The advanced therapy supply chain is complex and made up of multiple moving parts. With milestone achievements such as the recent FDA approval of Novartis' CAR-T cell therapy Kymriah™ it's essential that we address the challenges of delivering these ground breaking therapies to patients on a global scale.

Population-based biobanking is an essential aspect of biomedical research. When biobank samples are collected outside of clinical or research facilities, chances for variation in sample collection, handling, and shipping increase. Any lack of standardization before, during, or after collections can generate unwanted pre-analytical variability that hurts future use of biospecimens.

As discussed by Sarah Hand on the xTalks blog, cell therapy and immunotherapy clinical trials present unique challenges to CROs and clinical sites, including patient safety considerations and complex mechanisms of action. Among the most important components to a successful cell therapy clinical trial is the necessity of controlling the environmental conditions to which the biological product is exposed.

The cell therapy clinical trial supply chain can be complex, especially if the study involves multiple international sites. To understand how sponsors can reduce risk and position their product well for commercialization, Sarah Hand sat down with us to discuss the complexity associated with the cell therapy supply chain and maintaining cryogenic temperatures.

To learn more please download our webinar, Cell Therapy: Achieving Success on the Road to Commercialization, at the end of this blog.