| 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 |
|
| 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
|
