Critical Considerations For The Safe And Compliant Manufacture Of Highly Potent Drugs

The escalating demand for highly potent active pharmaceutical ingredients (HPAPIs), particularly in the realm of oncology research, has surged in the past decade. Projections indicate that the HPAPI market will soar to $31.5 billion by 2029, with over 25% of existing drugs incorporating HPAPI formulations. This necessitates meticulous attention to manufacturing processes to ensure compliance with Good Manufacturing Practice (GMP) regulations for regulatory submissions. Furthermore, safeguarding the well-being of Contract Development and Manufacturing Organization (CDMO) operators and related personnel from exposure risks is paramount.

In this comprehensive exploration, we address the complexities inherent in HPAPI manufacturing, encompassing an examination of relevant guidance, classification systems, and safety protocols. Emphasis is placed on the imperative need to mitigate cross-contamination risks with other products. Additionally, the e-book underscores the significance of adhering to timelines and budgets for sponsors, shedding light on the critical role that carefully developed equipment, processes, and expertise play in the successful production of HPAPIs and associated drug products. The discussion extends to the adaptation of CDMO facilities, equipment, and processes tailored to optimize safety and success in diverse development projects.