Research Facility : BIOREPOSITORY

About us

The biorepository facility at the NCR Biotech Science Cluster is one of the largest and most varied research bioresource centre in India. The biorepository facility was established in 2015 to provide support to the DBT funded pregnancy cohort study - ”Interdisciplinary Group of Advanced Research Birth Outcomes, a DBT India Initiative (GARBH-INI)” at THSTI. In 2019, it was identified as a separate platform in the Translational Research Program (TRP) with a mandate to expand to other programs in the NCR Biotech Science Cluster and beyond. It hosts a wide array of biospecimen with detailed clinical and demographic information collected under various programs. 

In 2020, the biorepository facility at the NCR Biotech Science Cluster was notified as one in the network biorepositories of National COVID-19 bioresource of well-phenotyped clinical samples by Govt. of India. 

Currently, biorepository facility archives > 1.4 million varied biospecimens from health/disease-based longitudinal cohorts for biomarker development/ validation and for seroprevalence studies (blood, serum, plasma, urine, saliva, placental tissue, NP/OP swabs, DNA & PBMCs etc.). The team facilitates the requesters on the study design based on sample availability and study objectives. All participant IDs are de-identified by the use of Unique Identification Code (UIC) and the archived biospecimen are also tagged with alphanumeric identifiers. 

The facility acts as the custodian of the samples archived under various studies and has developed and implemented a structured access process. The sample access requests received are evaluated for their scientific merit and public health implications by study specific access committees and domain experts. 

Objectives under each program (word limit: 100 words/objective) 

1. Inter-Institutional program for Maternal, Neonatal and Infant Sciences: interdisciplinary Group for Advanced Research on BirtH outcome- DBT India Initiative (GARBH-Ini Phase II):

  • As a Department of Biotechnology (DBT) funded program Garbhini, initiated as a hospital-based cohort of pregnant women at a district hospital in Gurugram, Haryana, (GCH) a secondary-care hospital that serves a rural and semi urban population of 1.5 million in the Gurugram district in Haryana. Women are enrolled within the first < 20 weeks of their pregnancy and followed up several times through delivery and once during the postpartum period. The primary outcome assessed in this study is Preterm Birth (PTB). Serial biospecimens are being collected across pregnancy, delivery and post-delivery along with the epidemiological data collection. To discover biological determinants of disease for novel therapeutic targets utilizing the high quality homogeneously collected human biospecimen with well-characterized clinical and environmental information.
  • BRF has collected and processed biological samples from 10714 pregnant women enrolled and followed longitudinally till delivery at different trimesters and post-partum. A total of ~ 100700 samples have been collected longitudinally and stored as ~13,00,000 aliquots that consist of various sample types namely, maternal high vaginal swab lysates, sera, plasma, urine, placental tissue, placental membranes, umbilical cord, cord blood sera, plasma and neonatal heel prick samples as dried blood spots.  ~ 43314 biospecimens have been retrieved for the completion of different research objectives that have resulted in peer reviewed publications. 

2. Gall Bladder Cancer (GBC) :

  • Gall Bladder Cancer biobank has been developed to collect clinico-pathological data (demography, treatment patterns, therapeutic outcomes) and bile/tissue samples from registered patients with molecular profiling/microbial data. These phenotyped samples have also been studied for identifying the association between gall-bladder cancer and microbial infection. Biospecimen (gall bladder tissue and bile fluid) from 32 participants have been collected and archived. These biospecimen have been characterized for molecular pathways related to gall bladder cancer and microbial inhabitants.

3. Post-Gestational Diabetes Mellitus (GDM) cohort:

  • This interventional cohort has been initiated at the Post-GDM clinic, Department of Endocrinology, AIIMS to uncover the metabolites associated with dysglycemia (prediabetes/diabetes) in Indian women with prior history of GDM. Sera and plasma samples (n=9,500 aliquots) from 950 participants have been collected and biobanked.

4. Pediatric Renal Biology Program: Research on Nephrotic Syndrome:

  • Pediatric Renal Biology Program is a multi-centre collaboration between THSTI and AIIMS for biobanking samples for research on nephrotic syndrome to characterize the burden of monogenic nephrotic syndrome in India including discovery of new genetic variants that may cause this condition or act as disease modifiers. 
  • Under this program, sera, plasma, DNA and urine samples have been collected from 1020 participants longitudinally across three hospitals and archived in ~ 31,000 aliquots.

5. DBT's Resource of Indian Vaccine Epidemiology Network (DRIVEN 2020)

  • Under the National Biopharma Mission and DBT’s Resource of Indian Vaccine Epidemiology Network (DRIVEN 2020) has established a serial sero-surveillance study to monitor the trend of SARS-CoV-2, Dengue and Chikungunya infection transmission in the general population, India. Sera samples from ~ 22633 participants collected under this serial sero-surveillance study to monitor the trend of SARS-CoV-2, dengue and chikungunya infection transmission rates in the general population in India have been archived. The facility archives 92132 aliquots that have been collected from four different states across the country.

6. Indian SARS-CoV-2 Consortium on Genetics (INSACOG)

  • The Indian SARS-CoV-2 Genomics Consortium (INSACOG) is a multi- laboratory, Pan-India network to monitor genomic variations in the SARS-CoV-2 by sentinel sequencing effort. This network carries out whole genome sequencing of SARS-CoV-2 virus across India to understand how the virus spreads and evolves.
  • As a part of the INSACOG, ~ 4500 NP/OP swabs from COVID-19 positive participants all over India have been collected and archived for monitoring of genomic variations in SARS CoV-2 virus and tracking of VOCs and VOIs in the community. 

7.DBT COVID-19 consortia: 

  • DBT COVID-19 consortium was initiated in March 2020 with the primary objective to study in depth, the SARS-COV2 infection, its clinical progression  & recovery patterns. Studies on longitudinal host immune responses in the Indian population and further use of this resource for developing effective diagnostic and therapeutic products for the disease are a few of the objectives that are being fulfilled using this rich resource.
  • Venous blood and NP/OP swabs have been collected longitudinally from 8450 COVID-19 positive/negative participants. Sera/plasma and peripheral blood mononuclear cells (PBMCs) are being isolated and stored along with its associated clinical data at the biorepository. The number of enrolled participants and different types of bioresources available from them are summarized in Figure.

 

 Vision & Mission


Mission: To establish a high-quality reliable resource of a wide-range of biospecimen for regulated use in new technology/ product development in academia and industry to facilitate translational research in both clinical and basic sciences globally.

Vision: To adhere to the best practices in providing reliable, retrievable, high-quality biological resources and to facilitate capacity building in biobanking at a national level by means of training, collaboration and knowledge exchange. 

Quality Policy

Biorepository Facility (BRF), THSTI is committed to: 

  • Being compliant with the law and applicable ethical, societal, and professional standards.
  • Providing well characterized, high-quality biospecimen and the best, reliable biorepository services.
  • Implementing and improving a reliable traceability system.
  • Promoting the quality management system and ensuring its continual improvement through internal audits, management re-views, along with corrective and preventive actions.

Quality objectives

  • To meet or supersede customer needs by delivering high-quality bioresources along with associated data through a well-structured governance process.
  • Ensure requesters satisfaction through a feedback mechanism.
  • To implement a quality management system that ensures compliance with ISO 20387: 2018 standard and other International Standards.
  • To ensure accurate and reliable biorepository services. 
  • To ensure timely delivery of bioresources at optimal temperatures to the interested approved parties. 
  • To emphasize on prevention of non-conformance rather than detection.
  • To ensure compliance with statutory obligations, environmental and safety regulations.
  • To maintain highest professional demeanour.

Collaborations

The Biorepository has established collaborations  with academia, hospitals  as well as private labs under various studies.

  • DBT COVID-19 Consortium
  • National Biopharma Mission
  • All India Institute of Medical Sciences, New Delhi
  • National Institute of Immunology
  • Makunda Christian Leprosy and General Hospital
  • Christian Christian Medical College, Vellore
  • Global Immunology and Immune Sequencing for Epidemic Response (GIISER)
  • Dr. Dangs Lab, New Delhi
  • Medanta Hospital, Gurugram
  • ESIC Medical College and Hospital, Faridabad
  • Lok Nayak Jai Prakash Narayan (LNJP) Hospital, New Delhi

Infrastructure

The Biorepository is housed in a 2966 square feet facility, which has been established as per ISBER guidelines. Six separate rooms have been created to segregate different activities namely accessioning, nucleic acid isolation, biospecimen archival, COVID-19 biospecimen processing, PBMC isolation and documentation. All equipment is calibrated and validated as per the requirements of ISO 17025: 2017 standard from an accredited third party agency.

The facility is equipped with -80°C deep freezers (n=34), -20°C freezers (n=1), 5±3°C Refrigerator (n=2), Liquid Nitrogen Storage Tanks (n=9), Cryoshippers (n=4) and other biospecimen processing equipment such as  Biosafety cabinets (n=3), Centrifuges (n=3), Incubators (n=2) & Spectrophotometer (n=1).

Services

NCR Biotech Science Cluster Biorepository provides services for biospecimen collection, processing & storage (Deep freezer/Liquid nitrogen/Room temperature) as per need. Under dissemination of knowledge, the facility provides training on  collection, processing of varied samples. They have also trained interested researchers on setting up labs at the study sites and biorepository as per the best practices.
Biospecimen Processing Facility

  • Peripheral blood mononuclear cell (PBMC) isolation from whole blood
  • Nucleic acid (DNA) extraction sera and plasma preparation from whole blood 

Biospecimen Archival Facility
The facility has the capacity to store 2 ml aliquots of at least 1.6 million biospecimens. It is equipped with 34 deep freezers (-80°C) and 9 liquid nitrogen containers for archival of at their optimum temperatures.
Training of Manpower on lab processing of samples and biorepository guidelines
The facility is supporting national development efforts by training participants in the area of biorepository management from industry, academia, biobanks etc.

 

Contact Details

Dr. Pallavi Kshetrapal

 pallavi.kshetrapal@thsti.res.in
0129- 2876353