C&EN White Paper
Safety, containment, and analysis of highly potent compounds from development to commercialization
Brought to you by Curia Global

Innovations in drug development, including an enhanced focus on targeted therapeutics and advanced screening methods, have led to an increase in the number of highly potent APIs (HPAPIs); in turn, this can deliver drugs requiring lower doses with fewer side effects. But safely working with these compounds during development and manufacturing can be a challenge, requiring stringent processes and specialized, qualified equipment to ensure containment, provide operator safety, and minimize risk of cross-contamination. The facilities working with HPAPIs need to have robust capabilities in chemical synthesis, purification, and analysis to properly support these drug product programs.

Key Objectives:

  • Development, manufacturing and analytical capabilities required to produce highly potent compounds
  • Containment strategy to ensure safety, quality, and to prevent cross-contamination
  • Importance of a potent compound certification to ensure a CDMO is prepared to handle, characterize, and contain HPAPIs
  • Benefits of partnering with a CDMO with end-to-end services, from process development to commercialization, which has the expertise and dedicated facilities to safely manage highly potent products

Brought to you by:
Curia Global
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