Navigating cold chain complexity to enable clinical-to-commercial transition of advanced therapies

Cell and gene therapy (CGT) products often require ultracold temperatures for both manufacturing and distribution, which poses significant challenges, especially when transitioning from clinical to commercial stages. To maintain product integrity and manage complex global logistics, efficient supply chains, integrated end-to-end services, and compliance with evolving regulatory requirements are crucial. In this article, the benefits of leveraging a global network and innovative cold chain solutions to address these hurdles and ensure successful commercialization and global distribution of CGT products will be discussed. Specific aspects ranging from the implementation of precise temperature-controlled packaging to late-stage customization will be examined. Finally, an illustrative case study of the transition of a first-in-class allogeneic cell therapy from clinical to commercial stages will be shared.