DBT - NIBEC | Irsha | Bharati Vidyapeeth

Overview

Established under i3 program of National Biopharma Mission DBT, Govt. Of India.
Inaugurated by DBT-Secretary Dr. Renu Swaroop, 4th September 2020
Testing Solution for Vaccine immunogenicity and antivirals

Quality Manager

Dr. Shubham Shrivastava

Ph.D (Biotechnology)

Key Responsibilities

Oversee the testing activities carried out in the laboratory
Ensure resource management for timely and proper conduct of analysis of clinical trial samples

Quality Manager

Ms. Swati Bargal

MPharm (specialization in QA)

Ensure compliance of Quality management system
Conducting Internal audits

Quality Control Officer

Dr. Archana Munje

Ph.D (Biotechnology)

Implementing Quality Control Programme
Trend analysis of Reference materials and Quality control Samples

Laboratory Manager

Dr. Rashmi Virkar

Ph.D (Biotechnology)

Key Responsibilities

Oversee the testing activities carried out in the laboratory
Ensure resource management for timely and proper conduct of analysis of clinical trial samples

Facility In-Charge

Dr. Harshad Patil

Ph.D (Vaccine)

Oversee NIBEC facility to meet the biosafety compliance of RCGM guidelines, Govt of India
Oversee maintenance and calibration of equipment.

Flash Points

Total clients – 50 +
Total projects - 90+
Clinical Trials : 15+
Preclinical Studies : 15+

Antiviral Studies : 60+
Second cycle of Accreditations- NABL ISO/IEC 17025 : 2017
SARS-CoV2 Variants - Wild, Kappa, Delta, Omicron

About

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.

History

Apr 2021 - Development of assay of emergent SARS-CoV-2 variants.
Mar 2021 - ISO/IEC 17025 accreditation.
Feb 2021 - 13 Crore 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.
May 2020 - SARS-CoV-2 based immunogenicity assay development in newly built BSL-3 facility.
Feb 2019 - Establishment of NIBEC facilit - Mar 2020.
Feb 2019 - 16 Crore Grant Approval under i3 program (NBM, DBT India).

Facility

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

All technical managers are trained for Good Clinical Laboratory Practice (GCLP)

Supervision of routine laboratory activity and reporting of work to lab manager, in compliance with analytical study plan, standard operating procedures and any associated work instruction

Ms. Prajakta Rane

M.Sc. Virology

Ms. Urmi Majumdar

M.Sc. Virology

Mr. Shambhu Pisal

M.Sc. Biotechnology

Ms. Amita Kasana

M.Sc. Biotechnology

Project Managers

Analytical Project Managers

All APMs are trained for Good Clinical Laboratory Practice (GCLP), Laboratory Quality Management System and Internal Audit as per ISO/IEC:2017 Standard.

Dr. Shubham Shrivastava

Ph.D (Biotechnology)

Dr. Ruta Kulkarni

Ph.D (Biotechnology)

Dr. Rashmi Virkar

Ph.D (Biotechnology)

Dr. Archana Munje

Ph.D (Biotechnology)

Dr. Sudha Ramkumar

Ph.D (Microbiology)

Staff

Technical Staff

All technical staffs are trained for Good Clinical Laboratory Practice (GCLP) and demonstrated technical competency for the specialized tests

Ms. Aabha Thite

MSc Virology

Ms. Abhilasha Kadu

MSc Biotechnology

Ms. Anuradha Patil

MSc Virology

Ms. Jayshree Bhagat

MSc Biotechnology

Ms. Kajal Phadtare

MSc Microbiology

Mr. Manoj Kadam

BSc Biotechnology

Mr. Omkar Kalaje

MSc Biotechnology

Ms. Rajkanya Toge

MSc Biotechnology

Ms. Sanika Ghayal

MSc Cancer Biology

Ms. Sawani Karandikar

MSc Microbiology

Mr. Shubham Kadlag

MSc Zoology

Ms. Shweta Kulkarni

MSc Biotechnology

Mr. Sourabh Pandharmise

MSc Virology

Ms. Tejashree Shendage

MSc Biotechnology

Support Services Staff

Mr. Amol Ohol

Member

Mr. Mahesh Humbe

Member

Ms. Meghana Walke

BSc Microbiology, DMLT

Mrs. Prajakta Jaswante

Purchase Officer

Mr. Rahul Kadu

MAINTENANCE ENGINEER, BE Electronics and Telecommunications

Mr. Rahul Patil

IT OFFICER AND ARCHIVIST, MSc Statistics Telecommunications

Mr. Tushar Bhosale

IT AND EHS-OFFICER, BCA

Mr. Tushar Dalvi

BSc Paramedical, DMLT

Mr. Tushar Shinde

BSc Paramedical, DMLT

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

Contact Us

Mail Us @ : services.nibec @bharatividyapeeth.edu

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