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Intabio Announces Seminal Publication Describing Blaze™ Technology for Comprehensive Biopharmaceutical Product Quality Analysis

January 7, 2020 GMT
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The December 2019 cover picture of the journal Electrophoresis shows Intabio’s integrated iCIEF-MS assay that enables direct coupling of an imaged capillary isoelectric focusing (iCIEF) microchip to a high‐resolution MS detector for characterization of intact biotherapeutic protein charge variants.
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The December 2019 cover picture of the journal Electrophoresis shows Intabio’s integrated iCIEF-MS assay that enables direct coupling of an imaged capillary isoelectric focusing (iCIEF) microchip to a high‐resolution MS detector for characterization of intact biotherapeutic protein charge variants.

NEWARK, Calif., Jan. 7, 2020 /PRNewswire/ -- Intabio, Inc., a Silicon Valley-based company developing analytical solutions to transform biotherapeutic development and biomanufacturing, today announced a publication in Electrophoresis that provides the first in-depth description of Intabio’s Blaze imaged capillary isoelectric focusing – mass spectrometry (iCIEF-MS) system and its ability to quickly characterize and identify intact protein charge variants. Using a trastuzumab monoclonal antibody (mAb) as a test molecule, the Blaze iCIEF-MS system quantified charge variants and identified 33 distinct molecular variants in a single 15-minute assay, which represents a dramatic leap in Biopharma’s ability to monitor a wide range of mAb critical quality attributes in real-time. The Blaze system is designed to interface with high resolution MS systems from several vendors. Beta testing is slated for the second quarter of 2020, with commercial shipments planned for late 2020.

“By integrating multiple laboratory operations onto a microchip, the Intabio team has developed a powerful new technique for detecting and identifying biotherapeutic structural variants,” said Erik Gentalen, Intabio’s CTO and co-founder. “The Blaze system will significantly expand Biopharma’s ability to monitor multiple product quality attributes and degradation in the intact protein, ultimately accelerating development and reducing the risk of bioproduction failures.”

Intabio’s Blaze is a bench-top instrument and consumable that performs a comprehensive analysis of antibody and protein biopharmaceutical product quality with 100-fold higher throughput than traditional approaches. Blaze assays use microchip functionality to integrate (1) separation of protein isoforms by isoelectric focusing, (2) 280-nm imaging for protein isoforms quantitation, and (3) electrospray ionization for delivery of the separated isoforms to an adjacent MS for peak identification. The speed of the Blaze system enables detailed characterization of antibody drug candidates throughout the drug development process, from clone selection to commercial production. Commercial release of the Blaze system is targeted for the second half of 2020.

Reference: Mack, S., et al. A novel microchip-based imaged CIEF-MS system for comprehensive characterization and identification of biopharmaceutical charge variants. Electrophoresis, 40: 3084-3091 (2019).
https://onlinelibrary.wiley.com/doi/pdf/10.1002/elps.201900325

About Intabio

Intabio, Inc. is a Silicon Valley-based company developing analytical solutions to transform biotherapeutic development and manufacturing with products that provide early product quality characterization and profound efficiency gains across all stages of biopharmaceutical development and manufacturing. Intabio’s first product, the Blaze system, is a microchip-based instrument system that will provide rapid detection and identification of subtle protein modifications - modifications that can undermine the stability and efficacy of biotherapeutic drugs such as monoclonal antibodies and recombinant proteins. For more information, please visit us at www.intabio.com or email info@intabio.com.

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SOURCE Intabio, Inc.