Introduction

Recombinant Products Laboratory is a notified Central Drugs Laboratory (CDL) by Government of India for Quality Control Evaluation (QCE) of Recombinant Products i.e. Insulin, Insulin Analogues, Growth Factors, Cytokines and Peptides. Every batch of recombinant product received for QCE is tested for its quality attributes as per current version of Indian Pharmacopoeia for pharmacopoeial products and as per manufacturer's protocol for Non Pharmacopoeial products. The emerging biosimilars in market makes it imperative to carry out QC testing of these biologicals to ensure availability of safe, efficacious and potent biomolecule to end-users.

Notification

Laboratory has been notified as CDL vide Gazette No. 908E, dated, 22nd December, 2014 and Government analyst notified from lab vide Gazette notification No 3840 dated 26th November 2019.

Accreditation

The Laboratory has a Quality Management System in place and is NABL accredited for testing of Recombinant Products in accordance with ISO/IEC 17025:2017 standard as per the scope defined for the discipline of Biological testing and Chemical testing Lab has also been accredited for “Occupational Health and safety Assessment Series (OHSAS) 18001”

Reference Standard

Laboratory has developed two National Reference Standards namely Indian Pharmacopoeia Reference Standard (IPRS) for Human Insulin (2010) and IPRS for Insulin Lispro (2014). These are being purchased by various indigenous manufacturer to get reliable data for quality control purpose. It also helps many new manufacturers to set up the facility for preparation of the drug product. The link to IPRS is also available on IPC website so as to facilitate its purchase.

Monographs

A total of 21 monographs have been contributed from Recombinant Products Laboratory in the Indian Pharmacopoeia. Lab has been carrying out monograph verification for new products for various in vitro and physiochemical test parameters as and when required so as to harmonize the test protocol. Lab also gives expert opinion for the purpose of incorporation of amendment(s) proposed by any stakeholder in the existing monograph.

Training

Recombinant Products Laboratory (RPL) carried out National Workshop on Laboratory Quality Management Systems in Biotherapeutics with participants from industry, academia, regulatory and manufacturing at National Institute of Biologicals, NOIDA. RPL also does the handholding of the manufacturers to resolve the issues faced during QC testing at their premises by extending the technical expertise from the lab.

Collaborative studies & Proficiency testing

Laboratory has collaborated with various National and International agencies like WHO, NIBSC, EDQM for Interlaboratory Collaborative studies, as a part of proficiency testing programme which is an ongoing process and a requirement of ISO 17025:2017

Interlaboratory testing of samples

Laboratory is extensively involved in Interlaboratory testing of samples from other laboratories of NIB for test parameters such as Bacterial Endotoxin Test by Kinetic Chromogenic assay, Osmolality, Light obscuration by Particle measuring system for particulate contamination, HPLC based test. These tests are carried out for various batches of Vaccines, Monoclonal Antibodies, Recombinant Enzymes , Blood products etc.

Publications

The regulatory work carried out by lab has been reflected by publications in various National and International journals of repute. Lab staff has also participated in various workshop and conferences to spread the awareness about the importance of QC testing of biotherapeutics.

Joint Inspections

Scientists of Recombinant Product Laboratory have been participating as experts in joint cGMP inspection of Biotherapeutic Manufacturing Units in India with CDSCO and state FDA for recombinant bio therapeutics.