Monoclonal antibodies for veterinary use: specific questions to be addressed by the Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT) - Scientific guideline

The guidance, in the form of a question-and-answer document, relates to particularities of monoclonal antibodies for veterinary use, such as quality control for potential contaminants, stability testing, reproductive safety studies and data to address potential for indirect adverse effects.

Keywords: veterinary, monoclonal antibody

Current effective version

Questions and answers on monoclonal antibodies for veterinary use

Adopted Reference Number: EMA/CVMP/ADVENT/307606/2017

Document history

Draft monoclonal antibodies for veterinary use: specific questions to be addressed by ADVENT

Draft: consultation closed Consultation dates: 04/03/2016 to 15/05/2016 Reference Number: EMA/CVMP/ADVENT/276476/2015 Summary:

Monoclonal antibodies (mAbs) are immunoglobulins (Ig) with a defined specificity derived from a single clone of cells. Their biological activities are characterised by a specific binding characteristic to an antigen and may be dependent on immune effector function such as antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity.