With the participation of CellGenix a new International Technical Standard was released by the International Organization of Standardization (ISO) providing guidance for ancillary material (AM) suppliers to maintain a high level of lot-to-lot consitency in the aspects of indentity, purity, stability, biosafety, performance, as well as the accompanying documentation.
ISO TS 20399 | Ancillary materials present during the production of cellular therapeutic products
- Part 1: General requirements
- Part 2: Best practice guidance for ancillary material suppliers
- Part 3: Best practice guidance for ancillary material users
We very much appreciate this new guideline as it will help to clearify and thus simplify the requirements for ancillary materials.