AUTHORS: Samantha Ippoliti, Jared Young, Katy McNally, Caitlin Hanna, Ying Qing Yu, Bradley Prater, Mark D. Wrona,
Waters™ Application Note
Streamlined mAb Subunit LCMS Workflow for Multiple Attribute Monitoring of Biosimilar mAb Candidates During Bioprocessing and Development
This application note summarizes a collaboration between Similis Bio and Waters Corporation™ to demonstrate the feasibility of an automated Protein A purification and LC-MS mAb subunit analysis of bioreactor samples to screen biosimilar monoclonal antibody (mAb) candidates in comparison to the innovator to support process development. The method was demonstrated to have sufficient sensitivity and precision to quantitatively assess N-linked oligosaccharides at levels known to impact pharmacokinetics and effector function activity, in addition to other post-translational modifications (PTMs) such as C-terminal lysine variants and other subunit-specific (LC & Fd’) modifications. Subunit mAb LC-MS monitoring methods such as this can be utilized to support mAb bioprocessing, development, and quality control within biopharmaceutical and biomanufacturing organizations.