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EMEA: Guideline on development, production, characterization and specifications for monoclonal antibodies and related products

30.01.2009

EMEA:
Guideline on development, production, characterization and specifications for monoclonal antibodies and related products. This guideline addresses quality issues for the marketing authorisation of monoclonal antibodies derived from a monoclonal cell line, and intended for therapeutic and prophylactic use (including ex vivo application), and in vivo diagnostic use.