Aenova Expands High-Potency Development & Manufacturing Capabilities

In Regensburg, Germany, Aenova Group (stands 5A41 & 5F39) has significantly expanded its capabilities for the development and manufacturing of high-potent medicines. The investment aims to address the growing demand for highly potent active pharmaceutical ingredients (HPAPIs), which are used more frequently in treatments for cancers and autoimmune diseases. The upgraded facility will handle a broader range of manufacturing scales, ensuring high standards of quality and safety for high-potency drug production.

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.

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