Title: Biotechnology — ancillary materials present during the production of cellular therapeutic products : general requirements

Scope: Specifies definitions and general requirements for ancillary materials (AMs) used in cell processing of cellular therapeutic products. This document is applicable to cellular therapeutic products, including those gene therapy products whereby cells form part of the final product. It does not apply to products without cells. This document does not cover the selection, assessment or control of starting materials and excipients

Standard Status: Current

Equivalent Standard: ISO/TS 20399-1:2018

Group: Gr. E