Automated LC-MS Workflow for CQA Assessment of Protein Therapeutics with Speed and Simplicity for Process Development
Analytical testing in process development for protein therapeutics is demanding for several reasons: large number of samples, tedious and labor-intensive sample prep, and relative long analysis time for LC-MS.
Bioreactor samples also require careful preparation to enable high quality and sensitive profiling of critical quality attributes (CQAs), especially for low level post translational modifications (PTMs).
In this webinar, we present automated workflows that encompass simplified sample prep (Protein A purification, and/or mAb subunit digestion) to rapid LC-MS analysis through data processing. We share application examples of LC-MS subunit analysis using the Genovis FabRICATOR® (IdeS) enzyme to compare CQAs of biosimilars and innovator mAbs:
Automated mAbs CQA assessment of cell culture samples - intact mass analysis and subunit analysis (presented by Andreas Nageli, Genovis)
**Automated mAbs CQA assessment comparing Biosimilars vs Innovator - Subunit analysis for glycan profile and for modification of unpaired cystines (CQA) with samples from clone selection and from downstream processing (a Similis Bio-Waters Collaboration)
You will learn from this webinar how to make your analytics higher throughput, with less human intervention, all while providing high quality, sensitive and specific characterization data, ultimately leading to better, faster decision making.**
Secure your spot to see the reveal of the latest version of the Waters Bioprocessing Walk-up Solutions. Be the first to learn how Waters is enabling bioprocess teams to acquire high quality LC-MS analytics through better automation at the point of need.
Presenter: Samantha Ippoliti (Principal Scientist, Discovery & Development- Biopharma, Waters Corporation)
Samantha (Sam) joined Waters (Milford, MA) in 2018 and has worked on a variety of applications for LC-MS based biopharmaceutical characterization, including peptide mapping analysis and method development, and intact/subunit analysis via reversed phase (RP) and ion exchange (IEX) -MS. Sam has experience with analysis using BioAccord, Xevo series, Synapt XS, and Cyclic IMS LC-MS instruments. Prior to joining Waters, she was part of the LC-MS characterization group supporting a biopharmaceutical developability assessment group at Novartis in Cambridge, MA. (Sam acquired a BS-MS in Chemistry from Northeastern University in 2012.)
Presenter: Andreas Nageli, PhD (Principal Scientist, Genovis)
Andreas joined Genovis in 2018. As Principal Scientist he is involved in the development of new SmartEnzyme products and applications as well as supporting customers in introducing Genovis SmartEnzymes into their assays. Andreas also heads business development at Genovis. He holds a PhD in microbiology from ETH in Zurich, Switzerland.
