group.com/content/news/_medium/AE_ELT_qu.jpg" data-image="557771" alt="Aenova Executive Leadership Team 2023"><figcaption>Aenova Executive Leadership Team 2023</figcaption></figure>

Efficient handling of high-potent APIs, a CDMO perspective (lecture at 8th Annual High Potent Medicines Conference Milan 2023)

12/06/2023 - Efficient handling of high-potent APIs

Starnberg, 12/06/2023

In her lecture at the 8th Annual High Potent Medicines Conference on 24 / 25 May 2023 in Milan, Dr. Martina Breuer, Head of Operations, Aenova Group, addressed current challenges and strategies in handling of high-potent active pharmaceutical ingredients (HPAPIs). The agenda included an overview of the definition of high potent APIs /products, and their toxicology and safety implications in the processing, market insights and the smart and efficient production concept for handling HPAPIs with examples from Aenova's development and manufacturing sites. HPAPIs are significantly growing in today’s drug therapy and R&D pipelines. Today’s pharmaceutical development and manufacturing see a strong trend in outsourcing to service providers being experts in their fields. To master the challenges in flexibility and efficiency CDMOs must implement a holistic concept to HPAPI handling. Dr. Breuer focused on the aspect of shared facilities versus dedicated facilities and the regulatory requirements for high quality, safe and flexible manufacturing in shared facilities. For deeper insights see the Aenova <a href="https://www.aenova-group.com/content/resources/Aenova_Whitepaper_Safe-and-efficient-handling-of-high-potent-drug-products.pdf" target="_blank">whitepaper on “Safe and Efficient Handling of high-potent Drug Products”.</a><figure><img src="https://www.aenova-group.com/content/_medium/Aenova_Closed_Containment_Graphic_mR.PNG" data-image="557732" alt="Closed Containment Graphic"><figcaption>Aenova Closed Containment Concept (Graphic: Aenova)</figcaption></figure>

Career orientation fair in Regensburg

07/06/2023 - Career orientation fair in Regensburg

Regensburg, 07/06/2023

At the beginning of May, the large career orientation fair of the Employment Agency and with partners from schools and business took place in the Danube Arena in Regensburg. Around 2,000 students learned about apprenticeships and career opportunities in a wide variety of fields: Craft, natural science, pedagogy, health, economy. Over 130 exhibitors presented their companies.
The Aenova site in Regensburg also participated in the fair. The demonstration of experiments at the Aenova booth and the many opportunities that the pharmaceutical industry offers for young people attracted lively interest. Aenova in Regensburg offers training in the following professions:<ul><li>Chemical laboratory assistants (m/f/d)</li><li>Pharmacist (m/f/d)</li><li>Mechatronics technician (m/f/d)</li></ul>
The locations of the Aenova Group have already been awarded several times by the IHK for excellent training.
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_RGB-Messe_Gruppe.jpg" data-image="557701" alt="Berufsbildungsmesse Regensburg"><figcaption>The Aenova team Regensburg at the career orientation fair in May 2023</figcaption></figure>

Sisseln

Successful recertifications at Aenova site Sisseln

31/05/2023 - Successful recertifications at Aenova site Sisseln

Sisseln, 31/05/2023

Aenova, the world's leading development service provider and contract manufacturer for the pharmaceutical and healthcare industries, secures recertifications. In March 2023, Aenova's Sisseln site again successfully passed certification in ISO 9001 Quality Management System, ISO 14001 Environment, ISO 45001 Occupational Health and Safety, and FSSC 22000 Food Safety. The certifications must be repeated every three years. The Aenova Group's production site for complex conventional solids in Sisseln, Switzerland, has been certified in various ISO areas for more than ten years and relies on an effective management system for quality, environment, occupational health and safety, and food safety. Particularly because of its activities in the area of pharmaceutical products, effective management in these areas is important in order to demonstrate performance to employees and customers as well as to the community and the authorities. In terms of environmental performance, the Sisseln site has long demonstrated its responsibility: it operates free of fossil energy with 6 GwH of electricity from hydropower, uses also its own photovoltaic systems and is climate-neutral. "The Aenova site in Sisseln has special know-how and state-of-the-art infrastructure for the production and packaging of moisture-sensitive solid dosage forms and innovative technologies. We are highly aware of our own and our customers environmental responsibility. Obtaining several certificates at once makes us proud and confirms that we are setting the right priorities and are on a good path to a sustainable future," says Fridrik Thorsteinsson, Managing Director at the Aenova site in Sisseln..
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_Sisseln_Frontview.jpg" data-image="557667" alt="Aenova Sisseln Haupteingang"><figcaption>Aenova site in Sisseln successfully recertified; on the right roof, solar panels as in operation on all roofs of the CO2-free site. (Photo: Aenova)</figcaption></figure>

Peter Waller appointed as new CFO of Aenova

17/05/2023 - Peter Waller appointed as new CFO of Aenova

Starnberg, 17/05/2023

Effective May 15, 2023, Dr. Peter Waller has been appointed as the new Chief Financial Officer of Aenova Group and Managing Director of Aenova Holding GmbH. "I am looking forward to contributing to Aenova's further success," commented Peter Waller on his start at Aenova. "The Aenova Group has a strong reputation as a development service provider and contract manufacturer for the pharmaceutical and healthcare industry and is well positioned for future profitable growth in coming years." Peter Waller succeeds CFO Ralf Schuler.
Peter Waller is an experienced CFO of international companies in various industries including Flender, Swissport International, CEVA Logistics and Eurofins. He has successfully led numerous transformations, IPOs, financings and M&A activities. Peter Waller holds Master´s degrees in Management from the University of Mannheim and the ESSEC Business School in Paris and a PhD in Economics from the University of Paderborn. Aenova's previous CFO, Ralf Schuler, will be available in the coming months to ensure a seamless transition. "We are delighted to welcome Peter Waller to our team. Peter has extensive experience to support the development of Aenova Group," explains CEO Jan Kengelbach. "With his drive and knowledge, Peter Waller will be a great asset to our team. At the same time, I would like to thank Ralf Schuler for his outstanding commitment over the past five years, during which he has played a key role in the successful repositioning of Aenova Group as our CFO." The Aenova Group is one of the leading international CDMOs (Contract Development and Manufacturing Organizations) for the pharmaceutical and healthcare industry. With around 4,100 employees at 15 locations worldwide, the company recorded sales revenues of around EUR 750 million in 2022.

Enabling innovation: challenges and strategies in solid dosage forms drug development services (lecture at World Pharma Summit 2023)

05/05/2023 - Enabling innovation: challenges and strategies in current drug development

Starnberg, 05/05/2023

In his lecture at the World Pharma Summit 2023 on April 26, 2023 in Frankfurt, Dr. Klaus Pollinger, Head of Manufacturing Science & Technology, BU Solids at Aenova, addressed challenges and strategies in current drug development. 
The agenda included an overview on current challenges and their backgrounds as well as the formulation of poorly soluble drugs and a case study. First, the speaker gave an overview of the current situation in research and development and, in particular, outlined the expectations that are placed on a development service provider today. Regarding the formulation of poorly soluble drugs, Klaus Pollinger explained trends and classifications and presented selected technologies. He concluded his presentation with case study on successful improvement of bioavailability in solid oral dosage forms. In summary, Klaus Pollinger emphasized how important development service providers can be in driving innovation in pharmaceutical development. By offering comprehensive know-how and an end-to-end service, customers ultimately benefit from cost and risk minimization as well as optimized timelines. Aenova supports drug projects with long and deep experience in development services through to commercial manufacturing, investments in expanded capabilities, new technologies and end-to-end services.<figure><img src="https://www.aenova-group.com/content/navigation/_medium/KP-auf-WPS-2023.JPG" data-image="557326" alt="Lecture Aenova WPS 2023"><figcaption>Aenova lecture on challenges in current drug development at the World Pharma Summit 2023</figcaption></figure>

CEO Jan Kengelbach about Trends in CDMO Market (Interview in GBR Life Sciences Report 2023)

27/04/2023 - CEO Jan Kengelbach about Trends in CDMO Market (Interview in GBR Life Sciences Report 2023)

Starnberg, 27/04/2023

In the latest edition of Global Business Reports' renowned US Life Sciences 2023 Report, Aenova outlines not only trends in the CDMO market but also highlights in capacities and capabilities at Aenova. In the interview, Aenova CEO Jan Kengelbach also explains latest achievements: "(...) About four years ago, we designed a new growth strategy. First, each site had to become a center of excellence for a certain technology, and second, in each site, we made the investment decisions to either expand existing capacities or extend the technology offering. In total, there are 15 new growth platforms at Aenova now, of which eight are commercially online yet. As an example of capacity expansion, we extended our high-volume Tittmoning site, Germany, to 10bn tablet capacity. We created a brand new sterile area fill and finish area (including biologics) for prefilled syringes and RTU vials at our Latina Site, Italy. The breadth of new technologies that we have put online is including the new high-potent API facility at our Regensburg site, Germany, the hot melt extrusion and templated inverted particles at our Sisseln site, Switzerland, or the new dry powder inhaler/microdosed capsule filling at our Münster site, Germany (...)." Read more in the <a href="https://projects.gbreports.com/united-states-life-sciences-2023/aenova-group-interview" target="_blank" style="margin: 0px; padding: 0px; border: 0px; font: inherit; vertical-align: baseline; text-decoration: none; color: rgb(51, 151, 255); cursor: pointer; outline: 0px !important; box-sizing: inherit;">GBR US Life Sciences Report 2023</a>.

Aenova receives silver medal in EcoVadis sustainability rating

06/04/2023 - Aenova receives silver medal in EcoVadis sustainability rating

Starnberg, 06/04/2023

Aenova, one of world's leading contract development and manufacturing organisations for the pharmaceutical and healthcare industries, has achieved silver status in the latest EcoVadis sustainability rating. This documents the Aenova Group's continuous improvement of its sustainability in the categories "environment", "labor and human rights", "ethics" and "sustainable procurement".
Certified proof of sustainability in the areas of environment, labor, ethics and procurement is becoming increasingly important for companies and their suppliers. Around half of the world's leading pharmaceutical companies use the EcoVadis assessment for this purpose. The Aenova Group also undergoes an annual assessment by EcoVadis. In the areas of environment and labor and human rights, the best results were achieved with 70 out of 100 maximum possible points. With a percentile of 84, Aenova is among the top 25 percent of companies evaluated by EcoVadis. The production steps in the pharmaceutical industry are energy-intensive. A good Ecovadis result also distinguishes responsible action in the use of natural resources. According to Ecovadis, around 91% of companies now take sustainability criteria into account when making purchasing decisions. "Sustainability is not an empty phrase for us, but an important strategic goal," says Jan Kengelbach, CEO of Aenova Group. "Our sustainability strategy always includes further optimization in sustainability and environmental topics. For example, the Aenova site in Sisseln already operates completely CO2-free, many sites have photovoltaic systems as well as special wastewater treatment or their own combined heat and power plants, and we are continuously expanding the sites." The EcoVadis methodology covers a total of seven management indicators, comprising 21 sustainability criteria in four thematic areas: Environment, Labor and Human Rights, Ethics and Sustainable Procurement. It is based on leading standards such as GRI (Global Reporting Initiative), UNCC (UN Climate Change) and ISO 26000, and is overseen by an international scientific committee. It evaluates companies' performance by analyzing policies, measures and results.

Roel de Nobel new Head of Business Unit Solids at Aenova

23/03/2023 - Roel de Nobel new Head of Business Unit Solids at Aenova

Starnberg, 23/03/2023

As of February 01, 2023, Roel de Nobel is the new Senior Vice President of the Business Unit Solids at the pharmaceutical company Aenova. As a member of the Executive Leadership Team (ELT), he will play a key role in shaping the future and success of Aenova Group's seven solids sites, reporting directly to CEO Jan Kengelbach in his role.
Since February 01, 2023, Roel de Nobel has joined the Aenova Group as the new Senior Vice President of the Business Unit Solids and General Manager. As a member of the Executive Leadership Team (ELT), he will lead and significantly develop Aenova's total of seven solids sites. "I am delighted to be part of Aenova's success story now," comments de Nobel on joining Aenova. "Aenova’s expertise, capabilities and capacities in solid oral dosage forms is impressive. Together with my colleagues, we will do our best every day for our customers and thus for the supply of medicines to patients worldwide." De Nobel has extensive experience in the international consumer goods and pharmaceutical sectors and brings with him many years of expertise in the CDMO environment. He previously held various senior positions at Catalent, including Global Vice President Operations and Vice President & General Manager Asia Pacific. De Nobel studied Business Administration and Management.
The Business Unit Solids at Aenova provides not only high-volume production capacities for capsules, tablets and film-coated tablets, but also supports customers with innovative technologies focused on complex therapeutic systems or aimed, for example, at improving the bioavailability of the API. This means e.g. hot melt extrusion or co-precipitation, encapsulated mini tablet systems or multi-unit pellet systems (MUPS). These innovations also include projects in the field of highly potent drugs, particularly in oncology, in order to offer patients a simplified and less burdensome form of therapy.
With his extensive expertise, Roel de Nobel will place a special focus on the further development of Development Services and Clinical Trial Management (CTM). "In this way, we can offer our customers a particularly comprehensive service, as Aenova can provide almost freely scalable experience and competent support, from development, i.e. very small batches, up to high-volume commercial production, this all from a single source", explains de Nobel. "We are delighted to welcome Roel de Nobel to our team. Roel is a very experienced manager in the pharmaceutical industry and will expand the solid dosage form development within Aenova," comments CEO Jan Kengelbach. "Roel de Nobel will enrich our team with his drive, his ability to innovate and last but not least with his personality."

Aenova introduces new sterile strategy

10/03/2023 - Aenova introduces new sterile strategy

Starnberg, 10.03.2023

Aenova Group, a leading international contract developer and manufacturer for the pharmaceutical and healthcare industries, presents its new sterile strategy. In the future, the focus in sterile production will be on expanding the sterile site in Latina (Italy). There, portfolio and capacities are being expanded, especially in the area of prefilled syringes (PFS) as well as intramammary syringes.
Aenova Group, a leading international contract manufacturer and developer for the pharmaceutical and healthcare industries, has launched a restructuring program for its Sterile Manufacturing business within the semi-solida and liquida business unit. This is aimed at significantly expanding capacity at the large Aenova sterile site in Latina, Italy.Over the past 24 months, more than 20 million euros have been invested in the Latina plant to offer customers a high-performance site with state-of-the-art filling technology for sterile dosage forms, especially vials and PFS. This new manufacturing area has already been approved by the Italian authorities. Follow-on investments of approximately 15 million euros are currently underway to further expand the offering. This is mainly aimed at increasing capacity for prefilled syringes (PFS). This is Aenova's response to the market demand for PFS and the increased customer requirements for this fast-growing sterile dosage form. With further expansions, Aenova is also positioning itself as a service-oriented end-to-end provider in this area. In the course of this concentration, consequences will be drawn at Aenova's other sterile sites, as a comprehensive reorganization of the sites is not economically feasible, in particular due to the additional regulatory requirements for sterile production that are now coming into force. Therefore, the site in Wolfratshausen, Haupt Pharma Wolfratshausen GmbH, will be closed in 2023 and the sterile manufacturing sub-segment at the Gronau site, Haupt Pharma Wülfing GmbH, will be discontinued. Customer projects should be transferred or completed according to plan. At the Gronau site, the focus in the future will be on the successful solida business with capacity expansions already being implemented. "Our restructuring and focus on our Latina sterile site is targeting a growth market. This pays off for the entire Aenova strategy. It puts us in an excellent position for the future," explains Jan Kengelbach, CEO of the Aenova Group.

Marburg

New Managing Director at Aenova site in Marburg, Germany

01/03/2023 - New Managing Director at Aenova site in Marburg, Germany

Marburg, 01/03/2023

Effective March 01, 2023, Dr. Hanno Scheffczik has been appointed as the new Managing Director of Temmler Pharma GmbH, a member of the Aenova Group. The experienced general manager leads the site in Marburg with 150 employees and a focus on complex conventional solids and narcotics.
The Aenova Group is a leading international contract manufacturer and developer for the pharmaceutical and healthcare industry with 16 locations and around 4,200 employees worldwide. The Aenova site Marburg stands out within the group as a competence center for complex conventional solids and narcotics. With around 150 employees, the Aenova site in Marburg manufactures delayed-release tablets and capsules as well as moisture-sensitive dosage forms. Dr. Hanno Scheffczik has been appointed as the new Managing Director as of March 01, 2023. He replaces the long-standing managing director Dr. Alfred Veit, who is retiring.Dr. Hanno Scheffczik studied chemistry with a focus on biochemistry and earned his doctorate at the Institute of Virology at Philipps University in Marburg. After holding various development and management positions at well-known, international research-based pharmaceutical companies, he joined Aenova in 2021, initially as Head of Manufacturing Science & Technology. "I am looking forward to my tasks in Marburg and to working with a highly competent and committed team!", says Dr. Scheffczik. The Aenova site in Marburg has a history of over a century in pharmaceutical development and production and is one of the larger local employers. The company has particular expertise in the development and production of complex pellets with controlled release of active ingredients, such as encapsulated mini-tablets and multi-unit pellet systems (MUPS). This is aimed at improving the bioavailability of active pharmaceutical ingredients and is an example of the innovative strength of the Aenova site in Marburg. The site is GMP and FDA certified, among others. "With Dr. Scheffczik we have a long-standing experienced manager and expert who knows the industry and Aenova very well. We wish him every success in his new role," explains Jan Kengelbach, CEO of the Aenova Group.

Aenova employees donate to the Starnberger Tafel

07/02/2023 - Aenova employees donate to the Starnberger Tafel

Starnberg, 07/02/2023

Employees of the pharmaceutical contract manufacturer Aenova organized an internal donation for the Starnberger Tafel in December 2022. The official, symbolic handover of the check took place on February 2, 2023.
Starnberg, February 03, 2023 - The war in Ukraine, increased energy prices and inflation hit disadvantaged and socially weaker people particularly hard. Therefore, employees of Aenova, a global contract developer and manufacturer for the pharmaceutical and healthcare industry, organized a donation initiative before Christmas. At the Aenova headquarters in Starnberg, the employees collected a sum of money for the "Starnberger Tafel", a charitable organization that gives food that would be wasted to people in need. The joint donation amounts to 1,500 euros.
On February 02, 2023 the official, symbolic check handover took place. Two employees of Aenova visited the "Starnberger Tafel", informed themselves about the work of the Tafel and helped with the food distribution.
"Picking up and sorting the food is very time-consuming and the volunteers at the Starnberger Tafel work outdoors in all weathers", reflects Dr. Irayani Berger, Vice President Corporate Quality at Aenova. "A great commitment!", adds Dr. Susanne Knabe, Head of Corporate Communication at Aenova. "We are happy to be able to help people in the local area of Aenova's headquarters in Starnberg with the joint donation of our employees."
"We are very grateful for this unforeseen donation. Such donations support us in our work. There are many needy citizens who urgently need the food we collect", explains Erika Ardelt, first chairwoman of the board at Starnberger Tafel. 
<figure><img src="https://www.aenova-group.com/content/navigation/_medium/Aenova_Spendenscheckübergabe_Starnberger_Tafel_02022023_kl.jpeg" data-image="556517" alt="Scheckübergabe Starnberg"><figcaption>Symbolic handover of the employee donation at the Starnberger Tafel: from left Doris Heger, treasurer of the Starnberger Tafel, Dr. Irayani Berger and Dr. Susanne Knabe, both Aenova, Christina Bolz, secretary at the Starnberger Tafel (Photo: Starnberger Tafel)</figcaption></figure>

Aenova successfully expands capsule filling capacity

11/01/2023 - Aenova successfully expands capsule filling capacity

Regensburg, 11/01/2023

Producing billions of capsules each year, Aenova is a partner of choice for novel product solutions as well as commercial high-volume manufacturing of hard capsule products.
At the Regensburg site, one of the leading HPAPI development, production and packaging facilities for high potent solids, production flexibility is a key issue. For this reason, the equipment at the site was expanded with a state-of-the-art IMA capsule filling machine: IMA Adapta 200. Oliver Schmied, Managing Director at the Regensburg site, explains the background in an interview with the machine manufacturer.
<h5>What were the drivers behind the project to expand your capsule filling capacity?</h5>
Having acquired new business involving large volumes of capsules to be produced at the Regensburg site, we were faced with the need to significantly increase our filling capacity as early as possible. Our focus was on obtaining highly efficient processes with a view to achieving maximum flexibility to best meet all customer requirements. It was evident from the start that we needed to implement the most recent, innovative technologies to reach our goals.
<h5>In terms of engineering capabilities and process optimisation, how would you describe the collaboration with IMA Active?</h5>
We had to address a number of issues, some of which were critical, so the most valued aspect of our relations with IMA can be summed up in a few words: transparent, open discussions and constructive input to find all the right answers. This is the basis of a true professional partnership and the benefits go in both directions, to the customer and the supplier. To mention one issue, considerable efforts were made by IMA’s engineering team to successfully install the new ADAPTA capsule filler into extremely limited floor space. Further to this, we were assured that the ADAPTA 200 could handle our products and during the preparatory stages of the FAT (Factory Acceptance Test; FAT is one of the qualification phases in the course of GMP qualification), together we were able to test the products of the machine and implement the ideal settings to guarantee optimum results.
<h5>Collaboration with IMA Active dates back to 1990, with acquisition of the first ZANASI capsule filler. Can you retrace the milestones of this partnership?</h5>
That’s right. 1990 marked the first purchase of a ZANASI capsule filler, the ZANASI 40 for commercial purposes. We then bought an additional ZANASI 5 and in 2021 acquired a ZANASI 12 which was devoted to batch development activities at our pilot plant, which was established as an in-house development facility between 2009 and 2010. Most of the products have been developed using the ZANASI equipment and subsequently tested and successfully manufactured on ADAPTA using the same filling principle. This eloquently reflects our many years of in-depth know-how in the field of development through to commercial production at the Regensburg site, especially for highly potent active ingredients such as those used against cancer.
<h5>Now that the new ADAPTA 200 is on site in Regensburg, tell us which of its features you appreciate most?</h5>
Firstly, let me say that in keeping with the Aenova Group’s policy to adopt cutting-edge technologies, the choice landed easily with ADAPTA 200. We immediately recognised the value of a high-speed solution enabling full scalability and large production capacity. The compact footprint has allowed us to free up enough space to include further potential filling requirements, which fits perfectly with our objective for increased capsule filling capacity.
More specifically, we are extremely satisfied with the real speeds reached. An output of 200,000 capsules/hour is exactly what we needed and ADAPTA 200 consistently achieves these figures. Let me say that many times the declared speed is not the real speed, but in this case there is no difference.
Another aspect which has impressed us is the 100% in-process weight checking capability. Real time monitoring and measuring of capsule weight is handled by the system directly connected to the machine, giving us the peace of mind that key parameters are respected. Last but not least, despite the space-efficient size of ADAPTA, and even with different dose combinations, the high production speeds are maintained. Finally, it is equally important for us to underline the broader benefits we enjoy from a product landscape that IMA has installed at our Regensburg site. The ZANASI machines – in particular the 12 E and the AZ 5 – are perfectly sized either for small batches or for product development activities. Together with the larger ZANASI capsule filler and the latest-generation ADAPTA 200, we are well-placed today to deliver the most flexible response to all our customers. And in today’s market, that is vital.
<figure><img src="https://www.aenova-group.com/content/_medium/IMA-RGB-2.png" data-image="555683" alt="Neue Kapselfüllmaschine am high-potent Standort Regensburg"><figcaption>New capsule filling machine at the Aenova high-potent Regensburg site (Photos: Aenova)</figcaption></figure>

Aenova Christmas campaign: employees donate to social organisations

16/12/2022 - Aenova Christmas campaign:  employees donate to social organizations

Starnberg, 16/12/2022

Aenova employees collected donations in kind and money for social institutions in Starnberg at the beginning of December 2022. These donations will be used to support two organizations that help disadvantaged people.
The year 2022 is and was a challenging year worldwide. The Corona pandemic was followed by the Ukraine war. Energy supply, price increases and inflation have since affected many people and organizations, including in Germany. Disadvantaged and socially weaker people are particularly affected.Therefore, Aenova, a leading global contract developer and manufacturer for the pharmaceutical and healthcare industries, organized two donation initiatives as a Christmas campaign. At Aenova's headquarters in Starnberg, employees collected donations in kind and a sum of money for two local social institutions: Winter clothing and shoes for children and adults, toys, tableware and household goods. Both institutions are very grateful for the spontaneous donations, especially now in the cold season and with partly declining donations in recent months. "We are pleased that we can support people in need and the socially disadvantaged with our joint contributions. A big thank you to our employees who made these joint campaigns possible," explains Dr. Susanne Knabe, Head of Corporate Communication at Aenova. "In the coming year, we plan to expand these initiatives." As part of its corporate social responsibility strategy, the company, with its 16 sites worldwide, is primarily involved in the local environment and supports charitable initiatives at the individual company locations. There are social institutions that prefer to work in silence and do not want to be named. A separate information will follow on the presentation of the check for the cash donation.
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_STA_Weihnachtssachspende.jpg" data-image="555601" alt="Weihnachtsspende 2022"><figcaption>Aenova employees collected for charity at Christmas 2022. (Photo: Aenova)</figcaption></figure>

Münster

Training is important to us: Aenova Münster at CoeMBO 2022

06/12/2022 - Training is important to us: Aenova Münster at CoeMBO 2022

Münster, 06/12/2022

Training is of great importance at Aenova. With over 80 trainees within the Aenova Group, vocational training for the next generation is an integral part at all Aenova locations.At the career information fair CoeMBO on November 12, 2022 in the school center of the city of Coesfeld, Aenova Münster was on site with a team and informed many young interested students about all topics related to training at one of the world's leading contract manufacturers for the pharmaceutical and healthcare industry. Aenova's Münster site focuses on the development, production and packaging of high-potency and/or low-dose tablets and, in particular, hormones, hormone-like substances and narcotics. Another focus is on production technologies for micro-dosed capsules, e.g. with dry powder for inhalation. Around 250 employees contribute to the success of the site. The following training courses are offered: Apprenticeship as chemical laboratory assistant (m/f/d), pharmaceutical assistant (m/f/d), industrial clerk (m/f/d), IT specialist for system integration (m/f/d). Currently, 9 trainees are employed at Aenova in Münster. "We are pleased to be able to offer young people in the region interesting apprenticeships every year. The pharmaceutical industry is characterized by very good job and career prospects," explains Michael Obermeier, Head of Human Resources in Münster. "At the same time, we work here for the health of patients worldwide. That, of course, is another very special motivation," Obermeier continues. The CoeMBO is a trade fair for career guidance, where young people from Münsterland and the surrounding area get the opportunity to get an overview of the possibilities after graduating from school. After a two-year break from Corona, the fair was held again this year in presence. <figure><img src="https://www.aenova-group.com/content/_medium/Messe_Gruppenfoto-MST.jpg" data-image="555374"><figcaption>Team Aenova Münster at training event</figcaption></figure>

27.05.2020

27.05.2020

COVID-19: Start of Phase 2 clinical trial of IMU-838