Bridging Analytical Gaps To Ensure CGT Material Quality

In this segment of Cell & Gene Live, "Materials Matter: Ensuring Quality of CGT Materials," Cell & Gene Chief Editor Erin Harris was joined by Anthony Blaszczyk, Ph.D., Senior Scientist at the U.S. Pharmacopeia, and Basak Clements, Ph.D., Founder and Senior Advisor at biomatria, to discuss why analytical gaps remain a major challenge in cell and gene therapy. Current methods often can’t fully or consistently measure complex materials, leading to mismatched data, comparability issues, and potential development delays. They stressed why teams should align testing approaches with suppliers, invest in fit-for-purpose analytics early, and prioritize risk assessment and quality upfront to avoid costly downstream failures.