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How to select the ideal HPAPI manufacturing partner

May 21, 2024
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The article discusses the challenges and strategies associated with safely manufacturing highly potent active pharmaceutical ingredients (HPAPIs). HPAPIs offer therapeutic benefits but pose risks to manufacturing personnel due to their potency. To ensure safety, manufacturers must employ containment measures and high-quality equipment. Occupational exposure banding (OEB) systems categorize the risk level of HPAPIs, guiding containment, process analytical techniques (PATs), and personal protective equipment (PPE) usage. Effective HPAPI handling involves training employees, establishing containment protocols, and implementing safety measures such as atmospheric monitoring and task risk analysis. Analytical techniques like near infrared (NIR) spectroscopy and Fourier-transform infrared (FTIR) spectroscopy aid in monitoring HPAPI processes. Choosing the right contract development and manufacturing organization (CDMO) involves assessing their experience, containment methods, analytical capabilities, and safety protocols. Partnering with a CDMO that prioritizes safety, offers customized solutions, and demonstrates expertise in HPAPI manufacturing ensures efficient and quality production for patient use.

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