Prioritize Safety And Mitigate Risk In HPAPI Manufacturing

By Dr. Karel Vervisch, Research And Development Manager, Ajinomoto Bio-Pharma Services

Highly potent active pharmaceutical ingredients (HPAPIs) continue to grow in the industry, with current growth figures at around 10.5% per year. As a result, there has been a proportional increase in HPAPI portfolios. Due to their high potency and cytotoxicity, proper containment and expertise around scale up are critical for safe HPAPI manufacturing. Handling these potent compounds requires significant attention to detail and technical knowledge to mitigate risk and maintain technician safety while producing a drug that fulfills customer expectations.

To ensure safety, consider working with a manufacturer who leverages a risk-based approach. A strategy like this starts with defining an Occupational Exposure Level (OEL) or classifying the product into an Occupational Exposure Banding (OEB). OELs and OEBs determine the maximum acceptable level of exposure for personnel, and thus the containment strategy to be used. To learn more about strategic containment mechanisms and the impact of well-trained HPAPI handlers, download the full whitepaper.