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Manufacturing & Analytical Characterization
Partner Presentation

Safe Handling of Potent APIs at CMOs, CDMOs, and CROs

Tuesday, November 11, 2025
11:00 AM - 12:00 PM CT
Location:360 Stage #2, Exhibit Hall

Sponsored By 
Manufacturing and Analytical Characterization Partner Presentation-Manufacturing & Bioprocessing

Description: As highly potent and targeted pharmaceuticals such as ADCs move from lab to market, CMOs, CDMOs, and CROs must balance worker protection and product safety. This session will highlight best practices for containment, controls, and procedures; illustrate examples of successes and failures in handling potent APIs; and outline systematic approaches for safety and quality. Guidance on quantitative assessments will be shared to ensure adequate containment and minimize occupational and cross-contamination risks.

Learning Objectives:

  • Identify essential hardware (containment/controls) and software (procedures/practices) for potent API safety.
  • Distinguish between organizations effectively managing potent APIs versus those falling short
  • Apply systematic and quantitative approaches to verify containment adequacy and minimize risk.