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

We very much appreciate this new guideline as it will help to clearify and thus simplify the requirements for ancillary materials.