Critical Quality Attribute Monitoring of mAbs at the Intact and Subunit Levels Using a Cost-Effective, Simple and Robust LC/MS Solution

Agilent-NISTmAb Intact & Subunit Analysis Using Reversed Phase Agilent BioHPLC Columns Application Compendium Contents Agilent-NISTmAb Standard (P/N 5191-5744; 5191-5745) was aliquoted from NISTmAb RM 8671 batch. Quality control (QC) testing is performed using Agilent LC-MS system. QC batch release test…

Agilent BioHPLC Columns Characterization of NIST Monoclonal Antibody Critical Quality Attributes Application Compendium Contents Agilent-NISTmAb Standard (P/N 5191-5744; 5191-5745) was aliquoted from NISTmAb RM 8671 batch. Quality control (QC) testing is performed using Agilent LC-MS system. QC batch release test…

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…

An Integrated Workflow for Intact and Subunits of Monoclonal Antibody Accurate Mass Measurements Application Note Biotherapeutics and Biosimilars Authors Introduction Shuai Wu and Maryann Shen Monoclonal antibody (mAb) based entities represent a rapidly growing class of biologics that require extensive…