Development, production, characterisation and specifications for monoclonal antibodies and related products

Current effective version

PDF icon Adopted guideline

Reference numberEMA/CHMP/BWP/532517/2008
Effective from01/09/2016
KeywordsMonoclonal antibody, recombinant proteins, quality, characterisation, specification, hybridoma
DescriptionThis revision is a technical update to reflect current best practice with regard to implementation of 3Rs approaches and it is not intended as a full revision of this guideline (only sections 1, 5.3 and 6.3 are affected). In addition, minor changes have been introduced to reflect the new Agency templates, for example addition of an Executive Summary. All these changes are considered to be minor and uncontroversial and consequently a consultation phase was considered to be unnecessary.

Document history

Revision 1

Current version

PDF icon Adopted guideline



Published: 04/08/2016

Effective date: 01/09/2016

First version


PDF icon Adopted guideline


PDF icon Overview of comments


PDF icon Draft guideline


PDF icon Concept paper

In operation: 01/07/2009–31/08/2016


Published: 18/12/2008


Published: 05/04/2007


Published: 21/10/2004

Superseded document

PDF icon Concept paper


PDF icon Adopted guideline

Published: 02/11/2009


In operation: 01/01/1992–30/06/2009

Superseded document PDF icon Adopted guideline In operation 01/07/1995-30/06/2009

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