Project: General considerations and requirements for cryopreservation processes for cellular therapeutic materials
TYPE: STANDARDS ADVANCEMENT PROJECT
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DESCRIPTION:
Cryopreservation processes are vital for many biotechnology and biomedical R&D and cell product manufacturing processes, including the stable transfer of starting, or finished cellular products at the required level of quality. The process of cryopreservation as well as the transfer and storage of cryopreserved materials is complex and may require separate stakeholder groups that will benefit from streamlined SOPs as well as product and process knowledge sharing.
An SCB coordinated working group is seeking to develop a single horizontal ISO consensus based standard covering cryopreservation process development for cellular therapeutic materials and effective implementation through operational aspects, logistics and quality control.
Progress:
(learn more about the standards advancement process)
Note: Projected start dates are estimates only. Development of a standard depends on SDO timelines, which can vary.
Assembled a Working Group: SCB initiated working group meetings in January 2024 to coordinate the standard advancement effort. The working group are developing a scope and outline draft for submission as a preliminary work item in Working Group 4 (Bioprocessing) if ISO/TC276 Biotechnology following successful balloting through ANSI.
GET ENGAGED:
SCB needs subject matter experts like you to join the working group — contact SCB.