What is ISO 21973 about?
ISO 21973 discusses the transportation of cells for therapeutic use for Biotechnology. ISO 21973 specifies general requirements and reviews the points to consider for the transportation of cells for therapeutic use, including storage during transportation.
Transportation starts from the transfer of the packaged cells by the sender to the transportation service provider and ends when the package is delivered to the receiver at its destination.
ISO 21973 includes the development of a transportation plan including verification and validation, communication between the client and the transportation service provider, and associated documentation.
Note 1: ISO 21973 does not apply to the transportation of cells within one facility
Note 2: ISO 21973 does not specify conditions for transportation such as specification for a shipping container, ambient temperature control, etc.
Who is ISO 21973 for?
ISO 21973 on transportation of cells for therapeutic use for Biotechnology is useful for:
- Manufacturers of biotechnologies
- Test centers for biotechnologies
- Regulatory authorities
Why should you use ISO 21973?
Cells for therapeutic use provide potential cures for the most challenging disease conditions. However, in contrast to the unprecedented clinical benefits, managing the production and logistics of cells for therapeutic use proves to be challenging.
Not only is the cost exceedingly high to produce and transport these products, but the concerns over product safety and efficacy due to potential manufacturing or transportation deficiencies have also started mounting as more products are being developed and tested.
ISO 21973 guideline provides general concepts, cell transportation specification, best practices for shipping containers, labelling, operation, organization, storage facility, and document information for transportation of cells for therapeutic use for Biotechnology.
ISO 21973 helps in improving workflow and ensures cell quality, safety, and efficacy during the transportation process.
