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Developing a biosimilar drug requires screening many samples originating from different cell lines to select the most appropriate ones for further process development. Each sample needs to be characterized by their critical quality attributes, such as glycosylation or charge variants, which can be used to identify potentially harmful modifications in the samples. Common techniques used to determine the charge variants of a sample, such as ion exchange chromatography, are time- and material-consuming and typically use optical detection to determine the relative peak area of acidic and basic variants.

Microfluidic capillary electrophoresis coupled to mass spectrometry (CE-MS) is an alternative approach for assessing charge heterogeneity. The microfluidic CE technology boasts low sample consumption and short analysis times, while the hyphenation to MS enables identification of the charge variants and the glycosylation profile of the native protein.

In this GEN webinar, our expert speakers, Erin Redman, PhD, and Ruben Cageling, will describe how the ZipChip microfluidic CE-MS technology enables rapid early-stage clone screening for biotherapeutics development. They will present a case study where the ZipChip was used to select clonal cell lines based on their charge variants and glycosylation profile. Furthermore, they will also highlight the new CVA kit, which enabled better separation and sensitivity in charge variant analysis of biotherapeutics. Key learning objectives from this webinar will be:

  • Microfluidic CE-MS technology basics and applications 
  • The benefits of combining charge variant separations with mass spec characterization 
  • How this technology is an asset for rapid clone screening of biosimilar candidates in the biopharmaceutical industry

A live Q&A session followED the presentation, offering a chance to pose questions to our expert panelists.

Erin Redman
Erin Redman, PhD
Principal Scientist
908 Devices
Ruben Cageling
Ruben Cageling
PhD Candidate
Polpharma Biologics Utrecht BV and VU Amsterdam