Development, production, characterisation and specifications for monoclonal antibodies and related products - Scientific guideline

This 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.

Keywords: Monoclonal antibody, recombinant proteins, quality, characterisation, specification, hybridoma

Current effective version - Currently under revision see concept paper below

Guideline on development, production, characterisation and specification for monoclonal antibodies and related products - Revision 1

AdoptedReference Number: EMA/CHMP/BWP/532517/2008Legal effective date: 01/09/2016

Revision 2

Concept paper on the revision of the guideline on 'Guideline on Radiopharmaceuticals based on monoclonal antibodies'

Draft: consultation closedConsultation dates: 21/07/2023 to 31/10/2023Reference Number: EMA/CHMP/BWP/245588/2023

Revision 1

Guideline on development, production, characterisation and specifications for monoclonal antibodies and related products

AdoptedReference Number: EMEA/CHMP/BWP/157653/2007Legal effective date: 01/07/2009

First version

Guideline on development, production, characterisation and specifications for monoclonal antibodies and related products

AdoptedReference Number: EMEA/CHMP/BWP/157653/2007Legal effective date: 01/07/2009

Overview of comments received on the guideline ''development, production, characterisation and specifications for monoclonal antibodies and related products''

Reference Number: EMEA/CHMP/BWP/651330/2008

Draft guideline on production and quality control of monoclonal antibodies and related substances

Draft: consultation closedReference Number: EMEA/CHMP/BWP/157653/2007

Concept paper on the need to revise the guideline on production and Quality control of monoclonal antibodies (3AB4A, Revision December 1994)

Reference Number: CHMP/BWP/64/04

Superseded documents

Concept paper on the revision of the guideline on radiopharmaceuticals based on monoclonal antibodies

Draft: consultation closedConsultation dates: 24/09/2009 to 31/01/2010Reference Number: EMEA/CHMP/CVMP/362268/2009

Guideline on radiopharmaceuticals based on monoclonal antibodies

AdoptedReference Number: 3AQ21ALegal effective date: 01/01/1992

Production and quality control of monoclonal antibodies

AdoptedReference Number: III/5271/94Legal effective date: 01/07/1995