Differentiate Minor Difference of Protein Structure in Biosimilar and Reference Products Using High-Resolution Orbitrap LC-MS/MS

Structure Characterization and Differentiation of Biosimilar and Reference Products Using Unique Combination of Complementary Fragmentation Mechanisms Zhiqi Hao,1 Chen Li, 2 Shiaw-Lin Wu, 2,3 David M. Horn1 and Jonathan Josephs1 1 Thermo Fisher Scientific, San Jose, CA; 2BioAnalytix Inc, Cambridge,…

For bottom-up experiments, the monoclonal antibodyy Rituximab was denatured for 30 min in 7 M Urea and 50 mM Tris HCL at pH 8.00. The sample was reduced with 5 mM 37°C and alkylated by addition of 10 mM IAA…

Biopharma Compendium Accelerate Your CQA Efficiency and Approach it with Multi-Attribute Methodology Breakthroughs to Increase the Efficiency of Critical Quality Attribute (CQA) Testing and Allow for a Multi- Attribute Method (MAM) Production of therapeutic monoclonal antibodies (mAbs) relies on living…

HILIC Glycopeptide Mapping with a Wide-Pore Amide Stationary Phase Matthew A. Lauber and Stephan M. Koza Waters Corporation, Milford, MA, USA A P P L I C AT I O N B E N E F I T S ■■…