Author Archives: Zeb Younes

Manufacture and Regulation of Cell, Gene, and Tissue Therapies, Part 1: Chemistry, Manufacturing, and Control Challenges

Cell, gene, and tissue (CGT) therapies and other advanced-therapy medicinal products (ATMPs) have made tremendous progress over the past decade. They are different from other biologics and small molecules because of their inherent complexity and variability. Although many unknowns remain about the development of these products, their clinical success has enabled the CGT therapy and ATMP fields to advance rapidly. We are seeing an increase in the number of marketing authorization applications (MAAs) filed in the European Union and new…