Due to the nature of their production, biotherapeutics are difficult to manufacture. Growth conditions, purification protocols and formulation requirements can introduce unintended modifications into the protein structure that may affect its efficacy and safety. Imaged capillary isoelectric focusing  (iCIEF) provides a critical measure of quality throughout the development and manufacturing of biotherapeutics by offering rapid, robust and high-resolution charge variant analysis.

We are excited that our customers will soon be able to couple iCIEF charge variant separation directly with high-resolution mass spectrometry (MS) for rapid separation, quantification and identification of charge-based protein variants in a single iCIEF-MS assay.

What made this possible? The acquisition of Intabio, Inc., a privately held company that is developing the Blaze™ System for biotherapeutic analysis and quality assessment, on December 23, 2020 .

Intabio and SCIEX have been collaborating for over a year to couple the Blaze System with SCIEX high-resolution accurate mass (HRAM) systems to provide an integrated iCIEF-MS assay that can accelerate and transform biotherapeutic development and biomanufacturing.

The Blaze System enables the direct coupling of iCIEF charge variant analysis with high-resolution mass spectrometry to characterize intact proteins. This new system in development by SCIEX and Intabio features a small footprint to easily fit into the laboratory setting.

The Blaze System utilizes a proprietary microchip technology to integrate:

1. Charge variant separation by iCIEF 
2. Real-time, whole-column, 280 nm imaging of protein isoforms for detection and quantification
3. Delivery of each separated isoform by electrospray into an adjacent mass spectrometer to provide molecular identity

This seamless combination of technologies enables the rapid 1-step detection and unambiguous quantification and identification of charge variants of a biotherapeutic. The Blaze System accelerates biotherapeutic development by transforming a process that can take up to several weeks into one that takes just a few minutes.

Elimination of these serious bottlenecks of time and complexity allows users to characterize increasingly complex biomolecules faster. Coupling Blaze technology with SCIEX high-resolution MS systems enables more rapid sample throughput and helps users make more informed and timely decisions when they are needed. This results in the acceleration of critical decision-making and, in turn, the reduction of development timelines and cost, which is essential for successful drug development today.

The analytical capabilities that result from combining the Blaze System and SCIEX high-resolution MS systems can be applied throughout many stages of biotherapeutic development and bioproduction, including clone selection, process development, degradation studies and formulation. Early collaborative studies carried out with Merck and Janssen have demonstrated the power and benefits of iCIEF-MS.

The year 2021 is starting on a positive and exciting note. The new iCIEF-MS workflow from SCIEX and Intabio is just one of the many new solutions we are working on to facilitate more efficient and cost-effective development of novel, life-changing medicines. We look forward to working with existing and new customers on this rewarding journey.

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