Five Best Practices To Adapt And Improve Quality Control Programs For CGTs

Launching a successful GMP program for biologics hinges on a robust quality control (QC) release testing protocol. This testing, mandated by global regulatory bodies, safeguards patients by verifying that biologic products meet scientific specifications. While individual programs may have nuances, core QC testing gathers data to answer critical questions about a biologic, including identity confirmation, purity evaluation, potency determination, and product quality attribute verifications.

The landscape of biologics is expanding beyond traditional monoclonal antibodies (mAbs) and recombinant proteins, to encompass innovative cell and gene therapies. As a result, QC programs must evolve to address the unique challenges presented by these novel therapeutics. Intrigued? Download the full article to learn more.