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 under this link.