04.10.2024

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.