<ul><li>Size of the site: 15,500 m² (total floor area) </li><li>Production: 3,506 m²</li><li>Packaging: 3,966 m² </li><li>Goods receipt and storage: 4,200 m² </li><li>Analytics: 877 m² </li><li>Formulation development/ clinical trials: 200 m² </li><li>FTE: 363 </li><li>Shifts: 15/5</li></ul>

<ul><li>Production of Solids<ul><li>Tablets</li><li>Powder and granules</li><li>Hardcapsules</li><li>Film coated tablets</li></ul></li><li>Semisolids<ul><li>Gels</li><li>Creams</li><li>Pastes</li><li>Ointments </li></ul></li><li>Non sterile Liquids<ul><li>Solutions</li><li>Suspensions</li></ul></li><li>OEB 1-5, incl. narcotics and hormones</li><li>Quality service</li></ul>

<ul><li>Handling of cytotoxic / cytostatic and high potent solid dosage forms</li><li>Fully cGMP compliant analytical and pharmaceutical development</li><li>Manufacture of clinical trial material and small-scale commercial production</li><li>Project management and corporate activities (e.g. RFQ, R&amp;D sales, IP &amp; portfolio management)</li><li>Technolgy transfer</li><li>Lifecycle management</li></ul>

<ul><li>Tablets (blister)</li><li>Tablets (bottles)</li><li>Liquids in bottles</li><li>Semisolids in bottles</li><li>Tubes</li><li>Dispensers</li><li>Integrated serialization &amp; aggregation</li></ul>

<ul><li>Manufacturing licenses<ul><li>EU GMP </li></ul></li><li>Non EU-GMP certificates<ul><li>US FDA </li><li>ANVISA </li><li>Belarusian Health Authority</li><li>Japanese FDA</li><li>Kenyan Health Authority</li><li>MFDS (Korea)</li><li>Russian MoH </li><li>FDA Saudi Arabia </li><li>Turkish MoH</li><li>Uganda MoH </li></ul></li></ul>

<ul><li>Rx</li><li>OTC</li><li>Food Supplements</li><li>COSM</li></ul>

Technologies

<ul><li>Equipment:<ul><li>7 tablet presses</li><li>5 capsule fillers (Hard Shell), different sizes and filling types</li><li>2 fluid bed granulators</li><li>6 drying ovens</li><li>4 roller compactors</li><li>4 large scale mixing &amp; homogenization vessels for SEL</li></ul></li></ul>
<ul><li>Coating<ul><li>3 film coating suites</li></ul></li><li>Packaging<ul><li>7 blister lines</li><li>5 bottle filling lines</li><li>5 filling lines for semisolids</li><li>2 filling lines for liquids</li></ul></li></ul>
<ul><li>Quality Control<ul><li>19 HPLC</li><li>5 Disso-tester</li><li>Franz-Zelle</li><li>2 RAMAN spectrometers</li><li>Own microbiological lab</li><li>several stabilities chamber</li></ul></li></ul>

Products

<ul><li>Anesthetics</li><li>Antidiarrheals, intestinal antiinflammatory / antiinfective agents</li><li>Antigout preparations</li><li>Anti-inflammatory and antirheumatic products</li><li>Antineoplastic agents</li><li>Anti-parkinson drugs</li><li>Antiprotozoals</li><li>Cardiac therapy</li><li>Corticosteroids for systemic use</li><li>Corticosteroids for topical use</li><li>Cytostatics / Cytotoxics</li><li>Digestives, including enzymes</li><li>Diuretics</li><li>Drugs for acid related disorders</li><li>Drugs for functional gastrointestinal disorders</li><li>Emollients and protectives</li><li>Endocrine therapy</li><li>Gynecological antiinfectives and antiseptics</li><li>Immunosuppressants</li><li>Preparations for treatment of wounds and ulcers</li><li>Psycholeptics</li><li>Sex hormones and modulators of the genital system</li><li>Stomatological preparations</li></ul>

Regensburg

The Aenova Group site in Regensburg with its special environment is one of the leading HPAPI development, production and packaging facilities for high potent solids.

The Aenova site in Regensburg has special expertise in the field of customized development, production and packaging of highly potent...

Regensburg - Aenova Group

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Aenova Site Regensburg High-potent APIs

Facts

Location Regensburg, Germany 
Competence Center high potent solids (oncology) – conventional solids - specialty semisolids & liquids

The Aenova Group site in Regensburg with its special environment is one of the leading HPAPI development, production and packaging facilities for high potent solids: 

<ul><li>Capsules, tablets and film coated tablets</li><li>From small to large scale (0,5 to 500kg)</li><li> Covering complete lifecyle from development to commercial supply for Capsules, Tablets & Film Coated Tablets</li></ul>
The Aenova site in Regensburg is a state-of-the-art facility paired with high flexibility.
Strategic expansions will enable the site´s production capacity to double within the next years. This strategic expansion took place in 2023 to enable the site‘s production capacity for HPAPI to double within the next years and to offer tailor-made/ plant-in-plant solutions for customers.

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>

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>

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>

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 Regensburg at "Nacht schafft Wissen"

11/10/2022 - Aenova Regensburg at "Nacht schafft Wissen"

Regensburg, 11/10/2022

"Nacht schafft Wissen" (Night Creates Knowledge) is a format that is now well established in Regensburg to bring "Innovations made in Regensburg" closer to the people. The event focuses on research, science and development and offers an evening-long look behind the scenes of Regensburg companies and universities. The numerous organizers have put together an exciting, educational and entertaining program.
The Aenova site in Regensburg is already one of the long-standing supporters of this event. At Aenova's Regensburg site, approximately 420 employees work in the laboratory, in analytics, production or packaging. The strategic focus is on the production of tablets or capsules used in cancer therapy.
<h5>Program points of the evening at Aenova in Regensburg:</h5>
<ul><li>Guided tour: production of highly potent drugs in the clean room.</li><li>Analytical laboratory - In search of the active ingredient in the tablet</li><li>Haupt Pharma Amareg, Member of the Aenova Group, as employer and training company</li><li>Exhibition: Pharmaceutical production in Regensburg</li></ul>
Regensburg: 21 October 2022, 17:00 to 23:00
For further information please visit the <a href="https://www.nacht-schafft-wissen.de/" target="_blank">website "Nacht schafft Wissen"</a>. We look forward to seeing you there!

<figure><img src="https://www.aenova-group.com/content/_portrait/554917/Aenova_RGB_NachtschafftWissen_Posting-3.jpg" data-image="554917" alt="Regensburg Nacht schafft Wissen"><figcaption>Test demonstration at the Aenova site at "Nacht schafft Wissen" (Night creates knowledge)</figcaption></figure>
Header graphic: @Stadtmarketing Regensburg

Aenova invests in new building for the production of highly potent drugs

08/04/2022 - Aenova invests in new building for the production of highly potent drugs

Regensburg, 08/04/2022

Aenova has laid the foundation for the new building for highly potent active ingredients at its Regensburg site. Highly potent drugs, especially against cancer, are produced in the new manufacturing facilities. With an investment of around 10 million euros, Aenova will thus be able to significantly increase production capacity to meet increased market demand.
Cytotoxics and cytostatics continue to experience increased demand in the global pharmaceutical market. To meet this growing demand, Aenova, global leading development service provider and contract manufacturer for the pharmaceutical and healthcare industries, is building a new facility at its Regensburg site. The investment of around €10 million will enable the company to significantly expand the production in the field of highly potent active ingredients and, in particular, cancer drugs. The foundation slab for the new building was poured in March 2022.
The Aenova site in Regensburg has been developing and producing tablets and capsules with highly potent active ingredients such as methotrexate, hydroxycarbamide, azathioprine, imatinib on the former von Heyden site since the 1950s. The new four-story building with a total building area of over 4,000 m² will include not only bulk production and packaging of highly potent drugs, but also the associated laboratories, development, warehouses and social rooms. This not only means a significant expansion of the production area and the so-called white areas of development and laboratory to over 300 m² at the Regensburg site. After the planned start of operations at the beginning of 2023, the manufacturing capacities can thus be increased in volume by significantly more than 1 billion tablets and capsules. An entire floor is also reserved for flexible customer requests for "on demand" production, so that existing as well as new customers can be individually supported in line with their requests. "With this expansion, we are achieving our goal of strengthening the Regensburg site as the "Competence Center HPAPI & Oncology Products" within the Aenova Group," explains Oliver Schmied, Managing Director at the Aenova site in Regensburg. "After all, this will not only enable us to better serve market needs and customer requests, but above all to reliably provide essential medicines for patients suffering from cancer worldwide."
"Within the overall investments of the Aenova Group, the new building for highly potent active ingredients in Regensburg is an essential 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 Jan Kengelbach, CEO of Aenova Group. The new building is scheduled for completion in summer 2022 and occupation in fall 2022. This will be followed by the installation of the laboratories and the new "on-demand" GMP area. Additional customer orders can be produced from 2023.
<figure><img src="https://www.aenova-group.com/content/navigation/_medium/Aenova_New_Building_RGB_Sketch.jpg" data-image="545856" alt="New Building high potent drugs Regensburg"><figcaption>Sketch of the new building at the Aenova site in Regensburg for the production of highly potent drugs (Sketch: Immo GmbH).</figcaption></figure>

PM Aenova RGB New Press EN vf HP

Aenova increases capacity for tablet production in the area of highly potent, hormone-containing active ingredients

02/02/2021 - Aenova increases capacity at Regensburg site to almost 1m. tablets per hour

Regensburg, 02.02.2021

Aenova expands production of highly potent oncology drugs (up to OEB 5) with new tablet press. The fully automatic, online and process integrated control significantly increases process efficiency and enhances safety and product quality. This will enable the output of tablets for cytostatics, immunosuppressants and hormone-containing preparations at the Regensburg site to be increased to almost 1 million tablets per hour.

In COVID-19 times: Haupt Pharma Amareg produces disinfectant for
the city of Regensburg

In COVID-19 times: Haupt Pharma Amareg produces disinfectant for the city of Regensburg

Regensburg, 03.06.2020

Haupt Pharma Amareg GmbH, a member of the Aenova Group, has been supporting the city of Regensburg with disinfectants since the beginning of the Corona crisis. Since March 2020, 12,000 liters have already been delivered.

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