Charter
The Cold Chain Management and Logistics Working Group of ISCT is working towards a long-term goal of developing and releasing an ISCT Best Practice document on the topic, relevant to both cell and gene therapies.
Goals
To gather a comprehensive set of industry perspectives, the group will develop a seven-part survey (including Primary Container Selection, Formulation, Cryopreservation, Storage and Shipping, Stability, Thawing, Post-Thaw Analytics) for broad distribution. Topics were defined from an industry response letter to the FDA in 2022 regarding the ‘Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products
Projects & Objectives
- Surveys: Create and release the seven-part survey and compile and present findings
- Presentations: At least one webinar developed in response to survey data covering a common industry pain-point
- Publications: Initiate the best practices document for introduction at ISCT Baltimore meeting.