Recombinant Product, Enzymes & Hormones & Therapeutic Antibodies Laboratory




Recombinant Product Laboratory (RPL ), a CDL notified and NABL accredited Lab contributes to the Regulatory functions of recombinant bio therapeutic products under the class of: Insulin, Insulin Analogs, Growth Factors , Cytokines and Peptides. These products are intended for therapeutic indications for the treatment of diabetes (Type 1 and Type 2), viral hepatitis, chronic kidney disease, cancer, osteoporosis.The QC testing of the pharmacopoeial products are carried out as per current version of Indian Pharmacopoeia and as per manufacturer's protocol for Non Pharmacopoeial products.

Enzymes and Hormones Laboratory is primarly involved in Quality control (QC) testing of various therapeutic Enzymes and Hormones. Additionally, laboratory functions include monograph preparation for incorporation in Indian Pharmacopoeia, monograph test method verification, test method standardization of new Biologicals and Bio therapeutics, participation in proficiency testing, Inter-Laboratory Collaborative Studies and preparation of working reference standards. Enzymes and Hormones batches received in laboratory are evaluated as per their respective monographs in latest editions of Pharmacopoeias like Indian Pharmacopoeia, United States Pharmacopoeia, European Pharmacopoeia, British pharmacopoeia etc.

Enzymes and Hormones Laboratory got notified as CDL under Gazette Notification No.: G.S.R. 250 (E) - Part-II - Section 3 - Sub-Section (i) dated 15th March, 2017

1. Streptokinase (Natural and Recombinant)
2. Human Chorionic Gonadotropin (hCG)
3. Human Menopausal Gonadotropin (hMG)

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.