ISO/NP 25950

Biotechnology — General considerations and requirements for cryopreservation processes for cellular therapeutic materials

Scope

This document provides requirements for the development and implementation of cryopreservation processes that support the quality of cellular therapeutic materials, between collection and point of use, as starting material, intermediates or final products.
Considerations are given for all aspects that can influence the final outcome of a cryopreservation process including the selection, development and validation of cryopreservation methods as well as storage, transport and handling processes.
This document is applicable to biologics that are cells and cellular therapeutic materials and tissue engineered materials that exist in the form of starting materials, intermediates and final products.
The document is applicable to cryopreservation and recusitation of cell materials, including organoids, provided to and from biobanks.
This document is not applicable to biologics that are drugs, cell-free scaffolds, acellular preparations, blood and blood products other than leukocytes, minimally manipulated tissues and whole organs, or preservation methods using hypothermic storage, freeze drying or vitrification.
This document is intended for all stages of cell therapeutic development including research and manufacturing, where the final product is intended for human application.