Context

The National Immunogenicity and Biologics Evaluation Centre (NIBEC) for assessing clinical immunogenicity of viral vaccines, especially the ones in the pipeline for Covid-19, has been inaugurated.

About

• Established jointly by Bharati Vidyapeeth University through its constituent unit Interactive Research School for Health Affairs (IRSHA) and BIRAC-DBT, Government of India through National Biopharma Mission, the facility was inaugurated virtually in an e-inauguration ceremony.
• NIBEC, established in about 10,000 sq ft, has one BSL-3+, 4 BSL-2 and 10 BSL-1 laboratories.
• Evaluation tests: Key immunogenicity evaluation tests like Plaque Reduction Neutralization Test (PRNT), Microneutralisation assay, IgM and IgG ELISA, developed, standardised and validated for dengue, chikungunya and SARS-CoV-2 viruses.

What is National Biopharma Mission?

• The Mission Programme is a Pan-India Programme with the main aim of making India a hub for design and development of novel, affordable and effective biopharmaceutical products and solutions.
• It is an Industry-Academia Collaborative Mission of Department of Biotechnology (DBT) for Accelerating Early Development for Biopharmaceuticals.
• The mission is implemented by Biotechnology Research Assistance Council (BIRAC).

Biotechnology Industry Research Assistance Council (BIRAC) Biotechnology Industry Research Assistance Council (BIRAC) is a not-for-profit Section 8, Schedule B, Public Sector Enterprise. It is set up by Department of Biotechnology (DBT) as an Interface Agency to strengthen and empower the emerging Biotech enterprise to undertake strategic research and innovation, addressing nationally relevant product development needs. BIRAC is a industry-academia interface, its key strategies include: Foster innovation and entrepreneurship Promote affordable innovation in key social sectors Empowerment of start-ups & small and medium enterprises Contribute through partners for capability enhancement and diffusion of innovation Enable commercialization of discovery Ensure global competitiveness of Indian enterprises

 

Significance of the development

• Vaccine development requires extensive evaluation in humans to establish safety, immunogenicity and clinical efficacy. Centralised viral and bacterial clinical immunogenicity labs meeting the stringent standards is a critical need for the vaccine industry.
• Domestic capabilities maintaining international standards in this space will accelerate and fast-track the development of indigenous vaccines in India.