Solving Particulates and Material Variability in CGT Manufacturing

Particulates and raw material variability remain two of the toughest, most talked about hurdles in cell and gene therapy.

In the upcoming 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, join Cell & Gene Chief Editor Erin Harris to examine industry efforts to establish meaningful standards for particulate control (both visible and subvisible) across CGT products.

The discussion will address the limitations of current testing methods and the need for a holistic, risk-based approach that manages particulates from raw materials through final product. We will also explore how variability drives batch failures and CMC delays, and how emerging digital QC systems and earlier supplier partnerships are helping organizations reduce these risks.