Knowledge Center

Do you want to gain insights into practical strategies for successfully scaling cell and gene therapies that focus on reproducibility, continuity, and cost control? Watch this webinar to learn how early-stage process optimization directly impacts manufacturing consistency and yield, and how digital systems can be applied to streamline document management, ensure GMP compliance, and improve process efficiency.

Chimeric antigen receptor (CAR)-T cell therapy is a revolutionary method that has emerged as a cutting-edge cancer treatment, harnessing the patient's T cells to bolster their immune system's anti-cancer capabilities. Traditionally, CAR-T cell production has relied on viral vectors, which present safety concerns, high costs, and production challenges. The investigation and development of alternative gene delivery systems are unlocking new possibilities.

Advanced Therapy Medicinal Products (ATMPs) are revolutionizing the treatment of a wide range of severe diseases. Their potential to deliver long-lasting or even curative effects places them at the forefront of biomedical innovation. However, despite their clinical promise, the successful development and widespread adoption of ATMPs face two critical hurdles: high manufacturing costs and market access specificities.

In this article, we will review some of the key challenges for product characterization and monitoring, and how physicochemical methods, when applicable, can leverage cell and gene therapy manufacturing.