Cell Therapy Manufacturing: Testing, Validation & Regulatory Insights

▤ Summary

This article explains the manufacturing, testing, and validation challenges involved in cell and gene therapy development. It describes how sponsors must use compendial and product-specific analytical methods to support quality, safety, potency, and regulatory compliance. It also outlines the main control points across starting materials, raw materials, in-process testing, final product testing, and stability studies. The piece emphasizes that potency assay development and analytical validation become more demanding as programs move from early development toward commercialization. It closes by highlighting the need to align CMC strategy with FDA and ICH expectations.

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