Handling Potent Active Pharmaceutical Ingredients (APIs) Safely to Protect Workers and for Product Protection – Lessons Learned From the Scientific Evaluation of Contract Manufacturing Organizations (CMOs) in the Pharmaceutical Industry | CPhI North America

 

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Handling Potent Active Pharmaceutical Ingredients (APIs) Safely to Protect Workers and for Product Protection – Lessons Learned From the Scientific Evaluation of Contract Manufacturing Organizations (CMOs) in the Pharmaceutical Industry

Allan W. Ader, Ph.D. (Managing Director, SafeBridge Consultants, Inc.)

Location: Exhibitor Showcase Theater

Date: Tuesday, April 30

Time: 12:30pm - 12:55pm

Track: Exhibitor Showcase

Vault Recording: TBD

As more highly potent and targeted pharmaceuticals make their way from the research laboratory to the marketplace, a systematic and scientific multi-faceted approach is necessary to reduce occupational health risk and minimize product cross-contamination. Contract manufacturing organizations (CMOs) are an increasing part of the equation, as they have become the majority provider of these compounds to the marketplace. Within the CMO space, there are the “contenders”, those CMOs who understand both the hardware (containment and controls) and software (procedures, practices and programs) and the “pretenders”, those who believe they can safely handle these compounds, but don’t have the appropriate elements and systematic programs in place. This presentation will provide examples of what can go right and what can go wrong when taking on projects with potent APIs and drug products. It will also describe requirements and elements of a scientific and systematic program to support potent compound safety and quality assurance programs with potent APIs at CMOs and drug innovators, and guidance on quantitative assessments needed to verify the adequacy of containment, controls and work practices for the safety of workers and also for patients taking these vital therapies.