IMTECH to set up CGMP facility with BIRAC Grant

01 - November - 2019

CSIR-Institute of Microbial Technology (IMTECH) has received approval for grant from National Biopharma Mission under Biotechnology Industry Research Assistance Council (NBM-BIRAC) to establish a new CGMP facility, which will be a National Repository of GMP Microbial Cell Bank of bio-pharmaceutical relevance.

Current Good Manufacturing Practices (CGMP) requires organizations to use technologies and systems that are up-to-date in order to comply with the regulations. It provides for the systems that assure proper design, monitoring and control of manufacturing processes along with facilities hence ensuring the identity, strength, quality and purity of drug products being manufactured.

 The proposed GMP Microbial Cell Bank at IMTECH will be used for research and development of biopharmaceuticals including biotherapeutics and vaccines. The grant anticipated, which is to the tune of fifteen crores, has been awarded by BIRAC under 'Innovate in India (I3) - Empowering Biotech Entrepreneurs & Accelerating Inclusive Innovation' scheme.

 The project will be headed by Dr. Ravi P.N. Mishra, Principal Scientist, CSIR-IMTECH and his team of other scientists who shall be responsible for establishing a state of the art GMP Microbial Cell Bank by a National Research Laboratory in India. Its mandate is to strengthen Industry-Academia collaboration as mandated by Government of India for accelerating discovery research to early development of biopharmaceuticals. The GMP facility will tentatively be functional for use to various stakeholders including pharma industries in a span of nearly two years subject to approval of Drug Controller General of India (DCGI).

Currently getting quality cell banks in India is a major challenge as it involves high cost, licensing and royalty charges, uncertainty in identity and purity, shipping costs, delays in delivery and customs duty payment. Having such facility in India will fill this major and much needed gap in biopharmaceutical space and is expected to catalyze India’s rapidly growing biopharmaceutical sector. The facility to be set up and completed in two years shall provide research organizations, startups, MSMEs and entrepreneurs with CGMP compliant microbial cell banks used for development of biopharmaceuticals at an affordable cost.

Dr. Manoj Raje, Acting-Director, CSIR-IMTECH congratulated the scientists and said, "This will be the first of its kind facility in India and will serve to the national mandate for development of affordable biological drugs like Biotherapeutics and Vaccines against various communicable and  non-communicable diseases. The facility will cater to the entire nation with the high quality microbial cell banks and expression systems for development of various Biopharmaceuticals, used for treatment and prevention of cancer, autoimmune disorders, heart related diseases and microbial infections."

 

 


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