Key CMC and NC considerations for cell and gene therapy development

Published on: Jul 3rd, 2023

ATMPs (Advanced Therapeutic Medicinal Products) in Europe, or CGTs (Cell and Gene Therapies) as they are known in the US, represent the fastest growing arena in today’s global biotechnology and biopharmaceutical sectors. Despite a slow start, there were at the end of Q1 2023 approximately 20 cell and gene therapies (CGTs) based on viral vectors approved in the EU/US, and the tendency for the future is towards exponential developments. Regardless of region, such innovative products face specific challenging CMC and nonclinical hurdles which were reviewed and regrouped as part of a benchmark approach considering approved CGTs.

In this webinar, VCLS regulatory science experts analyzed the global cell and gene therapy development landscape, NC and CMC related challenges in regard of developing this type of products and the resulting trends and tendencies.