Eudralex Volume 3 GUIDELINE ON PRODUCTION AND QUALITY OF MONOCLONAL ANTIBODIES AND RELATED SUBSTANCES

Title:
Eudralex Volume 3 GUIDELINE ON PRODUCTION AND QUALITY OF MONOCLONAL ANTIBODIES AND RELATED SUBSTANCES

https://www.gmp-compliance.org/files/guidemgr/Quality MAB.pdf

Origin/Publisher:

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

Document Type:
CHMP Guideline
Content:
In this guideline, specific requirements for monoclonal antibodies for therapeutic and prophylactic use(including ex vivo application) and in vivo diagnostic use are described. In addition, requirements for monoclonal antibodies used as reagents, especially in the purification of other pharmaceutical products are described.

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