INNOVATOR AND BIOSIMILAR INFLIXIMAB: COMPARABILITY ASSESSMENT OF THE HOST CELL PROTEINS AND PROTEIN HIGHER ORDER STRUCTURE

IDENTIFICATION AND QUANTIFICATION OF HOST CELL PROTEIN IMPURITIES IN HIGH PURITY MONOCLONAL ANTIBODIES DOWN TO 1 PPM: AN INTER-LABORATORY STUDY Catalin Doneanu1, Scott J. Berger1, Malcolm Anderson2, Brad Williams3, Matt Lauber1, Asish Chakraborty1 and Weibin Chen1 1 Waters Corporation, Milford,…

Identifying Monoclonal Antibody Mutation Sites Using the Agilent 1290 Infinity II 2D-LC Solution with Q-TOF LC/MS Application Note Biopharmaceuticals and Biosimilars Authors Abstract Koen Sandra, Gerd Vanhoenacker, In recent years, 2D-LC has been highly promising for the detailed characterization Mieke…

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…

APPLICATION NOTE 65888 Structural characterization of the therapeutic antibody and biosimilar product with hydrogen deuterium exchange mass spectrometry Authors: Terry Zhang and Rosa Viner Thermo Fisher Scientific, San Jose, CA, USA Keywords: Peptide mapping, protein conformation, bottom-up, trastuzumab, biosimilar, deuterium…