June 16, 2020 – Newark, CA – Intabio, Inc., a developer of analytical solutions that provide profound efficiency gains across all stages of biopharmaceutical development and manufacturing, today announces commercial availability of the Blaze System. Blaze addresses a critical bottleneck for biopharmaceutical developers by identifying unwanted structural modifications in intact biotherapeutic proteins with blazing speed, enabling scientists to make faster, more informed decisions while maintaining the highest product quality.
“The need to shorten drug development timelines has never been clearer than today,” said Intabio's CEO and co-founder, Lena Wu, Ph.D. “We have collaborated with many of the world’s leading Biopharma development groups and mass spectrometry companies to directly address that need. With Blaze, crucial drug development decisions can be made months earlier.”
Intabio early access customer John Teare, Ph.D., VP and Cofounder of Coagulant Therapeutics Corp, added “The Blaze technology promises to provide extremely rapid and comprehensive protein characterization earlier in bioprocess development with less analytical development time and much less material. Blaze will enable shorter development times to get high quality biotherapeutics to the clinic faster.”
Intabio’s Blaze System couples two gold-standard analytical techniques - imaged capillary isoelectric focusing (iCIEF) and high-resolution mass spectrometry (MS) - into a single 15-minute assay with 100 times the throughput of traditional workflows. Microfluidic iCIEF separations of intact protein charge variants are performed by Blaze’s microchip-based cartridge, which uses 280-nm imaging for relative quantitation of charge variant peaks. Following iCIEF separation, each peak is introduced into an adjacent MS system for mass determination. Biotherapeutic developers can quickly monitor multiple Critical Quality Attributes (CQAs) directly on intact proteins – a powerful capability when faced with large numbers of samples and tight timelines. Key Blaze applications include cell line development, bioprocess optimization, and forced degradation studies.
Blaze systems feature a new version of Protein Metrics’ Byos® software suite customized for Blaze iCIEF-MS data analysis. The software was developed under the Intabio-Protein Metrics strategic partnership announced earlier this year. At present, Blaze systems can be interfaced with SCIEX TripleTOF 6600 and Thermo Fisher Q Exactive Plus high-resolution MS systems. Compatibility with additional MS systems is slated for release in 2021. The Blaze System is available for customer shipments in North America only beginning in late 2020.
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 gratefully acknowledges grant support by the National Center for Advancing Translational Science (NCATS) of the National Institutes of Health and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL).
Wally Ausserer, Ph.D.
Strategic Advisor, Intabio
M: +1 (916) 335-8002