Project: Transportation Requirements of Cells for Therapeutic Use
Type: Standards Advancement Project
Partners: ISO/TC 276 U.S. Working Group 4 (US WG4), ISO/TC 276 Japanese MirroR Committee, National Institute of Standards and Technology (NIST), and The SCB Cell Therapy and Tissue Engineering SECTOR Working Groups
Get Involved:Standard published: additional needs TBD
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Description:
The consistent and precise handling and storage of cell therapies during distribution is integral to the effectiveness of final products. Contamination, environmental changes, tracking discrepancies, and other inconsistencies during transport can compromise the integrity of the product and its safety and efficacy when delivered to a patient. Defining minimum requirements for transportation is the first step toward standardizing this critical stage in product distribution to ensure the quality and reliability of cell therapies.
Building on efforts of the ISO group from Japan to generate definitions and general requirements for cell transportation, SCB coordinated the U.S. effort to address cell transportation challenges from the perspectives of cell therapy product suppliers and transportation and logistics companies.
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.
Convened Experts: SCB formed a working group in October 2016 with more than 20 experts from government institutions, membership organizations, and industry organizations to identify gaps and needs for cell transportation standards.
Drafted and Combined Two Documentary Standards: SCB coordinated the drafting of a combined standard—incorporating perspectives from cell therapy suppliers and users—to define minimum requirements for regenerative medicine IT infrastructure, chain-of-custody systems, and centralized logistics management systems, and protocols for transportation, shipment tracking, and monitoring.
Presented Drafts to ISO/TC 276: The first drafts of this standard were submitted for discussion at the June 2018 ISO/TC 276 meeting.
Finalized Draft: The Japanese Mirror Committee edited the draft standard,and it underwent several rounds of comment and revision. The standard was published in June 2020 (ISO 21973: General requirements for transportation of cells for therapeutic use).
Get Engaged:
To learn more about this initiative, please contact SCB.