Strategies For The Development And Manufacture Of Highly Potent Compounds

By Catherine Wilkes, Executive Director, Environmental, Health and Safety, Compliance, and Robert Alfred, Director, Environmental, Health & Safety (EHS), Quotient Sciences

High-potency active pharmaceutical ingredients (HPAPIs) are becoming increasingly common in drug development pipelines. This is especially the case in the oncology sector as researchers look for therapies with greater selectivity and pharmacological activity. However, HPAPIs present additional chemistry, manufacturing, and controls (CMC) challenges due to the containment required to protect both operators and manufacturing facilities. Production processes may also require greater precision and control due to the very small quantities of drug present in the final dosage form. For drug developers, working with a contract development and manufacturing organization (CDMO) that has a long track record of successfully handling HPAPIs is essential.

This article discusses why it is important to classify HPAPIs and how they are evaluated, how HPAPI facilities are qualified, and strategies to ensure containment and safety when handling HPAPIs.