SCIENTISTS AT THE WCBP CONFERENCE HIGHLIGHT ADVANCEMENTS IN PROTEIN BIOTHERAPEUTIC CHARGE HETEROGENEITY CHARACTERIZATION USING THE MauriceFlex™ SYSTEM
- MauriceFlex™ system addresses limitations in charge variant characterization and protein size analysis
- Efficiency demonstrated in AAV gene therapy development and collecting charge variants of complex proteins
- None.
Traditionally, the characterization of charge species in biotherapeutics has faced significant challenges owing to the limitations in analytical tools, resulting in the use of time-consuming and laborious methods for isolating individual variants. Consequently, charge variant characterization has been a pain point in biotherapeutic process development. Traditional methods like ion-exchange chromatography (IEX), often encounter bottlenecks in method optimization, particularly when dealing with complex molecules like enzymes, fusion proteins, and antibody-drug conjugates (ADCs). MauriceFlex™, with the added capability of protein charge fractionation, offers a tool that reduces several pain points in charge species characterization, making it a routine assay that can be performed at multiple stages of process development.
During the WCBP conference, a presentation given by Xiaoping He and Sisi Huang from Pfizer, demonstrated how MauriceFlex™ enabled the characterization of charge species in AAV capsid proteins, helping the acceleration of AAV gene therapy development. The second presentation, by Qurrat (Anny) Ul-Ain and Zishuo (Toby) Cheng from Sanofi further showcased the MauriceFlex system's efficiency in collecting multiple charge variants of a complex protein with single-peak resolution for downstream mass spectrometry characterization.
"The discussions at the conference, particularly regarding the MauriceFlex™ system, reflect significant progress in the advancements of analytical techniques used in biotherapeutic development," said Will Geist, President of Bio-Techne's Protein Sciences Segment. "These developments underscore the need for continuous innovation around analytical methods, empowering scientists to obtain critical information they need to produce the best-in-class therapeutics for patients worldwide".
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