How To Overcome Potency Assay Development Challenges For Gene Therapies
Published in: Cell & Gene
Published on: April 22, 2022
Potency is one of the CQAs for GT development and manufacturing that is most related to the therapeutic product’s mechanism of action (MoA). However, developing and validating appropriate potency assays that reflect the MoA acceptable to regulators is a process fraught with challenges.
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