Anita Krishnan
Assistant Director and Head Analytical, R&D, Lupin limited (Biotech Division), Pune
Project goal
Develop characterization workflows for complex biopharmaceuticals through various stages of product development to enable drug approvals.
The solution
- To develop strong LC-MS/MS workflows to decipher various critical quality attributes (CQAs) such as glycan attributes, conjugation sites, disulphide linkages, in the protein of interest
- To characterize and quantify product related impurities
- To integrate LC-MS/MS data with data from other orthogonal methods to provide an overall picture
Biggest challenges right now
- Native high-resolution mass spectrometry of heavily glycosylated molecules
- Risk based development of powerful data mining software
- Regulatory friendly concise reporting of complex MS data
Outcomes of research
- Co-development of BioPharmaView™ Software (DSB analysis module)
- Superior sensitivity and high resolution of SCIEX TripleTOF® 5600+, enabled released N- and O glycan annotation and product related impurity characterization of complex biopharmaceuticals
- Strong characterization data package facilitated Global Business Development
Type of organization
Lupin limited is a fully integrated generic pharmaceutical company, the 4th largest by market capitalization, in the global arena.
Goals
Lupin works toward end-to-end biosimilar product development, manufacture, pre-clinical and clinical studies leading to regulatory filing globally.
SCIEX hardware
- TripleTOF® 4600 System
- TripleTOF® 5600+ System
SCIEX software
- Analyst® 1.6 and 1.7
- PeakView® 1.2 and 2.2
- BioPharmaView™ 1.0, 1.1, 1.2 and 2.0