ISO/TS 20399-1:2018

Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 1: General requirements

This document 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.

NOTE International, regional or national regulations or requirements can also apply to specific topics covered in this document.

Edition	2018
Standard Part No	1
Published Date	2018
Published By	ISO/TS
Page Count	10