INDIA'S FIRST GMP-COMPLIANT BIOFOUNDRY FOR BIOPHARMACEUTICAL
The vision of our Biofoundry is to become India's first centralized hub for the efficient production, characterization, and storage of genetically modified strains, engineered microorganisms, and other biological entities. Our Bio foundry focuses on the creation, maintenance, and standardized management of a collection of cell banks for use in Biotherapeutics, and Biomanufacturing applications including vaccines, and other bio-based products.
This Biofoundry will ensure the availability of GMP-quality, well-characterized cell banks, which will be available for a wide range of Biopharmaceutical research and commercial purposes. The ultimate goal of this Biofoundry is to accelerate innovation and collaboration in Biopharmaceutical research domain while ensuring high quality, reproducibility, and regulatory compliance.
Our Goal
National Repository of GMP compliant Microbial Cell bank of Bio-Pharmaceutical relevance (NRGCBIO) established in 2021, is a nonprofit, national microbial resource center, standard organization, developer & supplier of authenticated cells banks of different microorganisms for Biotherapeutic/Biopharma applications. This will be first of its kind facility in public sector in India. Overall establishment of such facility in Indian institute will largely be in alignment with Make in India and Skill India mandate of Government.
- Establishment of GMP-Compliant Facility for Microbial Cell Bank Repository at CSIR IMTECH
- Acquisition of cell lines of Microbial and Yeast and improved expression vectors from various national and international sources and individual innovators.
- Production of Master Cell Bank (MCB) and Working Cell Bank (WCB) of acquired cell banks following GMP guidelines.
- Characterization of GMP cell banks as per FDA- ICH regulatory guidelines.
- Supply of cGMP cell banks to R&D institutions and industries (including small entrepreneurs, startups and SMEs)
- Bridging the gap of availability and access of well-characterized microbial cell lines used for biopharmaceutical development in R&D institutions and Industries across India.
- Human resource development by organization of hand-on trainings and workshops on GMP cell banking and its characterization.
Vision and Mission
- Establishment of India's first GMP–compliant cell bank repository to support Academic research institutions and Biopharmaceutical Industries Availability of well characterized and affordable cell banks is a major the area in Biopharmaceutical development, such as recombinant therapeutic protein, Biosimilars, vaccines and enzymes etc.
- Affordable, and well characterized cell banks for R&D, QC and production of Biopharmaceuticals include but not limited to, recombinant therapeutic proteins, therapeutic enzymes, and recombinant protein subunit vaccines. Affordability and availability of well characterized cell banks from authentic source are major challenges in Biopharmaceutical development. The availability of a GMP grade cell bank will be an enormous help for Biopharmaceutical development in Nation. This facility will aid to Government of India's 'Make In India' mandate.
- Training of scientists, industry personals and students on GMP guidelines and SOP's related to cell line production and banking. In addition training will be imparted in the area of GMP regulations as per national and international guidelines. The training in the Good Manufacturing Practices (GMP) and regulatory guidelines for a biotherapeutic drugs/ biologics is major thrust area that will be complemented by this facility. The training programme will be well aligned with Indian government's 'Skill India' mandate.
Future Plan
- Ease in the availability of well-characterized cell banks as per international regulatory guidelines such as FDA-ICHQ5A, Q5B and Q5D to ensure the safety of cell lines for Biotherapeutics development.
- Provide ready to use GMP compliant cell banks for Biopharmaceutical R&D in India. Currently getting a cell lines in India suffers through various shortcomings like very high cost, licensing and royalty's charges, uncertainty in identity and purity shipping costs, delays in delivery and customs duty payment. Having such facility in India will fill this gap.
- Training of students, technical staffs and scientist with GMP regulations will benefit the existing knowledge gap in this space.
- This will be first of its kind facility in public sector in India. Overall establishment of such facility in Indian institute will largely be in alignment with Make in India and Skill India mandate of Government.
Our Services
CELL BANKING TO BIOMANUFACTURING
An initiative for Atmanirbhar Biopharma
Accelerating Discovery Research to Early Development of microbial technology derived Biopharmaceuticals with the support of Biotechnology Industry Research Assistance Council (BIRAC), National Biopharma Mission (NBM), Government of India.
Bridging the Gaps in National Biopharmaceutical Domain
The NRGCBIO facility strives to fulfill its objectives by giving utmost importance to the needs of the customers by providing quality products and services as per cGMP principles.
Small Scale Fermenter- Downstream Facility
- Cell Bank Cryopreservation Facility
- Cell Bank Characterization lab
- National Repositories
- International Repositories
- National R&D Institutions
- In-house & collaborative Development
