Implement A Risk-Based Approach To Safely Manufacture HPAPIs

Highly potent active pharmaceutical ingredients (HPAPIs) are becoming increasingly appealing as therapeutic vehicles for a number of indications, including cancer. As drug manufacturers look to start producing HPAPIs with higher frequency, they must also consider the obstacles associated with scaling these highly potent chemicals. Some leaders in the industry are opting to implement risk-based approaches that leverage occupational exposure banding (OEB) assessments to designate how much exposure to an HPAPI is acceptable for personnel, known as the occupational exposure limit (OEL). OEB protocols can help companies build stronger, more effective containment strategies to protect employees.

In a recent webinar hosted by Ajinomoto Bio-Pharma Services, Karel Vervisch, Manager of Research and Development, provided his expert insight into how to implement a risk-based OEB strategy across an HPAPI manufacturing life cycle. Download the full article to read webinar attendee questions and Vervisch’s answers on Aji Bio-Pharma’s in-house workflows for handling different OEB levels and reducing risk.