Handling Protocols: Key Considerations In The Highly Potent API Market

By Tom Hunter, Director of Process and Analytical Development, MilliporeSigma

Highly potent active pharmaceutical ingredients (HPAPIs) are compounds characterized by their ability to exert significant biological effects at extremely low concentrations. This potency makes them indispensable in the development of targeted therapies, especially in the field of oncology, where precision and efficacy are paramount. As the pharmaceutical industry increasingly turns to innovative treatment modalities such as Antibody-Drug Conjugates (ADCs), the demand for HPAPIs continues to rise. Engineering controls, such as closed systems and high-efficiency particulate air (HEPA) filtration, play a vital role in minimizing the risk of contamination and exposure. Dedicated facilities, often with segregated areas for different stages of production, further enhance safety and compliance with regulatory standards. For Contract Development and Manufacturing Organizations (CDMOs), the HPAPI market presents substantial growth opportunities. However, capitalizing on these opportunities requires significant investment in infrastructure, technology, and expertise to navigate the complex landscape of HPAPI production safely and effectively.

Delve into the intricacies of HPAPI manufacturing, with a particular focus on the unique challenges presented by the expanding ADC market in this whitepaper.