Blaze™ Microchip System for Real-Time Characterization of Intact Biotherapeutics

The Blaze™ System accelerates biotherapeutic development by directly coupling imaged cIEF charge variant analysis with high-resolution MS detection for intact proteins. Blaze enables the identification of post-translational modifications that can undermine the safety and efficacy of biotherapeutic drugs. Even better, Blaze does it all in 15 minutes per sample, not days or weeks. With Blaze, scientists can make better, more informed decisions sooner while maintaining high product quality AND speed in their development programs.

 

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Monitor multiple CQAs in every sample

Determine multiple CQAs in every sample, even in the face of development timeline pressures. The Blaze instrument and microchip perform the iCIEF separation, UV quantitation, and electrospray ionization (ESI) for  mass spectrometry analysis, all in minutes and not days.  Obtain imaged cIEF high-resolution separations with profiles comparable to your existing technology. Measure pI and quantify relative peak areas for acidic, main, and basic charge variants by UV absorbance. Identify structural changes for each charge variant peak by high-resolution mass spec analysis.

iCIEF separation, UV quantitation and easy method transfer

The Blaze microchip iCIEF performance is comparable to other iCIEF systems.  Even better, Blaze couples to a mass spectrometer enabling further peak ID.  Using a 5-cm separation channel, Blaze provides high resolution iCIEF separations and uses 280nm whole channel imaging to monitor the iCIEF separation in real time, automatically reporting relative peak areas for major charge variants. Blaze uses the common carrier ampholytes such as Pharmalytes® and SERVALYT™, so transfer of legacy methods to the Blaze System will be straightforward.

Peak ID with MS characterization in minutes

Identification of unknown iCIEF peaks may requires multiple weeks, involving process scale-up, HPLC method development, fraction collection, and MS analysis of the collected fractions. These traditional charge variant characterization workflows create a huge bottleneck in biologic development that can lead to difficult choices between determining CQAs or meeting development timeline pressure. 

 

The Blaze System’s expedient workflow integrates imaged cIEF separation and MS peak analysis into a seamless, 15-minute process. Plus, the integrated autosampler provides unattended overnight analysis for up to 25 samples.

Powerful data, simple software

 

Trailblazer software provides seamless operation of Blaze for iCIEF-MS data acquisition and iCIEF data analysis. Batch mode enables users to run a set of samples for efficient walk-away operation. Trailblazer provides the necessary information for combined iCIEF and MS data analysis and reporting using mass-spectrometer, vendor-neutral Protein Metrics data analysis software. Novel data visualization capability allows users to quickly view three-dimensional data that includes focusing and mobilization of the entire run, to assist with method development and troubleshooting. Not only is the CIEF column imaged in real-time with Trailblazer, but the electrospray is also visualized to ensure optimal MS results.

 

Easily deconvolute glycosylation isoforms, terminal lysine variants, amino acid oxidations, and other PTMs in just minutes with Byos for Blaze from Protein Metrics. This allows researchers to move from raw data files to report in just minutes, with the click of a mouse. Designed to support users with a range of expertise Protein Metrics software is installed in over 100 biopharmaceutical companies worldwide.

Compatible with a growing number of MS systems

The Blaze System is compatible with the Thermo Fisher Q Exactive and SCIEX 6600. Intabio scientists are working hard to expand our list of compatible MS Systems.  Keep on the lookout for additional MS system compatibility in the coming months.  See our poster video "Coupling a Microchip-Based Imaged cIEF Separation via ESI to Multiple Mass Spectrometry Platforms for Intact Antibody Characterization" to learn more.  

 

Resources Section

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The Blaze system is the first commercially available instrument to enable iCIEF to MS integration in a seamless assay.  Below we provide a comprehensive overview of the Blaze technology through an assortment of videos, webinars and technical literature.  

      The above-identified products, and/or the use of the above-identified products in a method may be covered by one or more U.S. and/or foreign patents, found at intabio.com/patents 

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