Screen Reader Access   

Bioassay Laboratory

Under the Translational Research Program, we are establishing a bioassay laboratory for the clinical development of vaccines and biologicals. The bioassay laboratory is intended to meet the global standards in Good Clinical Laboratory Practice (GCLP) and will be applying for accreditation by National Accreditation Board for testing and calibration Laboratories (NABL) for vaccine development and testing.

As part of our phase I activities, a laboratory measuring around 2000 sq. ft. has been set up as per the guidelines of WHO and NABL. Eight separate rooms have been created to maintain unidirectional workflow and segregate the activities such as flow cytometry, serology, reagent preparation, nucleic acid isolation, template addition, PCR and post-PCR rooms and animal cell culture for virus cultivation. All the equipment has been calibrated and validated as per the NABL requirements.

Assays: The scope of assays as part of phase I activities is given below:

Type of samples examined/tested

Specific tests/examination performed

Human serum

Dengue NS1, Dengue IgG and IgM ELISA

Human serum

Dengue plaque reduction neutralization test (PRNT)

Human whole blood/serum

Dengue viremia

Human whole blood/serum

Dengue serotyping

Quality Policy:

THSTI Bioassay Laboratory is committed to achieve highest customer satisfaction through continual improvements, highest ethical standards and strive for achieving greater public good. This will be achieved by our total commitment to:

  • Comply with the requirements of ISO/IEC 17025:2017 and NABL 165 thereby assuring accurate and reliable test results.
  • Maintain impartiality, integrity, and confidentiality of all laboratory activities.
  • Ensure that all our activities are safe for consumers, employees, and environment.

Quality Objectives:

  • Quality practices that are communicated within the laboratory are understood and adhered by all employees.
  • To ensure accurate and reliable testing services.
  • To ensure delivery of test reports on time, every time.
  • To meet and exceed customer satisfaction at all levels.
  • To implement internal quality checks to improve accuracy and reliability.
  • To achieve good performance in Inter Laboratory Comparison/ Proficiency Testing.
  • To maintain good performance of laboratory equipment.
  • To fulfill the requirements of the ISO/IEC17025:2017 Standard.
  • To maintain the highest professional demeanor.


Personnel:

Dr. Guruprasad R. Medigeshi
Laboratory Director
gmedigeshi@thsti.res.in
0129-2876381


Dr. Guruprasad is an Associate Professor at THSTI since Dec 2009. He is a PhD from Georg-August University, Germany and has post-doctoral training from Oregon Health Science University, Portland, Oregon, USA. He is leading a research group with primary focus on mosquito-borne viruses such as dengue virus, Japanese encephalitis virus and Chikungunya. His research interests include innate immune response to dengue infection, effect of virus infection on epithelial and endothelial barrier functions and characterizing the circulating virus isolates in India. He is currently leading the efforts to establish a NABL-accredited bioassay laboratory for vaccine development at THSTI as a national facility.

Dr. Nagender Rao Rameshwaram
Technical Manager
nagender@thsti.res.in
0129-2876384

  • M.Sc. Biotechnology, University of Hyderabad, Hyderabad, India
  • Ph.D. Biochemistry, University of Hyderabad, Hyderabad, India
  • He has more than 11 years of research/work experience in the academic and industry settings from national and international institutes/companies:
    • University of Ghent, Belgium
    • Center for Cellular and Molecular Biology, India
    • Centre for DNA Fingerprinting & Diagnostics, India
    • University of Greifswald, Germany
    • University of Gothenburg, Sweden
    • Dr. Reddy's Laboratories, India

He joined THSTI in August 2019 and is currently associated with the bioassay lab establishment by supervising the technical team.

Mr. Zafar Abbas
Quality Assurance Manager
bioassay_qm@thsti.res.in
0129-2876381

  • M.Sc. Biotechnology, Integral University, Lucknow, India
  • PG-Diploma in Quality Assurance and Quality Control from IGMPI, New Delhi, India
  • He has more than 5 years of working experience at National Institute of Biologicals (a National Control Laboratory).
  • He has faced audits by NABL for the requirements of reassessment, surveillance for continuous accreditation system as per ISO 17025:2005 compliance, by National Regulatory Agency (NRA-CDSCO) for Notification of Central Dugs Laboratory and by WHO for strengthening National Regulatory Agency (NRA) for Vaccine testing in India at NIB.
  • He is working on the establishment of Laboratory Quality Management System as per the requirements of ISO/IEC 17025:2017 Standard for NABL accreditation.
Trainings:
  • ISO/IEC 17025:2017
  • ISO 15189:2012
  • ILC-PT
  • GLP
  • GCLP
  • Internal Auditor ISO 9001 QMS, OHSAS 18001 and ISO 14001 EMS

Megha Singh Chauhan
Lab Manager
megha.chauhan@thsti.res.in
0129-2876382

  • M.Sc. - Microbiology, Maharshi Dayanand Saraswati University, Ajmer, India
  • Diploma - Biotechnology, University of Rajasthan, Jaipur, India
  • She has more than 5 years of experience in microbiological analysis of water according to IS: 14543, IS: 10500, IS: 13428 and food samples as per IS and FSSAI using modern analytical techniques in NABL, BIS & FSSAI-accredited laboratory.
Trainings:
  • IS/ISO/IEC: 17025:2017
  • GFLP

Sharanabasava
Assistant Vaccine Technologist
sharan.patil@thsti.res.in
0129-2876382

  • M. Sc. - Biochemistry, Gulbarga University, Karnataka, India.
  • He has 18 years of work experience in the nationally reputed institutes: National Centre for Cell Science - Pune.
  • Indian Institute of Technology - Guwahati.
  • Translational Health Science and Technology Institute, Faridabad
Trainings:
  • ISO 17025:2017
  • ISO 15189:2012
  • Measurement Uncertainty
  • GLP and GCLP

He has worked for Phase-III Clinical Trial for Oral Rotavirus Vaccine (ORV) 116E and is currently involved in the optimization and validations of assays for dengue serum specimens.

Madhu Pareek
Technical officer - I
madhu@thsti.res.in
0129-2876382

  • Ph.D. Biotechnology, Bhavnagar University, Bhavnagar Gujarat, India
Trainings:
  • ISO 15189:2012
  • ISO 17025:2017
  • GLP
  • GCLP

She is involved in multiple academic research projects since 2010 and is currently involved in optimization and validations of assays for dengue.

Imran Khan
Laboratory Technician
imran.khan@thsti.res.in
0129-2876382

  • M.Sc. – Biochemistry, UPRTOU, Allahabad, India
  • Diploma in Medical Lab Technology, IMA, New Delhi, India
Trainings:
  • ISO 17025:2017
  • GLP
  • GCLP

He has worked with the Batra Hospital and Medical Research Center, Quest Diagnostics and Indraprastha Apollo Hospitals and participated in the JCI, CAP, NABL and NABH audits.

He has worked for the phase-III ROTAVAC vaccine clinical trials and is currently establishing serological assays for dengue.

Mani Ram
Laboratory Attendant
maniramns1@gmail.com
0129-2876383

  • Diploma in Medical Laboratory Technology from NIMS-University, India
  • He is working for Bioassay Laboratory since April 2018
  • He has worked for Phase-III Vaccine Clinical Trial for Oral Rotavirus Vaccine (ORV) 116E and is involved in catering to the basic necessities of the bioassay laboratory for smooth functioning.