BSI PD ISO/TS 20399-2:2018
$102.76
Biotechnology. Ancillary materials present during the production of cellular therapeutic products – Best practice guidance for ancillary material suppliers
| Published By | Publication Date | Number of Pages |
| BSI | 2018 | 20 |
This document provides guidance for ancillary material (AM) suppliers to maintain a high level of lot-to-lot consistency in the aspects of identity, purity, stability, biosafety, performance, as well as the accompanying documentation.
This document is applicable to cellular therapeutic products, including gene therapy products whereby cells form part of the final product. It does not apply to products without cells.
The AMs described in this document include those of biological origin [e.g. sera, media (including media additives), growth factors, and monoclonal antibodies] and chemical origin. This document does not address dimethyl sulfoxide (DMSO) for cryopreservation, beads, scaffolds, feeder cells, apparatus and instruments, or additives used post bioprocessing.
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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | National foreword |
| 6 | Foreword |
| 7 | Introduction |
| 9 | 1 Scope 2 Normative references 3 Terms and definitions 4 Abbreviated terms |
| 10 | 5 General considerations |
| 11 | 6 AM characteristics and quality attributes 6.1 AM components, identity and purity 6.1.1 General 6.1.2 Identity and quantity of component(s) 6.1.3 Purity/impurity 6.1.4 Lot-to-lot consistency for AMs containing proprietary components |
| 12 | 6.2 AM storage and stability 6.2.1 General 6.2.2 Storage conditions 6.2.3 Stability and expiration dating |
| 13 | 7 AM manufacturing and biosafety 7.1 Quality management system 7.2 Manufacturing process 7.3 Container and closure systems |
| 14 | 7.4 Animal- and human-derived materials 7.5 Safety to cells and humans 8 AM performance 8.1 General |
| 15 | 8.2 Performance assay 8.2.1 General 8.2.2 AMs that support cell survival and function 8.2.3 AMs that are intended to promote specific cell functions 8.3 Cells used for performance assays |
| 16 | 8.4 Performance assay results 9 AM documentation 9.1 General 9.2 Certificate of analysis (CoA) |
| 17 | 9.3 Additional certificates 9.3.1 Certificate of origin (CoO) 9.3.2 Certificate of compliance (CoC) 9.3.3 Certificate of irradiation (CoI) 9.4 Other items |
| 18 | Bibliography |
