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 2026
- Publish article in ISCT Newsletter sharing industry best practice on Cryopreservation Click Here to Read
- Publish article in ISCT Newsletter Sharing Industry Best practice on Post Thaw Analytics in q1 2026
- Host a webinar on the topic of Cryoscaling in Q1 2026.
- Clinical Cold Chain Readiness Toolkit : Develop a comprehensive toolkit outlining best practices and infrastructure requirements for clinical sites establishing GMP compliance and administering CGTs. To address topics such as cryopreservation, storage, handling, and thawing.