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CE Chronicles Issue 3 Biotherapeutic Characterization

Volume 1, Issue 3, Spring 2025

Beyond Gels: A Look at the Evolution of SDS-Based Protein Separation

Discover how CE-SDS is reshaping protein analysis in biopharma. This blog traces the journey from messy gels to automated, high-resolution separations with the Maurice™ system—bringing speed, reproducibility, and sustainability to the forefront of therapeutic development

Industry News

  • A combination of Enhertu and Pertuzumab sees soaring success in clinical trials for HER2-positive breast cancer. Read more.
  • Curious about the future of ADCs? Get some answers in this trendline.
  • The most exciting 2025 clinical trials to look forward to according to industry experts. Read more.
  • Planning out your business travel for 2025? Here is a list of the top biopharma conferences to look out for next year.

CE-SDS Resources

Application note on the advantages of CE-SDS over SDS-Page

Turbo CE-SDS Cartridges versus SDS-PAGE

CE-SDS delivers the same size-based protein separation as SDS-PAGE—without the manual mess. In this application note, see how the Maurice system with Turbo CE-SDS cartridge brings speed, precision, and reproducibility to protein characterization. Real-world comparisons with SDS-PAGE highlight why CE-SDS is the better fit for today’s analytical needs.

Viral Vector Characterization Application Note

AAV Purity and Identity Assay

This application note details capillary electrophoresis-sodium dodecyl sulfate (CE-SDS) analysis for two AAV CQAs - identity and purity. Instead of using SDS-PAGE for AAV purity and confirming serotypes using PCR or ELISA, you can get data on different attributes of your samples with one platform. 

Achieve USP <129> Compliance and Fast, Reliable Protein Analysis with Maurice CE-SDS

Equivalency Data for USP <129> using CE-SDS

This application note provides a comparability study using the Maurice CE-SDS PLUS method with the USP <129> protocol for the analysis of monoclonal antibodies. Using USP’s IgG System Suitability Reference Standard, the USP <129> method was first run on Maurice to determine ease of method transfer, followed by optimization of the Maurice protocol for comparison with USP <129>.

Thumbnail: Turbo Immunoglobulin M antibody analysis

Rapid analysis of IgM molecules

This application note demonstrates a rapid, high-quality CE-SDS method on the Maurice system for the analysis of IgM proteins. Specifically, you will read about how the Turbo CE-SDS cartridge provides data on IgM purity, stability, identity, and reproducibility, in just 14 minutes of run time. 

App Note Thumbnail - Turbo Bioprocessing Whitepaper

Assessment of Upstream Bioprocess Samples

This whitepaper describes how the Maurice instrument, using the Turbo CE-SDS cartridge, provides quantitative data that can be used for the analysis of purity of cell culture samples for both the supernatants as well as the purified antibodies. This workflow offers a fast method to screen a high volume of upstream samples during the cell culture and cell line development stages.

Lentivirus - viral vector characterization App Note Thumbnail

Simplified Lentiviral Vector Characterization

This application note demonstrates a robust and automated CE-SDS method on the Maurice instrument, which can be used as both an identity assay as well as a titer assay for LVV analysis using the Maurice CE-SDS PLUS method. The advantages versus using ELISA and SDS-PAGE methods are discussed.

Turn the Page on SDS-PAGE

Prof. Hermann Wätzig from the Institute of Medicinal and Pharmaceutical Chemistry, Braunschweig, Germany discusses how transitioning from SDS-PAGE to CE-SDS benefits research, both from an academic and industrial perspective. He highlights the current state-of-the art instrumentation and method development landscape. Dr. Chris Heger (Bio-Techne) highlights why the CE-SDS method is quickly replacing SDS-PAGE with its superior separation power, accurate quantitation, and ability for automation. In addition to the obvious advantages in time and labor, CE-SDS also stands out as a ‘greener’ method over SDS-PAGE.

Utilizing CE-SDS and icIEF methods for rAAV Characterization

Dr. Ana Carreras González (Viralgen) describes the utilization of CE-SDS and icIEF analytical techniques using the Maurice instrument to assess rAAV purity, identify process-related impurities and to study batch stability to characterize gene therapy product quality to help meet GMP standards and perform successful validations. Dr. Chris Heger (Bio-Techne) highlights the latest application using MauriceFlex icIEF-fractionation for capsid PTM analysis using LC-MS.

Unlocking the power of AAV & LVV Analytics for Optimizing Viral Vector Purity Analysis

Dr. Chris Heger (Bio-Techne) provides expert insights and strategies to help to easily optimize viral vector analysis on the Maurice platform, including optimized sample preparation and CE-SDS run conditions with specific examples of these methods being applied for viral vector purity, identity, and capsid protein ratio for AAV, LVV, and Adenovirus. Two CE-SDS cartridges (PLUS and Turbo CE-SDS) can support the entire development process, and their comparability and method differences are discussed.

Let's Meet Up

Come and chat with us at one of our upcoming User Meetings or Conferences to learn about the latest advancements in biotherapeutic characterization using CE:

Product Updates

Product Literature

Upcoming Virtual Workshops on Bio-Techne Academy

  • Comparison of Maurice Cartridges- May 15
  • MauriceFlex Fractionation and Method Development - June 5

 

Maurice family elements

Technical Tips

Optimizing CE-SDS Analysis Using Maurice

In her training series “Technical Tips from Monica Tyagi,” Dr. Tyagi discusses some simple but important steps from sample preparation to method optimization for different biomolecules that can have a big impact on the quality of your CE-SDS results. 

Some additional resources that Monica will share during this short training session include:

From Your Peers

Read our spotlight article on Dr. Professor Hermann Wätzig, Technical University of Braunschweig in Germany as he describes the advantages of using CE-SDS on the Maurice instrument compared to traditional SDS-PAGE for biotherapeutic protein size characterization.

"I think that the data we produced [on Maurice] shows excellent quality, due to the precise and reliable Maurice instrument."