How To Select The Ideal HPAPI Manufacturing Partner

By Karel Vervisch, Ph.D., Research and Development Manager, Ajinomoto Bio-Pharma Services

Highly potent active pharmaceutical ingredients (HPAPIs) now account for a major portion of the drug development pipeline, thanks to benefits including innovative therapeutic potential, reduced side effects, and high specificity. However, their potency poses risks to manufacturing personnel throughout the bench to commercial scale-up process. To ensure safety during HPAPI production, manufacturers must have the knowledge to effectively use containment and design high-quality equipment. As drug companies seek the most compatible HPAPI manufacturing partner to meet their goals, it is critical to understand the offerings synonymous with ample experience and safety expertise to ensure efficient timelines.

Safely manufacturing HPAPIs begins by employing an occupational exposure banding (OEB) system to designate the risk associated with a specific product. From there, containment, process analytical tools (PATs), and personal protective equipment (PPE) are leveraged according to proven protocols associated with each band. An adept contract development and manufacturing organization (CDMO) will plan a process and equipment setup to safely and efficiently manufacture your HPAPI at-scale. Download the full article to learn the key attributes of an experienced and knowledgeable HPAPI manufacturing partner.