The cell and gene therapy market is about to reach a commercialization inflection point, with the FDA anticipating 10-20 new approvals per year through 2025¹. As innovators approach their commercial filing, it is vital to consider how the drug will be packaged, labeled, and distributed to hospital sites. Many questions regarding courier services or tertiary packaging and data loggers are addressed in clinical trials. However, the standards for commercial drug product are very specific, and your filing will need to demonstrate validated processes for every aspect of your logistics strategy, from labeling to shipping.
Discover how Patheon leverages 35+ years of experience and a global network to support the secondary packaging, labeling, and distribution of your life-saving cell or gene therapy.