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White Papers / Tech Papers

Clinical Holds in Cell & Gene Therapies

Released By Solvias

Cell and gene therapies (CGTs) are revolutionizing treatment, but increasing regulatory scrutiny has led to a rise in costly clinical holds – especially around complex CMC and potency testing. Early potency assay development is critical to preventing delays and aligning with FDA expectations. This white paper explores the challenges of CGT potency assays and shows how starting early can reduce risk, improve quality, and streamline regulatory progress.

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