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Eudralex Volume 3 NOTE FOR GUIDANCE ON QUALITY OF BIOTECHNOLOGICAL PRODUCTS: DERIVATION AND CHARACTERISATION OF CELL SUBSTRATES USED FOR PRODUCTION OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS

Origin/Publisher:

European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium), http://ec.europa.eu/enterprise/

Document Type:
Note for Guidance
Content:
The objective of this guideline is to provide broad guidance on appropriate standards for the derivation of human and animal cell lines and microbial cells to be used to prepare biotechnological/biological products defined in Section 1.3, Scope, and for the preparation and characterisation of cell banks to be used for production. The document, therefore, provides recommendations on the information in these areas that should be presented in marketing applications for these products.

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