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Direct Microchip CE/MS Peptide Mapping Workflow for the Analysis of mAb CQAs

Microchip CE-MS technology, its capabilities, and typical application space.

Peptide mapping is considered the gold standard for the analysis of biopharmaceuticals. Classical analysis is performed through long workflows involving extensive sample handling and long liquid chromatography (LC-MS) analysis times.

The distinct advantages of short analysis times and unique separation mechanisms makes Capillary Electrophoresis (CE-MS) an attractive alternative for the peptide mapping analysis. Nevertheless, most existing sample preparation protocols are either incompatible with CE-MS analysis or require additional steps for salt removal that may increase sample handling.

  • An overview of the ZipChip Microchip CE-MS technology and its typical application space
  • How to optimize CE-MS compatible sample preparation using a total workflow length of 2 hours
    • Data analysis will provide full sequence coverage and accurate quantitation of product quality attributes
    • Wide applicability of the workflow to different IgG subclasses will be demonstrated
  • A panel discussion (Q&A) at the end
  • Microchip CE-MS technology, its capabilities, and typical application space
  • How CE-MS technology can enhance peptide mapping throughput
  • Coupling peptide mapping sample preparation of monoclonal antibodies to CE-MS analysis
  • CE-MS analysis provides robust determination of quality attributes in less than 15 minutes

Dr. Sara Carillo completed her Ph.D. in Chemical Sciences in 2013 at the University of Naples “Federico II”. Under the guidance of Prof. Corsaro, she focused on the structural characterisation of polysaccharides and glyco-conjugates from Gram-negative bacteria via NMR and mass spectrometry techniques, focusing on the immunological properties and potentials of extremophiles endotoxins. After a period at the University College of Dublin, in 2015 she joined Dr. Jonathan Bones’s research group in NIBRT working on understanding of the effects of extractables and leachables from single-use bioreactors on CHO cells N-glycome and produced monoclonal antibodies. She is now working in NIBRT as Bioanalytical Research Lead and is mainly interested in the development of new analytical approaches to ensure a deeper and easier understanding of biomanufacturing processes and biopharmaceuticals’ structural complexity.

Adi Kulkarni is a Principal Scientist. Adi has extensive experience in applying CE-MS in biopharma characterization workflows using different mass spec platforms. He has developed novel applications based on the ZipChip technology and managing strategic collaborations and partnerships. Prior to working at 908 Devices, Adi was an applications scientist at Bruker Daltonics where he worked on Bruker’s Q-TOF line of products. He received his Ph.D. at the University of Massachusetts in 2011 where he developed novel methodologies for the synthesis of nitrogen-containing heterocycles. After his Ph.D., Adi was a postdoctoral fellow at University of Southern California’s Loker Hydrocarbon Research Institute where he discovered new reagents for applications in organofluorine chemistry. He has authored 18 peer-reviewed articles.

Jonathan Bones is the principal investigator of the Characterisation and Comparability Laboratory at NIBRT. An analytical chemist by training, Jonathan’s research group specializes in the development and application of analytical solutions for problems associated with the manufacture and characterization of biopharmaceuticals. This includes recombinant proteins, monoclonal antibodies, and advanced therapies like AAV based gene therapy, cell therapy, and mRNA using their core excellence in analytical separations coupled to mass spectrometry.

Erin Redman is a Principal Scientist in the Research and Development division of 908 Devices. She joined the company in 2016 and has worked to develop protein characterization assays using the ZipChip technology and further the innovation microfluidic CE separations coupled to mass spectrometry. Prior to starting her career at 908 Devices, she received her Ph.D. under the direction of Professor J. Michael Ramsey at the University of North Carolina at Chapel Hill. There she developed microfluidic technology for interfacing high resolution separations with electrospray mass spectrometry for the characterization of intact biotherapeutic proteins and proteins from biofluids.

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