Safety, Containment, And Analysis Of Highly Potent Compounds From Development To Commercialization

By Brian Haney, Director, Technical Operations, and Iain MacGilp, Senior Director, GMP Production, Curia

This white paper provides a comprehensive overview of the challenges and requirements associated with working with highly potent compounds in drug development and manufacturing, emphasizing the need for stringent processes, specialized equipment, and robust capabilities in chemical synthesis, purification, and analysis to ensure containment, operator safety, and minimize the risk of cross-contamination.

Due to the challenges related to containment, safety, and cost-effectiveness, many pharmaceutical companies outsource the handling of HPAPIs to CDMOs with the necessary expertise and dedicated facilities. HPAPIs are classified based on their occupational exposure limit (OEL), which helps manufacturers determine the level of containment required for handling HPAPIs.

Explore the use of isolators and single-use containment systems in the manufacturing of HPAPIs. Isolators are used to process HPAPIs and can be attached to processing equipment for larger batches. Single-use containment systems are well-suited for multi-product facilities and eliminate the need for cleaning verification. Analytical services are also highlighted as important for detecting and quantifying HPAPIs and assessing impurities.