Introduction

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 centralized 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 has the infrastructure and expertise for testing different types of therapeutic monoclonal antibodies, antibody fragments or fusion proteins.

Notification

The laboratory has initiated for CDL notification and same is under consideration by CDSCO

Accreditation

The Laboratory has a Quality Management System in place and is NABL accredited for testing of Blood grouping reagents and gel cards in accordance with ISO/IEC 17025:2017 standard for Chemical Biological tests, vide Certificate No. TC-7725.

Batch Release Testing

Laboratory has International reference standards obtained from National Institute of Biological Standards and Control (NIBSC), UK, European Directorate for the Quality of Medicines & HealthCare (EDQM), National Institute of Standards and Technology (NIST) and Pharmacopoeial system suitability standards for various quality control characterization of therapeutic monoclonal antibodies/antibody fragments/fusion proteins. For batch release, tests are carried out as per the Indian Pharmacopoeia /other any other pharmacopeia (if India pharmacopoeial monograph is not available) or as per the Manufacturer’s in-house specifications in case of non-pharmacopoeial products.

Monographs

The laboratory is actively involved in the preparation of Monographs to be incorporated in Indian Pharmacopeia in collaboration with Indian Pharmacopoeia Commission.

Training

The Laboratory has been imparting training in cutting edge technologies to various PG/UG students under National Skill Development and Hands -On -training on Quality Control of Biologicals organized by National Institute of Biologicals, NOIDA.