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European Medicines Agency

European Medicines Agency March 1998. CPMP/ICH/294/95. ICH Topic Q 5 D. Quality of Biotechnological Products: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products Step 5. NOTE FOR GUIDANCE ON. QUALITY OF BIOTECHNOLOGICAL PRODUCTS: DERIVATION AND. CHARACTERISATION OF CELL SUBSTRATES USED FOR PRODUCTION OF. BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS. (CPMP/ICH/294/95). TRANSMISSION TO CPMP January 1997. TRANSMISSION TO INTERESTED PARTIES January 1997. COMMENTS REQUESTED BEFORE July 1997. FINAL APPROVAL BY CPMP September 1997. DATE FOR COMING INTO OPERATION March 1998. 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK. Tel. (44-20) 74 18 85 75 Fax (44-20) 75 23 70 40. E-mail: EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged QUALITY OF BIOTECHNOLOGICAL PRODUCTS: DERIVATION AND. CHARACTERISATION OF CELL SUBSTRATES USED FOR PRODUCTION OF.

This document complements other guidelines to provide a comprehensive approach to quality issues arising from biological aspects of processing products from metazoan and microbial cell culture. 1.3 Scope This guideline covers cell substrates having a cell banking system. In this document, “cell

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