Enabling Advanced Therapies by Solving CMC Challenges: A Quality Control Solution

The evolution of the therapeutic landscape towards cell and gene therapy (CGT) products heralds immense potential for patients. According to the American Society of Gene and Cell Therapy (ASGCT), there are now more than 100 gene and cell therapies approved globally for commercial use, including 32 gene therapies, 28 RNA therapies, and 68 non-genetically modified cell therapies1. Even more promisingly, more than 4,000 gene, cell, and RNA therapies are in development, with at least 11% already in Phase I clinical programs.

It is widely acknowledged that the complexity of CGT drug products’ composition and production, coupled with the rapidly evolving technological landscape of the field, necessitates rapid manufacturing changes during the drug development lifecycle. These new challenges, and the need for faster turnaround time for process changes, underscore the necessity of innovative CMC models.

Download our latest whitepaper to learn more about CMC challenges in ATMP manufacturing, as well as strategies to combat them.