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National Institute of Biologicals

(राष्ट्रीय जैविक संस्थान)

Ministry of Health & Family Welfare, Government of India

स्वास्थ्य एवं परिवार कल्याण मंत्रालय,भारत सरकार
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Participation in Collaborative Studies of 

National & International Organizations

 

S.No.  Name of Study  Collaborator  Period of Study Name of NIB Laboratory Status
1. National Reference Standard preparation of Filgrastim 6 Laboratories (NIB, Filgrastim Stakeholders, & USP) 2015 - 2017 Recombinant Product Laboratory Candidate selection is underway
2. National Reference Standard preparation of Insulin Lispro 6 Laboratories (NIB, Insulin Stakeholders, IPC & USP) 2015 - 2017 Recombinant Product Laboratory Report compiled
3. National Reference Standard preparation of insulin Lispro 6 Laboratories (NIB, Insulin Stakeholders, IPC & USP) 2015 - 2017 Recombinant Product Laboratory Results are received from all labs. Preliminary Report compiled
4. The 1st WHO reference reagent for the biological activities of Rituximab-like monoclonal antibodies NIBSC, UK March 2016 to May 2016 Therapeutic Monoclonal Antibody Laboratory Samples under Evaluation
5. Development of Techniques and Reagents for Quality Control of Clinically important Indigenous Allergen Extracts ( Cockroach and Moth) 1. Dr. Achla Prasad, S-I

2. Dr. M.K. Agarwal

3. Dr. Deepak Talwar

Ongoing work on allergen standardisation undertaken at NIB Allergen Testing Laboratory Work in Progress
6. Method verification studies for development of IP monograph for rituximab drug product and drug substance Indigenous manufacturers, IPC & CDSCO March to July 2015 Therapeutic Monoclonal Antibody Laboratory Ongoing
7. Method verification studies for development of IP monograph for Rituximab drug product and drug substance Manufacturers of Rituximab Jan - July

2015

Therapeutic Monoclonal Antibody Laboratory Phase - I study Initiated
8. WHO Collaborative Study to assess the suitability of a candidate 3rd WHO IS for HBsAg for use in serology assays NIBSC, U.K Dec, 2013 Infection Diagnostics Lab Completed.

Report published in Expert Committee on Biological Standardization Geneva 13 to 17 October 2014 with study coordinator Dr. Dianna Wilkinson WHO/BS/2014.2241

 

9. WHO Collaborative Study to assess the suitability of a candidate 3rd WHO is for HBsAg for use in serology assays NIBSC, U.K Dec, 2013 Infection Diagnostics Lab Study completed, Result awaited
10. Chemometric tool to analyze consistency of quality of Insulin samples IIT - Delhi

Dr. Anurag Rathore, Department of Chemical Engineering

Jun 2012-

Mar 2013

 

Recombinant Product  Lab
  • Feb 2013, July 2013 Draft report to be reviewed

11. WHO Collaborative study for 1st International Standard (IS) for Human Insulin NIBSC - Potters Bar U.K.

Dr. Chris Burns,

Endocrinology,

Biotherapeutics

Nov 27, 2012 - Jan 29, 2013 Recombinant Product  Lab Preliminary report in Process

 5 analytical test- LOD, Zn, RP, Potency, Nitrogen on Insulin API & candidate standard

12. WHO Collaborative study for 1st International Standard (IS) for Human Pegylated G-CSF NIBSC - Potters Bar U.K.

Dr. Meenu Wadhwa, Cytokines & Growth Factors section

Jan 10, 2013 - Feb 27, 2013 Recombinant Product  Lab Study Completed Report received June 2013

 

updates

 


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