National Immunogenicity & Biologics Evaluation Center (A DBT-BIRAC initiative under National Biopharma Mission)

Establishment of NIBEC, a National Center, at Bharati Vidyapeeth (Deemed to be University)

Bharati Vidyapeeth (deemed to be University) is committed to social transformation through dynamic education. Translational research holds key to much needed transformations in Society. The University participated in a flagship Mission Program “Innovate in India (i3)” of Department of Biotechnology (DBT), Government of India through one of its constituent Unit-Interactive Research School for Health Affairs (IRSHA). Under this translational program, Rs 16.0 Cr was provided for development of “National Immunogenicity and Biologics Evaluation center (NIBEC)” for evaluation of viral vaccines in clinical trials. This facility is intended to provide fillip to a critical gap in development of vaccines in India. Earlier, we depended upon facilities abroad which are expensive and took a long time to give results causing delay in getting regulatory approvals for vaccines.

NIBEC, having a dedicated area of about 10,000 sq. ft., was established in a record time of just a year. It has state of the art BSL-3+, 4 BSL-2 and 10 BSL 1 laboratories. Handling of experiments involving live viruses of BSL-3 categories are performed in BSL-3 Lab and work with live viruses of BSL-2 are done in BSL-2 laboratories. All other work is done in BSL-1 areas. BSL-3 laboratory has defined perimeter. Entry and exit for personals are through change-shower-change room. Shower is optional and can be used both entry and exit or only for exit depending upon the risk assessment and protocol. Perimeter also has a modern autoclave for transfer of contaminated materials, pass box for transfer of reagents and experimental materials, and a material transfer hatch for transfer of equipment, furniture etc. The facility has been provided with an industrial grade H2O2 system for decontamination. Undoubtedly, this is one of the best BSL-3 facilities in the country.

The facility is a GCLP and Biosafety compliant. These compliances require strict adherence to the good clinical laboratory practices. We have a dedicated sample handling area, Independent laboratories for PRNT, micro neutralization, Plaque assay, molecular assays, serological assays, and flow cytometry based assays. The facility has high end equipment.

Following the sudden emergence of Covid-19 pandemic in India, we isolated several strains of Corona-2 viruses, characterized them, developed critical tests like PRNT, Micro neutralization, IgG & IgM Elisa. We already supported several industries by evaluation of their clinical samples of vaccine candidates and also for development of hyper immune serum in equines.

We work with major vaccine manufacturers like Serum Institute of India, Pune, Bharat Biotech International Ltd, Hyderabad, Indian Immunologicals, Hyderabad, Cedilla Biopharma, Ahmedabad, Gennova Ltd, Pune, Engene Ltd, Pune. For antiviral evaluations, we work with IITs, Pharmacy colleges, research institutions and major healthcare companies like Godrej, ITC, Wipro etc. We have also entered into an agreement with International Vaccine Institute, South Korea to work for a multi country clinical trial of Chikungunya vaccine.

In true sense, this project is a positive step towards meeting the clarion call given by our Hon prime Minister “Atmanirbhar Bharat”.

About

Under Innovate in India (i3) program of Government of India, DBT-BIRAC under National Biopharma Mission has awarded Interactive Research School for Health Affairs (IRSHA), a constituent unit of Bharati Vidyapeeth University a project for the establishment of this center with a grant of Rs 16.0 Crore. The center is envisaged to accelerate inclusive innovation in development of human vaccines in India. This is the first center of its kind in the country. It will have close linkage with Department of Biotechnology and the major industries engaged in development of human vaccines in India. Bharati Vidyapeeth is in the process of establishing a high containment, GCLP compliant facility for implementation of this project.

The center has state of art facility aimed at providing immunogenicity evaluations of the vaccines in developmental pipe line particularly during clinical trial and to support antiviral drug evaluations to developers/manufacturers. Learn more....

Mission

Developing a world class facility for evaluation of the immunogenicity of vaccines & antiviral properties of drugs/preparations.