SCIEX Targets New Category of Analytical Instrumentation

SCIEX 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, CE & Biopharma, 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 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.