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Webinar: Accelerate Your Biotherapeutic Development with a USP 129-Suitable Automated CE-SDS Platform

Webinar Summary

Part 1: Using an Automated CE-SDS Platform in Efficient Biosimilar Comparability Studies
Speaker: Dr. Richard L. Easton, Technical Director of Structural Analysis, BioPharmaSpec

The route to market for biosimilars places strong emphasis on characterization tools for establishing comparability between biosimilar and innovator products. Addressing analytical challenges in fast-forwarding biosimilar development processes requires implementing sophisticated analytical instruments with advanced technologies. The ICH Q6B, cited by both EMA and FDA, highlights electrophoretic data as an important part of the molecule’s full structural characterization. In the first part of the webinar, Dr. Richard L. Easton, Technical Director of Structural Analysis at BioPharmaSpec, will present data from studies with monoclonal antibodies, heavily glycosylated species, and PEGylated species showcasing how CE-SDS with Maurice can be used to provide reliable insights into the structure of different types of biopharmaceuticals, including assessments of size heterogeneity, presence of partial species in monoclonal antibody preparations, impurity analyses, and batch to batch comparability.

Part 2: Characterization of Maurice CE-SDS PLUS for USP <129> Suitability
Speaker: Chris Heger, Ph.D., Director, Applications Science, Bio-Techne

Capillary electrophoresis sodium dodecyl sulfate (CE-SDS) has become the gold standard technique for the quality-control of therapeutic mAbs and proteins due to its ease of implementation, robustness, and reproducibility, replacing the more traditional and labor-intensive technique such as SDS-PAGE gel. In the second part of the webinar, Dr. Chris Heger will discuss how they used the monoclonal IgG System Suitability Reference Standard developed by U.S. Pharmacopeia (USP) to assess the rigor and robustness of an optimized Maurice™ CE-SDS PLUS method compared to the recommended USP protocol provided in monograph <129>, and show how this optimized method demonstrated less fragmentation compared to the USP <129> method, was less susceptible to sample injection variations, and provided comparable data to the USP <129> monograph for mAbs.

What you’ll learn in this webinar:

  • Crucial insights into the structure of mAbs, heavily glycosylated species, and PEGylated species
  • Information on size heterogeneity, partial species in mAbs, and other impurities
  • Reproducible batch-to-batch comparisons
  • A USP <129> suitable CE-SDS method for comparable data, less fragmentation, and low injection-induced variations.