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