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.
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