GEN-MKT-18-7897-A
Feb 26, 2021 | Biopharma, Blogs | 0 comments
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:
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.
RUO-MKT-19-12879-A
In biopharmaceutical development, sequence variants (SV) are considered an inherent risk of producing complex proteins in living systems. Sequence variants are unintended changes to the amino acid sequence of a biotherapeutic and can be caused by errors in transcription or translation in the host cell, or cell culture and process conditions. Detailed analysis of SVs is important in process and product development to ensure the drug’s safety and efficacy. Even low‑level sequence variants can have significant implications for product quality, safety, and efficacy, making their accurate detection and characterization a critical requirement across development, process optimization, and regulatory submission.
CE‑SDS remains a cornerstone assay for characterizing fragmentation, aggregation, and product‑related impurities in therapeutic proteins. UV detection has been the long‑standing standard. However, it frequently struggles with baseline noise, limited sensitivity for minor fragments, and subjective integration.
At SCIEX, innovation doesn’t stop at instruments; it extends to how you interact with your LC-MS/MS or CE systems every day. That’s why we’re excited to introduce the SCIEX Now spring 2026 improvements: a set of meaningful enhancements shaped directly by your feedback.
Posted by
You must be logged in to post a comment.
Share this post with your network