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Interactive Research School For Health Affairs (IRSHA), Pune

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ICMR Centre for Advanced Research (CAR)


About

About

The Indian Council of Medical Research (ICMR), Government of India has awarded a Centre for Advanced Research (CAR) to the Mother and Child Health department of Interactive Research School for Health Affairs (IRSHA), a constituent unit of Bharati Vidyapeeth University with a grant of over Rs 7.0 Crore.

This ICMR CAR REVAMP (Research Exploring Various Aspects and Mechanisms in Preeclampsia) study, the first of its kind in the country will help in early identification of pregnant women who are at risk of developing preeclampsia. The prospective design of the study for the first time will establish the role of LCPUFA in understanding the underlying biochemical and molecular mechanisms involved in preeclampsia and their association with developmental programming in children.

The study is being carried out at the Interactive Research School for Health Affairs (IRSHA) in collaboration with Bharati Medical College and Hospital, Pune; Gupte Hospital and Research Centre, Pune; and Council of Scientific and Industrial Research-Centre for Cellular and Molecular Biology (CSIR-CCMB), Hyderabad. The current study is ongoing and the total duration of the study is five years i.e. from 31st March 2017 - 30th March 2022.

Introduction

Introduction

Preeclampsia is a major cause of maternal, fetal and neonatal morbidity and mortality, particularly in developing countries. Considering the burden of preeclampsia and its associated complications, it is important to understand the underlying risk factors and mechanisms involved in its etiology. There is considerable interest in the potential for dietary long chain polyunsaturated fatty acids (LCPUFA) as a therapeutic intervention to prevent preeclampsia, as they are involved in angiogenesis, oxidative stress, and inflammatory pathways. The study hypothesizes that LCPUFA and one carbon metabolite status among Indian women play a causal role in the etiology of preeclampsia, mediated by changes in oxidative stress and growth factors which alter placental development. This study proposes to examine the associations of maternal LCPUFA and one carbon micronutrient status in early gestation with clinical outcome in preeclampsia and to understand the underlying key biochemical and molecular mechanisms.

The ICMR Centre for Advanced Research (CAR) study follows a cohort of pregnant women from early pregnancy until delivery to examine longitudinally the associations of maternal LCPUFA with clinical outcome in preeclampsia. A multisite centre for advanced research was established and pregnant women coming to Bharati hospital and Gupte hospital, Pune, India for their first antenatal visit are recruited and followed up at 11-14 weeks, 18-22 weeks, 26-28 weeks, and at delivery. Their personal, obstetric, clinical, and family history are recorded. Anthropometric measures (height, weight), food frequency questionnaire (FFQ), physical activity, socioeconomic status, fetal ultrasonography, and color Doppler measures are recorded at different time points across gestation. Maternal blood at all time points, cord blood, and placenta at delivery are collected, processed and stored at -80°C. The children’s anthropometry is assessed serially up to the age of 2 years, when their neurodevelopmental scores will be assessed.

The Outcome of Proposed Study

The Outcome of Proposed Study

The present study will be useful in:

  • Development/validation of biomarkers for early prediction of preeclampsia.
  • Providing information on mechanistic aspects of preeclampsia.
  • Understanding the neurodevelopmental outcome of children born to women with preeclampsia.
  • Correlation of USG and color Doppler findings and histopathological examination of placenta.
  • Establishing a biorepository: The establishment of a biorepository will provide an invaluable resource to be shared with other investigators for future research on other factors influencing adverse pregnancy outcomes.

Objectives

Objectives

The REVAMP study proposes to examine the associations of maternal LCPUFA and one carbon micronutrient status in early gestation with clinical outcome in preeclampsia and to understand the underlying key biochemical and molecular mechanisms. It consists of 4 sub-projects:

Project 1: Longitudinal changes in metabolites of the one carbon cycle in preeclampsia

The study will examine baseline levels (in early pregnancy) at 11–14 weeks of gestation (visit 1 –V1) and changes across gestation [18–22 weeks (visit 2 – V2), 26–28 weeks (visit 3 – V3) and at delivery] in components of the one carbon cycle [(folate, vitamin B12, methionine, glutathione, homocysteine, SAM, S-adenosylhomocysteine (SAH)] from early pregnancy until delivery, and placental global DNA methylation levels. It will also examine the relationship of altered one carbon metabolism to methylation potential (SAM: SAH ratio) in the placenta. Furthermore, these changes in the one carbon cycle metabolites will be associated with dietary and lifestyle factors, USG and color Doppler measures.

Project 2: Role of oxidative stress and metabolites of LCPUFA metabolic pathway in preeclampsia

This study will examine levels of oxidative stress markers (protein carbonyl, 8- hydroxyl (OH) guanidine, malondialdehyde (MDA); LCPUFA status and their bioactive metabolites (thromboxane B2; prostaglandin E2) at baseline and across gestation. In addition, measurements of placental phospholipids and gene expression and DNA methylation patterns of PPAR gamma, PEMT, and DNA methyl transferase (DNMT) genes from the placenta will be undertaken.

Project 3: Growth factors and regulation of their gene expression in preeclampsia

This study will analyze levels of angiogenic growth factors – [VEGF, PlGF, sFlt-1, sEng], HIF-1, neurotrophins – [brain derived neurotrophic factor (BDNF), nerve growth factor (NGF) and their receptors] across gestation. It will also examine the associations between altered expression of growth factors involved in placental development, their regulation by methylation as a response to altered one carbon metabolism, and placental histopathological changes. These molecular as well as structural changes in the placenta will further be correlated with clinical parameters for better understanding the etiopathology of preeclampsia.

Project 4: Association of maternal nutrition, biochemical and epigenetic changes with anthropometry and developmental changes in children born to mothers with preeclampsia

This study aims to follow-up the babies for their postnatal anthropometric measurements at birth, 6, 10, and 14 weeks, 6, 9, 12, 15, 18, and 24 months and developmental scales at 2 years of age. The associations of maternal nutrition, biochemical and epigenetic changes, USG and Doppler measures with anthropometry and developmental scores in children will also be undertaken to better understand the mechanisms involved in the fetal programming of developmental disorders in children born to mothers with preeclampsia.

Figure 1 depicts the connectivity between the various objectives.

Key questions

The proposed study will answer the following questions:

  • Do levels of LCPUFA and their metabolites, and one carbon nutrients, differ in early pregnancy between women who do and do not go on to develop preeclampsia?
  • Is there evidence that these differences are dietary in origin?
  • Do the molecular and biochemical analyzes provide a plausible mechanistic pathway to explain the pathophysiology of preeclampsia?
  • Do the early pregnancy biomarkers identified provide a clinically useful prediction of later preeclampsia?
  • Does the postnatal growth and cognitive development of children of women with preeclampsia differ from that of controls?
  • Are these differences in the children explained by changes in growth factors?

Mission

Mission

Reducing maternal and child morbidity and mortality by exploring mechanisms involved in preeclampsia.

Major Activities

Major Activities

Meetings with Collaborators and Advisers

Prof. Caroline Fall (University of Southampton)

Dr. K. Kumaran (MRC Lifecourse Epidemiology Unit & Holdsworth Memorial Hospital, Mysore)

Dr. Giriraj Chandak (CSIR- Centre for Cellular and Molecular Biology (CSIR-CCMB), Hyderabad)


Discussion with Clinicians from Bharati Hospital and Gupte Hospital


Training in Administering Questionnaires

Staff Trained in Administering Nutritional Questionnaires at National Institute of Nutrition (NIN), Hyderabad

Staff Trained in Administering Nutritional Questionnaires at National Institute of Nutrition (NIN), Hyderabad

Staff Trained in Administering Standard of Living Index (SLI) and Physical Activity Questionnaire at IRSHA


Training in Placental Histopathology

Training at St. John’s Research Institute, Bangalore


Staff Counseling the Patients and Administering Various Questionnaires at Bharati Hospital and Gupte Hospital



Follow up Meetings with all the Collaborators


Yearly Advisory Meeting


Establishment of Biorepository

Laboratory Analysis

1. Gas Chromatography (GC)

Fatty acid analysis using GC

2. ELISA

Estimation of protein levels of growth factors using ELISA

3. PCR and Real Time-PCR

mRNA expression of various genes using RT-PCR

4. High Performance Liquid Chromatography (HPLC)

S-Adenosyl Methionine (SAM) and S-Adenosyl-L-Homocysteine (SAH) estimations using HPLC

5. Ultracentrifuge

Isolation of plasma membranes from placental homogenates

Management team and Staff

Management team

  • Dr. Sadhana Joshi, Professor and Head
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  • Dr. Nisha S. Wadhwani, Scientist “B”,
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ICMR CAR Staff

  • Ms. Madhura Sarda, Psychologist,
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  • Ms. Shweta D Madiwale, Research Assistant,
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  • Ms. Rutuja Tope, Nutritionist,
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  • Ms. Sakshi Selukar, Nutritionist,
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  • Mr. Sagar Bhosale, Social Worker,
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  • Ms. Prachi Joshi, Social Worker,
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  • Ms. Anupam Poddar, Lab Assistant,
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  • Ms. Aditi Mane, Lab Assistant,
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  • Ms. Aditi Godhamgaonkar, Lab Assistant,
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  • Ms. Nikita Joshi, Lab Assistant,
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  • Ms. Juilee Deshpande, Lab Assistant,
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  • Ms. Aboli Ballal, Lab Assistant,
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  • Mr. Mahesh Funde, Data Entry Operator,
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  • Mr. Nganthoi Elangbam, Data Entry Operator,
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  • Mr. Aniket Shelar, Field Attendant,
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Contact us

ICMR- Centre for Advanced Research (CAR)

Interactive Research School for Health Affairs (IRSHA),
Bharati Vidyapeeth (Deemed to be University),
Pune-Satara Road, Dhankawadi,
Pune 4110043,
Maharashtra, India
Tel No.:- 020-24366920
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National Immunogenicity & Biologics Evaluation

Bharati Vidyapeeth (Deemed to be University),
Pune-Satara Road, Dhankawadi,
Pune 4110043,
Maharashtra, India
Tel No.:- 020-24366920
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Environment, Health and Safety (EHS)


EHS Policy

EHS Policy Statement

Environment, Health and Safety

Interactive Research School for Health Affairs (IRSHA)
Bharati Vidyapeeth (deemed to be University), Pune

The mission of IRSHA is to conduct research and development, to provide maximum health benefit to people with safe and environmentally friendly approach. IRSHA attaches greatest value to its employees, research students, trainees and stakeholders, contractors, patients and communities. IRSHA further believes that safety and health of its personnel and public are a matter of paramount concern and accords it the same importance and priority as for research and development. IRSHA strives to prevent all possible accidents, incidents, injuries and occupational illnesses and shall make continuous and dedicated efforts to protect the environment.

IRSHA is obligated to:

Promote the research work in a manner that protects the safety and health of its personnel and the public; give priority to EHS in the planning and execution of the research work and related activities of the institute, and maintain compliance with all relevant and applicable state/central regulations.

In support of this policy, IRSHA commits to:

  1. Work continuously to improve the efficiency and effective performance of the EHS management system of the institute.
  2. Conduct the research activities and process development to prevent or minimize the impact on the environment, health and safety of all personnel and public.
  3. Create awareness, skill and competence to develop the required level of knowledge and skills in all personnel through training and internal communication.
  4. Maintain good housekeeping practices in the institute premises.
  5. Eliminate, minimize and/or control adverse environmental impacts by adopting appropriate technologies and best EHS management practices at all levels of functions.
  6. Prevent workplace injuries and illnesses, environmental incidents, and property losses or damage.
  7. Arrange for the safe use, handling, storage and transport of materials and hazardous substances;
  8. Make appropriate arrangements to assess and control the risks associated with work activities undertaken at the institute; and
  9. Maintain EHS policy, guidance and procedures consistent with current best practice for health and safety management through monitoring and regular review.

While the ultimate responsibility for the safety and environmental health rests with the Director, IRSHA, responsibility is devolved to all the scientists, Project Leaders, technical and administrative staff to ensure adequate implementation of the institute EHS policy in their respective areas of responsibilities and activities.


Dr. A. C. Mishra
Director

Environment, Health and Safety Risk Management Plan

Environment, Health and Safety Risk Management Plan


1. Environmental Impact and risk mitigation

Risk Project Specific Risk Potential Impact Mitigation Steps
Air Pollution Minimal risk Inadvertent air contamination of virus Outgoing air from critical lab passes through HEPA filters of BSL-2 and BSL-3 Labs
Water Pollution Minimal risk Inadvertent contamination of water All liquid waste from critical area treated in effluent treatment plant(ETP)
Chemical waste Marginal impact Some chemicals are carcinogenic and might induce adverse impact on health By following the process specified for the chemical disposal provided by manufacturers.
Biological Waste

 

Minimal risk Inadvertent contamination with virus, risk of infection to staff and community Waste management system (Annexure A)
Heavy metals, Radiation wastes, destruction of surrounding ecosystem Minimal risk Project implementation aspects will not create any adverse heavy metals waste. Not required

2. Occupational Health and Safety and risk mitigation

Risk Project Specific Risk Potential Impact Mitigation Steps
Heat Hazards Minimal risk Burn related to seam of autoclave All necessary procedures are in place to prevent heat associated hazards particularly in SOP of autoclaves, washing areas etc
Chemical Hazards Minimal risk Injuries Chemicals are stored in ventilated cup boards and aliquots are prepared in fume hoods available on all the floors
Fire Hazards Minimal risk Injuries, property loss Fire safety equipment
Pathogenic and biological hazards Marginal impact There will be chance of infection with virus Appropriate Biosafety precautions are taken by all workers. Infectious organisms are handled in Biosafety cabinets following SOPs
Process safety Minimal risk There may be chance of contamination with virus All work is done in BSL-2 lab, following Biosafety guidelines 
Radiological and noise hazard Minimal risk Project implementation will not cause any radiological hazards. Not applicable

3. Community Health and Safety and risk Mitigation

Risk Project Specific Risk Potential Impact Mitigation Steps
Transport of hazardous material Minimum minimum As described in waste management system (Annexure A)
Emergency preparedness Plan Minimal Not much Onsite emergency plan, mock drills, communication system is in place
Communication with local community minimum Misunderstanding about the project in community Detailed information has been shared with Pune Municipal Corporation authorities and local community representatives)

Biomedical Waste Management and Disposal

The collection, transportation and disposal of biomedical waste generated as a result of various diagnostic and research requirements are carried out on a daily basis. The infectious waste that is produced is pre-treated on a daily basis (either chemically disinfected or autoclaved) at an institutional level and is handed over to PASSCO Pvt. Ltd. A PASSCO vehicle with GPRS tracking system transports the waste from the institute to their plant for further treatment. The infectious waste collected in yellow bag is incinerated at 800 oC while the waste collected in red bag is shredded or recycled or used in landfills. The sharps and glass material collected is chemically treated and used for landfill. Ash from incineration of biomedical waste is disposed off at a landfill.

  Category
Month Yellow Red Blue White Total weight
Sep. 2019 46.88 78.69 - - 125.57
Oct. 2019 71.93 83.84 - - 155.77
Nov. 2019 58.71 77.08 6.635 - 142.425
Dec. 2019 46.25 103.34 - - 149.59
Jan. 2020 68.17 138.54 - - 206.71
Feb. 2020 96.79 115.646 - - 212.436
Mar. 2020 56.766 37.575   - 94.341
April. 2020 48.16 0.803 - - 48.963
May. 2020 77.696 6.289 - - 83.985
June. 2020 37.045 10.04 - - 47.085
July. 2020 50.205 44.74 - - 94.945
Aug. 2020 104.262 29.345 - - 133.607
Sep. 2020 53.29 15.6 - - 68.89
Oct. 2020 136.775 52.085   6.005 194.865
Nov. 2020 107.135 32.572 - - 139.707
Dec. 2020 118.895 37.025   - 155.92
Total 1178.959 863.21 6.635 6.005 2054.809

Important Documents

Important Documents

Management team and Staff


Management team

  • Dr. A. C. Mishra, Director
  • Dr. Vidya Arankalle, Senior Scientist
  • Dr. Shubham Srivastava, Associate Professor

NIBEC Staff

  • Dr.Rekha Damle, Laboratory Manager,
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  • Dr.Archana Munje, Assistant Professor
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  • Dr. Sudha Ramkumar, Assistant Professor
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  • Dr. Suhas Mhaske, Assistant Professor
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  • Anamika Solaskar, Technical Assistant
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  • Shambhu Pisal, Technical Assistant
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  • Aniket Amlekar, Technical Assistant
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  • Prajakta Rane, Research Assistant
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  • Pravin Kore, Research Assistant
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  • Urmi Mujumdar, Research Assistant
  • Rahul Kadu, Maintenance Engineer
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  • Shital Nikhar, Quality Assurance Executive
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  • Tushar Bhosale, Technical Officer(EHS)
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  • Rahul Patil, Statistician
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Home About Mission R & D Testing Services Staff EHS Contact us

Major Activities


Research & Development

Globally, development of better methods for accurate assessment of vaccines employing different formats is pursued vigorously. NCIA proposes to keep pace with these developmental activities and engage in relevant innovative research.

For this, it is mandatory to carry out relevant research that will complement such testing, improve the current methods and look for additional tests/parameters that will be useful in vaccine/antiviral evaluation. Immune response of the vaccines against evolving Indian strains of pathogens is an important activity that will enhance the productivity and add value of national importance.

Testing Services

1. ELISA – (Dengue NS1/IgM/IgG)

To detect and quantitateantibodies generated following immunization during clinical trials of vaccines.

 
2. Plaque and Plaque Reduction Neutralization Test (PRNT) for Dengue & Chikungunya Viruses

To detectand quantitate serotype specific neutralizing Abs

 
3. Hemagglutination (HA) &Hemagglutination Inhibition (HI) Assays for influenza viruses

To subtype influenza virus isolates
To detect and quantitate HI titers against influenza viruses

 
4. PCR- Real time PCR

For diagnosis, serotyping and quantitation of viruses

 
5. Microneutralization assay

To detect and quantitate anti-influenza virus neutralizing antibodies

 
6. Flow Cytometry

For quantitation of immune cells, cell /virus-specific antigens,
Assessment of immune response following stimulation with recall antigens

 
7. Immunofluorescence assay

To detect and quantify Ag/ Abs









Mission


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

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.









National Immunogenicity & Biologics Evaluation Center

(A DBT-BIRAC initiative under National Biopharma Mission)

  • Vaccines save millions of lives around the world...

  • Vaccine development process is rigorous and time consuming...

  • Despite 50 years of research, our arsenal of antiviral drugs remains dangerously small...

  • Immunogenicity testing of vaccines in clinical trial is critical and challenging...

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.


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.