• Bulletproof Your Supply Chain: Hope For The Best, Prepare For The Worst

    Explore how to incorporate flexibility in planning to overcome potential challenges, the value of having a contingency plan, and how to use a risk-based approach to determine where a contingency plan is needed.

  • New, LN2-Free Solution For Cryogenic Transport Of ATMPs

    Administration of cell therapies, in clinical trials or as commercial products, involves complex logistics between sometimes numerous partners and sites, making timing critical. A better understanding of the boundaries not to be crossed, in terms of transit time and temperature, to maintain cell integrity post-thaw, is studied here.

  • Cold Chain Logistics For Cell Therapy Production – A Conversation With Celyad’s Thomas Lequertier

    Because cell therapies must be stored and shipped at very low temperatures, maintaining a therapeutic’s integrity through cryopreservation has far-reaching implications for both its efficacy and long-term commercial success. Thomas Lequertier, head of the Cell Therapy Manufacturing Unit at Celyad Oncology, recently sat down with the Business of Biotech podcast to discuss how his company has approached cold chain technology for its CAR-T therapies.

  • Qualification Summary: Shippers For Celsius® FFT | FFTp 12L With Safecore™ Technology

    Since it is not possible to anticipate every possible transport route, a set of industry-recognized tests was selected to represent a challenging use scenario. The two main risks to frozen material during transport are mechanical and thermal. In this note we have evaluated the  Celsius® FFT | FFTp Box Shipper and Celsius® FFT | FFTp Bulk Shipper using the ASTM D-4169 test for mechanical risks and the ISTA 7D test for thermal risks.

  • Shipping Temperatures For Cell Therapies

    Cryopreserved cells are often stored at a central facility before being shipped to the clinical location. This study explores the required shipping and storage temperatures for cryogenic cold chain delivery of biological samples.