The traditional two-step workflow – iCIEF followed by MS – has been cumbersome and low capacity, creating a bottleneck in protein analytics that can lead to costly development delays and bioproduction failures.
Intabio developed the Blaze Microchip iCIEF-MS System to address the critical bottleneck in protein analysis.
Develop an in-line application for Blaze instrumentation using detection of protein structural variants by charge heterogeneity analysis with in-line mass spectrometer analysis of enable product quality assessment during bioproduction.
By implementing the Blaze™ Microchip System for real-time characterization of intact biopharmaceuticals, an organization can reduce analytical workflow bottlenecks and associated development delays by at minimum several months, enabling faster drug development and earlier market entry, which lowers overall biomanufacturing costs and accelerates patient access to critical therapies.
Develop Blaze methods for six mAb drug samples.
Demonstrate reproducibility and comparability with legacy partner data.
Present data to partners and query partners on MS integration needs.
Design and test additional MS adaptors.
Hold workshop with partners to assess requirements for Blaze in-line bioreactor analytics.
ElNaggar, M.; Herring, C.; Mack, S.; Ostrowski, M.A.; Gentalen, E. Coupling a microfluidic chip-based imaged capillary isoelectric focusing electrospray source to multiple mass spectrometry platforms for intact antibody characterization. ASMS 2020, Houston TX, June 2020.
Gentalen, E.; Lacy, S.; Richter, C.; Dolnik, V.; Ji, J.; Danan, L.; Mack, S. Multilevel characterization and identification of Infliximab posttranslational modifications by imaged cIEF-MS. ASMS 2019, Atlanta GA, June 2019.
Mack, S.; Bogdan, G.; Danan, L.; Dolnik, V.; Ducusin, M.; Ji, J.; Gwerder, E.; Herring, C.; Lacy, S.; Richter, S.; Walton, I.; Gentalen, E. A novel automated imaged cIEF-MS assay for rapid product quality characterization of intact biotherapeutic charge variants. CE Pharm 2019,Bethesda MD, October 2019.
Mack, S.; Lacy, S.; Richter, C.; Dolnik, V.; Ji, J.; Danan, L.; Trementin, G.; Gentalen, E. Microchip integration of imaged cIEF with mass spectrometry accelerates theidentification of charge variants in intact monoclonal antibodies. ASMS 2019, Atlanta GA, June 2019.
Blaze™ Microchip System for Real-Time Characterization of Intact Biopharmaceutical (PC2.1-084), NIIMBL Member Forum, Virtual, May 28, 2020.
Donnelly, D.; Patel, B.; Richardson, D.; ElNaggar, M.; Herring, C.; Mack, S.; Gentalen, E. Rapid characterization of therapeutic antibody charge variants using microchip-based imaged cIEF integrated with high resolution mass spectrometry. ASMS 2020, Houston TX, June 2020.
Patel, B., Rapid Characterization of Therapeutic Antibody Charge Variants Using Microchip-Based Imaged cIEF Integrated with High Resolution Mass Spectrometry, ASMS, Virtual, May 31, 2020.
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Intabio
Bristol-Myers Squibb
EMD Millipore Corporation
Genentech, Inc.
Merck Sharp & Dohme LLC
