| S.No. |
Name of Study |
Collaborator |
Period of Study |
Name of NIB Laboratory |
Status |
| 1. |
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
|
| 2 |
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
|
| 3 |
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
|
| 4 |
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 |
|
| 5 |
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
|
| 6 |
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
|
