Critical Considerations for the Manufacture of Highly Potent Compounds


The demand for highly potent active pharmaceutical ingredients (HPAPIs) has been increasing over the past decade, mainly driven by oncology research.

In this issue, we examine the intricacies of manufacturing HPAPIs and associated drug products, including a review of the relevant guidance, classification systems, and safety processes. We also explore how CDMO facilities, equipment, and procedures for HPAPIs should be adapted to ensure safety, compliance with GMP regulations, and the successful manufacture of your product.


Related resources that may interest you:

Webpage: High Potency Manufacturing Services
Webinar: Nanosuspension Formulations for Poorly Soluble Drugs
Interview: Handling Your Highly Potent APIs and Controlled Substances