Why assay development cannot wait: reference standards, potency testing, and the move away from animal models

“Establishing potency testing for CGT products, particularly cell-based ones, requires an iterative approach throughout product development”

Wil Rich (Editor, BioInsights) speaks with Scott Burger (Principal, Advanced Cell and Gene Therapy and Bill Janssen (Principal, WEJ Cell and Gene Therapy Consulting Services) about analytical strategy for cell and gene therapies, including how to define comparability when the starting material is variable by nature, phase-appropriate assay and potency development, bridging assay changes, reference materials for decentralized manufacturing, and the move away from animal models.

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