Safety, containment, and analysis of highly potent compounds from development to commercialization

Safety, containment, and analysis of highly potent compounds from development to commercialization

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Overview

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

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