Why Material Definitions Matter In Cell & Gene Therapy

In this first segment of Cell & Gene Live, Anthony Blaszczyk, Ph.D., Senior Scientist at the U.S. Pharmacopeia, and Basak Clements, Ph.D., Founder and Senior Advisor at biomatria, were joined by Cell & Gene Chief Editor Erin Harris to discuss why cell and gene therapy, clearly defining raw, starting, and ancillary materials, and using those terms consistently, is critical. Each category drives different risk levels, testing requirements, and regulatory expectations. The experts explained why misclassification or poor alignment on these definitions can lead to weak control strategies, quality issues, and regulatory challenges later in development.