Addressing the Recent ISO 21973 Guidance: Considerations for Cell and Gene Therapy Distribution
Originally Hosted: Thursday, October 1, 2020
Duration: 30 Minutes
Cryoport’s Robert Jones, Vice President of Global BioServices, hosted an informational webinar about the newly released ISO 21973 guidance for cell and gene therapy distribution.
The International Organization for Standardization (ISO) has recently issued its eagerly awaited guidance on the transportation of cell for therapeutic use (ISO 21973). The ISO document is meant to provide general requirements and points to consider for transportation service providers, clients and senders to ensure cell quality, safety and efficacy during the transportation process. This webinar discusses the key recommendations and changes that interested parties should review and evaluate when planning their clinical and commercial distribution strategies for cell and gene therapies. Some of the elements discussed are documentation, traceability, validation and qualification activities, temporary storage, as well as cleaning and disinfection.