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.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviated terms
5 Considerations
5.1 General considerations
5.2 Animal-derived components of AM
5.2.1 General
5.2.2 Levels of ADCF
5.2.3 Key considerations in the use of animal-derived components
5.2.4 Viral inactivation
5.3 Mutual responsibilities for AMs
5.4 Example workflow
6 Ancillary material requirements
6.1 Quality management system
6.2 Information on ancillary material products and materials used to produce ancillary materials
Annex A (informative) Example of workflow from AM supplier to AM user
Annex B (informative) Information on AM products and materials used to produce AM
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviated terms
5 Considerations
5.1 General considerations
5.2 Animal-derived components of AM
5.2.1 General
5.2.2 Levels of ADCF
5.2.3 Key considerations in the use of animal-derived components
5.2.4 Viral inactivation
5.3 Mutual responsibilities for AMs
5.4 Example workflow
6 Ancillary material requirements
6.1 Quality management system
6.2 Information on ancillary material products and materials used to produce ancillary materials
Annex A (informative) Example of workflow from AM supplier to AM user
Annex B (informative) Information on AM products and materials used to produce AM
Bibliography