Development, production, characterisation and specifications for monoclonal antibodies and related products
| Current effective version |
|
| Reference number | EMA/CHMP/BWP/532517/2008 |
| Published | 04/08/2016 |
| Effective from | 01/09/2016 |
| Keywords | Monoclonal antibody, recombinant proteins, quality, characterisation, specification, hybridoma |
| Description | 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. |
Document history
Revision 1 Current version |
| Published: 04/08/2016 Effective date: 01/09/2016 |
First version
| In operation: 01/07/2009–31/08/2016 Published: 18/12/2008 Published: 05/04/2007 Published: 21/10/2004 | |
| Superseded document |
| Published: 02/11/2009
In operation: 01/01/1992–30/06/2009 |
| Superseded document |
 Adopted guideline
| In operation 01/07/1995-30/06/2009 |
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