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