icIEF-MS accelerates biotherapeutic development through identification of charge variants at the intact protein level

FRAMINGHAM, Mass. — SCIEX, a global leader in life science analytical technologies, builds a new category of analytical instrumentation with icIEF-MS. Built in collaboration with customer partnerships, this new technology is part of the journey to help scientists close the developability gap.

“Customers tell us that they are looking for orthogonal and higher throughput technologies to address analytical challenges,” said Mani Krishnan, Vice President and General Manager, Biopharma and CE, at SCIEX. “As we continue to develop icIEF-MS, the feedback is that it provides a unique and powerful analysis method that is simply not available today. In fact, the ability to monitor multiple product quality attributes in a single integrated assay can streamline and accelerate the biotherapeutic development process, allowing for meaningful decisions earlier and reduced risk of costly downstream failures.”

Earlier scientific presentations on icIEF-MS by biopharmaceutical thought leaders at CE Pharm and CASSS Mass Spec demonstrated key capabilities.

• “Characterization of mAbs with tunable glycosylation profiles produced in engineered mammalian cells (CHO) by a novel icIEF-MS platform,” showcased mass spectra of intact mAbs collected for each species contributing to the inherent icIEF profile within a 30-min analysis.
• “Rapid characterization of charge isoforms of new modalities by icIEF-MS,” demonstrated that icIEF-MS is exceptionally capable of identifying charge profiles of a novel bispecific antibody construct.
• “There were four in the bed: utilizing [icIEF-MS] to expedite identification of capillary isoelectric focusing peaks,” showed what took weeks to complete using chromatography enrichment took less than a day with icIEF-MS.

This year at ASMS, new findings will be presented: “Rapid characterization of charge variants by online cIEF/MS supporting biopharmaceutical process development in cell line selection and identifying lead molecules.” The presentation will highlight how icIEF-MS provides directly actionable information on cell line selection and the understanding of cell culture processes and variables on developing biotherapeutic candidates.

Mani Krishnan adds, “Biopharma scientists are faced with extremely time-consuming, indirect assays to measure molecular attributes, attributes that can impact product function. This new technology aims to reduce the time to a confident, actionable answer from weeks down to 1 hour. We will continue to work together with biopharma scientists to close the developability gap.”

Prioritizing customer partnerships and feedback is at the heart of SCIEX solution development. This is evident through recent launches of the ZenoTOF 7600 system, the Echo® MS system, the SCIEX 7500 system, SCIEX OS, Molecule Profiler and Biologics Explorer, aiming to help scientists better understand molecular liabilities and close developability gaps for next generation biologics and genomic medicines. The developing icIEF-MS technology will complement recently launched innovations for biopharmaceutical labs as SCIEX continues to collaborate with esteemed customers to advance the technology.

To learn more about icIEF-MS, visit here.

About SCIEX

SCIEX delivers solutions for the precision detection and quantification of molecules, empowering our customers to protect and advance the wellness and safety of all. We have led the field of mass spectrometry for 50 years. From the launch of the first ever commercially successful triple quadrupole in 1981, we have developed groundbreaking technologies and solutions that influence life-changing research and outcomes.

Today, we continue to pioneer robust solutions in mass spectrometry and capillary electrophoresis. Our customers are able to quickly respond to environmental hazards, better understand biomarkers relevant to disease, improve patient care in the clinic, bring relevant drugs to market faster and keep food healthier and safer.

That’s why thousands of life science experts around the world choose SCIEX to get the answers they can trust to better inform critical decisions that positively impact lives.

For more information, visit sciex.com.

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