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

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Current effective version

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

Adopted guideline


Published: 04/08/2016

Effective date: 01/09/2016 

First version


Adopted guideline

Overview of comments

Draft guideline

Concept paper

In operation: 01/07/2009–31/08/2016

Published: 18/12/2008

Published: 05/04/2007

Published: 21/10/2004

Superseded document

Concept paper


Adopted guideline

Published: 02/11/2009


In operation: 01/01/1992–30/06/2009

Superseded documentAdopted guidelineIn operation 01/07/1995-30/06/2009

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