Webinar | January 23, 2025

Linking mAb Product Quality Profile Changes To Your BioProcess: Case Study Of Dynamic Glucose Level Control In CHO Process Improves Product Quality

Source: 908 Devices

Changes made to the bioprocess can be linked to product quality attributes, but only if there are frequent data points to show the development throughout the bioprocess. Access to good product quality data at frequent timepoints from a full bioprocess can be a tall order for the analytical department.

In this webinar, Erin Redman, PhD, principal scientist at 908 Devices, guides us through an easy solution to acquire mAb quality attribute profiling (charge variant profile, sequence identity, and glycosylation profile). Presented here is a simple dilute-and-shoot analysis using ZipChip capillary electrophoresis separation coupled to a high-resolution mass spectrometer.

Then, Graziella Piras, PhD, senior director of strategic marketing, life science, describes a case study where a comparison of CHO fed-batch process runs with the usual daily bolus glucose feed strategy and a 2g/L dynamic glucose feed strategy, enabled by MAVEN monitoring and control, resulting in clear improvement in product quality profile.

Key takeaways:

  • Streamline mAb product quality assessment throughout a bioprocess run.
  • Charge variant profile, sequence identity and glycosylation profile, glycation.
  • Link process feeding strategy to product quality profile- Bioprocess monitoring enabling control.
  • Stabilize glucose level 2g/L by MAVEN control reducing glycation.
  • Enable off-line analytical and on-line process analytical technology (PAT) solutions.
  • Dilute-and-shoot ZipChip-MS CVA workflow enabling frequent measurements.
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