08.09.22 -- Solving Bioassay Challenges For Cell & Gene Therapies

Recently, USP held a bioassay training workshop that included regulatory considerations, analytical validation, and case studies related to bioassays for cell and gene therapy products that are also used for potency. This article recaps the key insights from the workshop.

In the world of environmental monitoring in pharma manufacturing, it is common to rely on methods requiring media and subsequent incubation to detect microorganisms. For more extensive contamination events (e.g., mold occurrence), it is common to perform additional evaluations that can lead to extended downtime.