Therapeutic Antibodies Laboratory




The Therapeutic Antibodies laboratory has been set up in March, 2012 to undertake Quality control testing of therapeutic monoclonal antibodies received from CDSCO, its zonal/ sub-zonal offices, state drug regulatory authority or directly from the manufacturers. The Therapeutic Monoclonal Antibodies (mAbs) are tested for their physiochemical parameters as well as for their in-vitro biological activity. To evaluate the biological activity of therapeutic biologics, the centralised facility of bioassay (CFB) has been set up in June 2018 to undertake quality control testing of therapeutic monoclonal antibodies as well as the inter laboratory biological samples. The laboratory is also actively involved in the preparation of Monographs to be incorporated in Indian Pharmacopeia in collaboration with Indian Pharmacopoeia Commission.