DBT - NIBEC | Irsha | Bharati Vidyapeeth

Overview

Total clients – 75 +
Total projects - 90+
Clinical Trials : 15+
Preclinical Studies : 15+
Antiviral Studies : 60+
Third cycle of Accreditations- NABL ISO/IEC 17025 : 2017
SARS-CoV2 Variants - Wild, Kappa, Delta, Omicron-XBB, BA.1,BA.5

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

History

April 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)

History

April 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)

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

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)

Organogram

Technical Managers

Technical Staff

Name Of Staff

Mr. Shamburaje Pisal Quality Control Officer
Ms. Urmi Majumdar Deputy Quality Control Officer
Ms. Swati Bargal Quality Assurance Executive
Ms. Amita Kasana Technical Managers
Ms. Prajakta Rane Technical Managers
Ms. Tejashree Shendage Technical Staff
Mr. Shubham Kadlag Technical Staff
Ms. Rajkanya Toge Technical Staff
Ms. Sawani Karandikar Technical Staff
Mr. Omkar Kalaje Technical Staff
Ms. Abhilasha Kadu Technical Staff

Scientific Staff

Name Of Staff

Dr.A.C Mishra Director
Dr. V.A Arrankle Senior-scientist
Dr. Shubham Shrivastava Quality Manager
Dr. Rashmi Virkar Training Incharge
Dr. Harshad Patil Facility In-Charge
Dr. Ruta Kulkarni Laboratory Manager
Dr. Deepali Mali Deputy Laboratory Manager

Supporting Staff

Name Of Staff

Mr. Rahul Kadu Maintenance Engineer
Mr. Rahul Patil IT Officer and Archivist
Mr. Tushar Bhosale IT and EHS-officer
Mrs. Prajakta Jaswante Purchase Officer
Ms. Meghana Walke Support staff
Mrs. Kiran Shende Support staff
Mr. Mr. Amol Ohol Support staff
Mr. Mahesh Humbe Toge Support staff

Antiviral Testing

With the newly established BSL3 facility, we took up the challenge to develop SARS-CoV-2 related assays to cater the demands of vaccine manufacturers, pharma and healthcare industries
During national lockdown in March 2020, NIBEC staff was actively involved in collection of clinical samples from COVID19 wards across Pune. We successfully isolated SARS-CoV-2 virus and developed assays for vaccine immunogenicity and antivirals.
We currently have assays available for SARS-CoV-2 variants [Wild type (Clade G); Delta; Kappa; Omicron]

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