BSI PD ISO/TS 20399-1:2018

Withdrawn Revision
Biotechnology. Ancillary materials present during the production of cellular therapeutic products -- General requirements

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BSI PD ISO/TS 20399-1:2018

Biotechnology. Ancillary materials present during the production of cellular therapeutic products -- General requirements

PUBLISH DATE 2019
PAGES 20
BSI PD ISO/TS 20399-1:2018

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.

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