Implement a risk-based approach to safely manufacture HPAPIs

June 06, 2024

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Highly potent active pharmaceutical ingredients (HPAPIs) are increasingly used for therapeutic purposes, especially in cancer treatment. As drug manufacturers ramp up HPAPI production, they face challenges in scaling these potent chemicals. Many in the industry are adopting risk-based approaches using occupational exposure banding (OEB) assessments to determine acceptable exposure levels for personnel, known as occupational exposure limits (OEL). These OEB protocols help companies develop effective containment strategies to protect employees.

Karel Vervisch from Ajinomoto Bio-Pharma Services shared insights during a recent webinar on implementing risk-based OEB strategies for HPAPI manufacturing. Vervisch discussed the company's extensive experience with continuous flow processes for HPAPIs, which enhances control over hazardous reactions. They classify reactions by hazard level and often use continuous flow for the highest hazards.

In terms of design, Ajinomoto Bio-Pharma employs closed conditions and compartmentalization, including airlocks and pressure control, to manage different OEB levels. They also have specialized milling equipment for handling OEB5-level substances safely. While they sometimes run OEB3 products on OEB5 equipment with thorough cleaning, they never use OEB5 equipment for lower OEB levels to ensure safety and compliance.