Cell Transportation Standard Published
We are pleased to announce that another SCB-coordinated standard project has culminated in the publication of a standard. ISO 21973: General requirements for transportation of cells for therapeutic use was published in June 2020 and is now available for purchase.
Transportation of cells is a common pain point for regenerative medicine product developers as they seek to bring products to market. The regenerative medicine supply chain is complex, with products passing between many different stakeholders before they reach patients. Well-established requirements for procedures during transport are necessary to ensure product efficacy and safety. To meet this need, ISO 21973 establishes minimum requirements for:
IT infrastructure
Chain-of-custody systems
Centralized logistics management systems
Transportation protocols
Shipment tracking
Shipment monitoring
Standard Development Process
This standard effort built on the initial work of the ISO/TC 276 Japanese Mirror Committee to generate definitions and general requirements for cell transportation, an effort that began in 2014. SCB joined the effort in 2016, forming a working group with more than 20 experts from government institutions, membership organizations, and industry organizations to identify additional gaps and needs for cell transportation standards.
The U.S. and Japanese working groups collaborated to draft and combine two documentary standards that incorporated the perspectives of both cell therapy suppliers and users. After multiple rounds of revision to ensure clarity and capture broad perspectives from stakeholders in the regenerative medicine community, the standard was published.
Industry Impact
The standard addresses a key crosscutting need for consistent practices among stakeholders that transport, handle, and store regenerative medicine products. Because transportation is critical to scaling regenerative medicine product development operations and bringing products to market, we believe this standard will make a significant impact on the growth of the industry across all sectors. The standard has the potential to save product developers time, effort, and guesswork in establishing transportation plans for their products by providing a clear-cut framework to enable more efficient, cost-effective transportation operations and improved product quality and safety.
Get Involved
To join an SCB-coordinated standards project or learn about other ways you can contribute to regenerative medicine standards development, contact SCB or join a sector working group.