DBT - NIBEC

Overview

  • National Immunogenicity and Biologics Evaluation Center, was established jointly by Interactive Research School for Health Affairs IRSHA , Bharati Vidyapeeth University, Pune and the Department of Biotechnology, Government of India under BIRAC-National Biopharma Mission-Innovate in India (i3 ) program.
  • The facility was inaugurated virtually by Dr. Renu Swarup, Secretary, DBT, Government of India in an e-inauguration ceremony on 4th September 2020
  • Testing solutions for vaccine immunogenicity and antivirals:  Involves a variety of methods and assays to assess the effectiveness of vaccines in stimulating an immune response and the potency of antiviral drugs in inhibiting viral replication.
  • https://www.youtube.com/live/XWRB478yK98?si=tEqTPuZ8zKfXOxUD

revamp

History

  • Apr 2023- Third cycle of Accreditations- NABL ISO/IEC 17025 : 2017
  • May 2022- BSL-3 Certification by DBT India (RCGM)
  • Apr 2022-  Implementation of Integrated LIMS with automated data transfer LIMS
  • Jan 2022- Development of assay for emerging SARC-CoV-2 (Omicron)
  • Apr 2021 - Development of assay of emergent SARS-CoV-2 variants
  • Mar 2021 - Second cycle of ISO/IEC 17025:2017 accreditation
  • Feb 2021 - Grant approval under Mission COVID Suraksha
  • Sept 2020 - Start of Antiviral testing services
  • Sept 2020 - Inauguration of NIBEC facility
  • July 2020 - Start of immunogenicity testing services for DENV,CHIKV and SARC Cov-2
  • July 2020- Start of antiviral testing for SARC Cov-2
  • May 2020 - SARS-CoV-2 based immunogenicity assay development in newly built BSL-3 facility
  • Feb 2019 - Establishment of NIBEC facility
  • Feb 2019 - Grant Approval under i3 program (NBM, DBT India)

Quality

  • Quality Unit assures compliance to consistently meet and improve quality requirements by integrating quality into every aspect of our bioanalytical services.
  • At NIBEC, Quality Management System (QMS) designed to achieve compliance with the Good Clinical Laboratory Practices (GCLP) and ISO/IEC 17025 Standard as the backbone of our regulatory practices.
  • We aim for continual improvements by adopting technological advances such as, implementation of IRSHA’s Information Management System (IMS) and Document Management System (DMS) in line with regulatory requirements.

Quality Policy

  • IRSHA commits to provide professional practices in biological testing abiding by applicable technical standards and guidelines including the laboratory quality management standard, ISO/IEC 17025: 2017. We seek to establish a well-integrated system to address public health issues.
  • Policy (Click to view)
  • ISO/IEC 17025:2017 (Click to view)

Facility

National Immunogenicity and Biologics Evaluation Center, was established in the year 2019, jointly by Interactive Research School for Health Affairs IRSHA , Bharati Vidyapeeth University, Pune and the Department of Biotechnology, Government of India under BIRAC-National Biopharma Mission.

NIBEC facility has BSL-2 and BSL-3 laboratories supported by other laboratories dedicated for sample management, serology, immunology and molecular assays, data center with restricted access.

The purpose of BSL- 2 & BSL-3 laboratories is to mitigate the risk of exposure of infectious agents handled in these laboratories to laboratory personnel, environment and community

Visitors

Health minister of Oman and delegates from Philippines Government visited NIBEC facility

 

Technical Staff

  • Mr. Shamburaje Pisal
  • Ms. Urmi Majumdar
  • Ms. Swati Bargal
  • Ms. Amita Kasana
  • Ms. Prajakta Rane
  • Ms. Tejashree Shendage
  • Mr. Shubham Kadlag
  • Ms. Rajkanya Toge
  • Ms. Sawani Karandikar
  • Mr. Omkar Kalaje
  • Ms. Abhilasha Kadu

Supporting Staff

  • Mr. Rahul Kadu
  • Mr. Rahul Patil
  • Mr. Tushar Bhosale
  • Mrs. Prajakta Jaswante
  • Ms. Meghana Walke
  • Mrs. Kiran Shende
  • Mr. Amol Ohol
  • Mahesh Humbe Toge

Scientific Staff

  • Dr.A.C Mishra
  • Dr. V.A Arankalle
  • Dr. Shubham Shrivastava
  • Dr. Harshad Patil
  • Dr. Ruta Kulkarni
  • Dr. Rashmi Virkar
  • Dr. Deepali Mali

Achievements

  • Establishment of world class laboratory for evaluation of the immunogenicity of vaccines & antiviral properties of drugs/preparations
  • Certification of BSL3 laboratory by Department of Biotechnology, Ministry of Science and Technology, Government of India.
  • Accreditation of various assays pertaining to vaccine immunogenicity as per ISO/IEC 17025:2017 standards by NABL
  • More than 40000 tests performed over the period of 4 years by various methods for various companies

Received best (2nd) poster Presentation award at International conference on “Emerging and Re-emerging viral infections impacting Human, Animals, Plants, Fish and Environment” for the research work titled “Antibody response to covid-19 vaccines used in India: An observational cohort study among healthcare workers”. 

Best (2nd) poster Presentation award at International conference (2022) on “Emerging and Re-emerging viral infections impacting Human, Animals, Plants, Fish and Environment” for the research work titled “Antibody subclass response to SARS-Cov2 in severe and non-severe covid-19 patients”. 

Testing services

Immunogenicity Assays

1. Virus Neutralization Assays

  • Gold standard technique for assessment of vaccine immunogenicity testing
  • Cell based assay employing live virus
  • Virus Neutralization can be monitored either by reduction in CPE (Microneutralization) or plaque count  (PRNT) for SARS-CoV-2 and Chikungunya Viruses and immunostaining for Dengue viruses
SARS-CoV-2

Plaque Reduction Neutralization Test (PRNT)

  • Wild type (Wuhan) [8004/2020/IND/PUNE-MT416726]
  • Kappa
  • Delta
  • Omicron BA.1
  • Coming Soon – Omicron BA.2

Microneutralization Test

  • Wild type (Wuhan) [8004/2020/IND/PUNE-MT416726]
  • Delta
  • Coming soon – Omicron BA.2
Chikungunya

Plaque Reduction Neutralization Test (PRNT)

  • Year of isolation - 2016
  • ECSA genotype [1572/2016/IND/PUNE-MW321606]
Dengue

Plaque Reduction Neutralization Test (PRNT)

  • All four dengue serotypes, year of isolation - 2016
  • DENV-1 [S19/2016/IND/PUNE-]
  • DENV-2
  • DENV-3
  • DENV-4
  • Customized assays for vaccine strain
  • Coming soon – flow cytometry based neutralization assay

2. ELISA

  • Assessment of antibody response to vaccines
  • Availability of different ELISAs for antigen and antibody detection
  • High throughput performance using automated liquid handling system and LIMS interface with multimode plate reader
  • Customization of assays on request
SARS-CoV-2

Anti-Spike-RBD IgG Detection and Quantification

  • Wuhan
  • Kappa
  • Delta
  • Delta Plus
  • Omicron

Anti-Nucleocapsid IgG Detection and Quantification

  • Wuhan

Other ELISAs

  • Anti-SARS-CoV-2 IgM
  • Anti-SARS-CoV-2 IgA
  • Anti-SARS-CoV-2 IgG subtyping
Chikungunya

Anti-CHIKV detection and quantification

  • Anti-CHIKV IgG
  • Anti-CHIKV E2
Dengue

Plaque Reduction Neutralization Test (PRNT)

  • Dengue NS1
  • Dengue IgM
  • Dengue IgG

3. T Cell Response

Validated assays available for assessment of cellular immune response against SARS-CoV-2, Dengue and Chikungunya

ELI Spot
  • Human IFN-γ
  • Human IL-4
Cytokine Profiling
  • Th1/Th2/Th17 cytokines
  • Multiplex bead capture assay (CBA)
  • ELISA
Flow Cytometry-Based Assay (Assay Validation As Per H62 Guidelines By CLSI)
  • Antigen specific T cells (CD4/CD8)
  • T cell Memory profile (Central & Effector memory cells)
  • Cytotoxic T cell response
  • Th1 cytokine response

4. Mesoscale Discovery

Validated COVID-19 ACE2 neutralization assay. Multiplex immunoassays, offer quantification of neutralizing antibodies against 10 antigens in single run.

SARS-CoV-2 V-PLEX Panel 7 (VoC Panel)
  • SARS-CoV-2 Spike (Wuhan)
  • SARS-CoV-2 Spike (B.1.351)
  • SARS-CoV-2 Spike (P.1)
  • SARS-CoV-2 Spike (B.1.1.7)
  • SARS-CoV-2 RBD (Wuhan)
  • SARS-CoV-2 RBD (B.1.351)
  • SARS-CoV-2 RBD (P.1)
  • SARS-CoV-2 RBD (B.1.1.7)
SARS-CoV-2 V-PLEX Panel 15 (Delta Variant Panel)
  • SARS-CoV-2 Spike (Wuhan)
  • SARS-CoV-2 Spike (AY.1)
  • SARS-CoV-2 Spike (AY.2)
  • SARS-CoV-2 Spike (B.1.617.2+dY144)
  • SARS-CoV-2 Spike (B.1.620)
  • SARS-CoV-2 Spike (B.1.1.7+E484K)
  • SARS-CoV-2 Spike (B.1.351.1)
  • SARS-CoV-2 Spike (B.1.618)
SARS-CoV-2 V-PLEX Panel 25 (Omicron Variant Panel)
  • SARS-CoV-2 Spike (Wuhan)
  • SARS-CoV-2 Spike (B.1.1.7)
  • SARS-CoV-2 Spike (B.1.1.529; BA.1)
  • SARS-CoV-2 Spike (B.1.351)
  • SARS-CoV-2 Spike (B.1.617.2; AY.4)
  • SARS-CoV-2 Spike (B.1.640.2)
  • SARS-CoV-2 Spike (BA.1+L452R)
  • SARS-CoV-2 Spike (BA.1+R346K)
  • SARS-CoV-2 Spike (BA.2)
  • SARS-CoV-2 Spike (BA.3)

Viral Assays

Molecular Biology-Based Assays
  • SARS-CoV-2 detection and quantification
  • Dengue virus serotyping and quantification
Cell-Culture Based Assays
  • SARS-CoV-2 plaque assay
  • Dengue virus plaque assay
  • Dengue virus NS1 ELISA-based TCID50 test (NSET)
  • Chikungunya virus plaque assay

Antiviral Assays

Evaluation of the Antiviral Efficacy of surface disinfectants; drugs antimicrobial formulation treated textiles; papers; plastics; non-porous materials; against SARS-CoV2 virus and its variants is the mainstay of antiviral testing services at NIBEC.

Our customized and focused approach with a fast turnaround time allows us to provide a quality service.

Textiles and Paper ISO 18184 :

Determination of antiviral activity of textile products 

We test antiviral treated porous material referring to the International standard guideline ISO 18184which specifies the methodology for determination of the antiviral activity of the textile products against viruses.

Textiles : Face mask; Gloves; Surgical gown

Papers : Coated hard and soft papers; Tissue paper

Virus strain : SARS-CoV-2 and its variants

Plastics and Coatings ISO 21702 :

Measurement of antiviral activity on plastics and other non-porous surfaces 

We test efficacy of antiviral treated plastics and non-porous material referring to the International standard guideline ISO 21702.

Plastics Films : Glass

Stainless Steel : Paint coatings

Virus Strain : SARS-CoV-2 and its variants

Chemical Disinfectant : EN14476 : 2019

Measurement of antiviral activity on plastics and other non-porous surfaces 

We test the virucidal efficacy of chemical disinfectants, commercial formulations referring to European guideline.

Examples: Soaps, Sanitizer, Gels, Surface and textile disinfectants, spray hygenizers

Virus Strain : SARS-CoV-2 and its variants

DRUGS and NCEs :

We test antiviral efficacy of the drug formulations, herbal formulations, prosthetic drugs, new chemical entity in three different modes

 

  • Prophylactic
  • Therapeutic
  • Virucidal

We design and customize the assay protocol as per the client's requirement to evaluate the efficacy of the product.

Virus Strain : SARS-CoV-2 and its variants

Other Products

For any other products (throat/ oral sprays) for its antiviral evaluation, or for any other customization in the standard assays, we assist in planning of the right assay to evaluate the efficacy of your product

Virus Strain : SARS-CoV-2 and its variants

 

Mail Us @ : services.nibec @bharatividyapeeth.edu

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