Home  |   Sitemap  |   Contact

Interactive Research School For Health Affairs (IRSHA), Pune

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 tosupport antiviral drug evaluations to developers/manufacturers.

Introduction

India has strong institutions with robust R&D pipeline of vaccine development. In addition, Indian manufacturers acquire many technologies from various international sources. After technology acquisition, vaccine development requires extensive clinical evaluation to prove its clinical efficacy. This requires rigid regulatory compliance which needs enormous safety and immunogenicity data. We have many GCLP laboratories providing quality pre-clinical safety data. However, GCLP compliant immunogenicity testing laboratories are not available in India. More often, blood or plasma samples have to be shipped abroad. Testing abroad is not only expensive but to get regulatory approvals for shipping of samples is cumbersome and time consuming. Therefore, India needs a few State of the Art centers to provide comprehensive immunogenicity testing services to our vaccine manufacturers.

Viral vaccine facilities require both GCLP as well as Biosafety compliant laboratories. Therefore, making such a laboratory, is a real challenge. This project has to be innovative to match with the twin compliances. If successful, we will be able to provide a unique facility that will meet the long pending need of vaccine manufacturers in our country.

Present challenges and Goals:

Presently, majority of tests required for vaccine evaluation are available with research facilities or institutions in the country. However, these research institution facilities cannot meet the rigid regulatory requirement of data keeping, traceability, equipment maintenance and calibrations due to various in-built constraints. We propose to get technologies from such laboratories and put them in practice in an industrial type of environment. This requires dedicated facility and innovative thinking, large resources.

Objectives:

  1. Establishment of GCLP laboratories for immunogenicity testing of vaccines. This would include setting up of dedicated Biosafety 2 and 3 laboratories which should be compliant to both Biosafety and GCLP requirements.
  2. Acquisition, standardisation, validation and finally accreditation of the tests required for immunogenicity testing of vaccines.
  3. Creation of self-sustainable business model, capable of absorbing new technologies and maintain pace with newer developments in the field.

Approach:

A. Laboratory infrastructure

The university management has allocated about 8,000 sqft. space on 3rd floor of the institute’s building for this purpose. The facility will have the following:

  • State of Art BSL-2 and BSL-3 laboratories
  • Appropriate certified and high rated equipment
  • Adequate power back up by providing DG set, invertors and UPS
  • Data loggers for monitoring of temperature of freezers, refrigerators, cold cabinet etc.
  • Building management system [BMS]
  • Laboratory Information Management system [LIMS]

B. Human resources:

Qualified scientists shall be involved for adsorption of technology, preparation of Standard Operating Protocols, training of staff etc. Dedicated trained staff will perform testing. Results will be reported by the supervisor after due verifications. We will appoint a laboratory manager, Quality assurance manager, technical officer [engineering] and data entry operators.

C. Rendering of already standardised and accreditated tests:

We have already standardised and received accreditation for Dengue PRNT, Dengue IgM capture ELISA and Dengue NS1 antigen ELISA. These tests will be migrated to the new facility after completion of re-accreditation formalities due to change of locations and infrastructure. Thereafter, these tests will be made available to customers.

D. Standardization of tests for accreditation

At NIBEC, we aim to render laboratory services for comprehensive evaluation of clinical immunogenicity of viral vaccines, Dengue – [DENV], Chikungunya [CHIKV,] and Respiratory Syncytial Virus - RSV. We propose to establish different assays for the investigation of virus-specific humoral and cell-mediated immune responses as well as quantitation of viruses. All the tests will be brought under the scope of NABL accreditation as per ISO / IEC 17025: 2017 standards.

E. Assessment and adsorption of new technologies for vaccine evaluation

Since vaccine research and evaluation is a dynamic field, NIBEC will remain committed to adoption of newer and best available technology for immunogenicity testing. This will involve regular liaisoning with national and global KoLs/WHO reference laboratories, research institutes, translation research consortia etc. These assays will be validated and brought under scope of NABL accreditation. NCIT will continue to work towards expansion of the testing service portfolio by including additional assays as per the demand by manufacturers and regulatory authorities.










NIBEC e-Inaugration Ceremony
© 2021 - National Immunogenicity & Biologics Evaluation Center, Bharati Vidyapeeth (Deemed to be University),
Pune-Satara Road, Pune – 411043, Maharashtra, India
Tel No. 020-24366920 | Email - This email address is being protected from spambots. You need JavaScript enabled to view it., This email address is being protected from spambots. You need JavaScript enabled to view it.
© 2021 - Bharati Vidyapeeth, Pune. All rights reserved. Developed and maintained by Technology Department, Bharati Vidyapeeth.