Anita Krishnan

Assistant Director and Head Analytical, R&D, Lupin limited (Biotech Division), Pune
Anita Krishnan headshot

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
  • “Comprehensive analytical data justifying the impact of differences along with tailored clinical investigation will be key to biosimilar development in the future.”

Type of organization

Lupin limited is a fully integrated generic pharmaceutical company, the 4th largest by market capitalization, in the global arena.


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
  • “Our activity in personalized medicine in oncology has dramatically increased.”