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CE Chronicles Newsletter Vol 2 Issue 2

Volume 2, Issue 2, Winter 2026

Advancing the Analysis of Next Generation Biotherapeutics

In this era of next-generation biotherapeutics, novel and more effective biologics are growing in number, including antibody-drug conjugates (ADCs), bispecific antibodies, fusion proteins, and therapeutics utilizing viral vectors like LNPs and AAVs as delivery vehicles.

Access our eBook to learn about advancements in the analysis of these biotherapeutics using CE technologies. Learn how charge variant fractionation, when combined with downstream techniques such as high-resolution LC-MS and SPR, have accelerated workflows, improved sensitivity, and enabled deeper characterization of complex molecules.

 

Industry News

  • Teclistamab (TECVAYLI®) by J&J, a bispecific antibody, has shown promising results in the treatment of mutiple myeloma, capturing the attention of the FDA for accelerated approval. Read more.
  • Biopharma Dive has curated a list of the top 10 clinical trials to look out for in early 2026. Read more here.
  • The FDA approved the first ever gene therapy for the the treatment of Wiskott-Aldrich syndrome (WAS). Read more here.
  • Biogen forecasts growth in relation to key drugs launching in 2028. Read more here

Resources

Capillary Electrophoresis Instruments Maurice Systems Brochure

Brochure: Meet the Maurice Family

This brochure highlights the latest data and applications for your one-stop solution for automated icIEF and CE-SDS across all process stages. The MauriceFlex instrument features an icIEF-fractionation capability for further characterization of charge variants using LC-MS or SPR analysis.  Discover how to improve resolution, save time and reduce hazardous waste compared to IEX and SDS-PAGE methods.

ADC Maurice App Note thumbnail

App note: Unraveling Structural Complexities of ADCs

Read how the Maurice™ system enables robust characterization of antibody-drug conjugates (ADCs) through charge and size-based analysis. In addition, the unique on-board mixing (OBM) feature preserves pH-sensitive samples while the optional 458 nm filter can detect ADC payloads with native Fluorescence.

Viral Vector Characterization Application Note

App Note: Characterize Your Viral Vectors for Purity and Identity

Discover how CE-SDS can be utilized for the analysis of two AAV and LVV CQAs - identity and purity. Instead of using separate techniques and platforms (SDS-PAGE for AAV purity and confirming serotypes using PCR or ELISA), obtain this data on these two attributes with increased productivity and shorter timelines using a single platform. 

This application note presents an effective method for characterizing charge variants in a therapeutic bispecific antibody (BsAb) and a research-grade biosimilar.

App Note: Comparing Charge Variants with MauriceFlex and MS

Discover an efficient workflow for the characterization of charge variants fractionated on the MauriceFlex instrument, digested using the Genovis FabRICATOR® enzyme, and analyzed on the Waters BioAccord™ LC-MS using subunit mass analysis. 

icIEF Fractionation and SPR-Based workflow app note thumbnail

App Note: A Novel icIEF and SPR-Based Workflow

Read about a novel method that utilizes icIEF-based charge separation and fractionation followed by binding affinity analysis using surface plasmon resonance (SPR), offering a robust and efficient approach to compare differences in binding affinity between a bispecific drug and its research grade biosimilar. 

Rapid Analysis of Therapeutic Fusion Proteins App Note Mockup

App Note: Rapid & High-Quality Analysis of Therapeutic Fusion Protein

Explore how the Turbo CE-SDS method on the Maurice system provides a fast, reliable, and label-free approach for analyzing fusion proteins like Etanercept, with excellent linearity and reproducibility, facilitating high-throughput applications while ensuring data quality.

Be inspired by upcoming and on-demand webinars

Webinar Size and Purity Analysis of Complex Biologics

Webinar: Addressing the Challenges of Size and Purity Analysis for Fusion Proteins, ADCs and AAVs

Join our webinar on March 3 to discover the recent advancements in biotherapeutic size analysis and purity analysis using the Maurice CE‑SDS platform. Chia Thach (Bio‑Techne) will describe how the system improves workflows for characterizing Antibody‑Drug Conjugates (ADCs) and Adeno‑Associated Viruses (AAVs), highlighting how the Turbo CE‑SDS cartridge can significantly boost throughput and productivity. Caroline Daniels (Shattuck Labs) will demonstrate how her team uses the Maurice system to separate molecules based on differences in N‑linked glycosylation. After comparing the CE‑SDS Plus and Turbo cartridges for highly glycosylated heterodimeric fusion proteins, the Turbo CE-SDS cartridge was selected for routine use due to faster run times with maintained resolution. 

 

Considerations for Potency Assay Development and Analytical Characterization of mRNA-LNPs for Gene Editing Products

Join us at a BioPharma-hosted webinar on March 12 at 10:00 AM ET / 4:00 PM CET to hear from experts Benjamin Hall (Tessera Therapeutics) who will describe “Considerations for mRNA-LNP Potency Assay Development for Gene Editing Products” and Dr. Gargi Chaudhuri (Bio-Techne), who will discuss “Advancing the Analytical Characterization of mRNA-LNPs using imaged Capillary Electrophoresis,” and demonstrate how icIEF technology can be used to assess LNP identity and stability, in addition to assessing lipid composition variations, surface charge heterogeneity, and packaging efficiency.

 

mRNA-LNP Analysis With Maurice

Advancing Charge Variant Characterization of ADCs and mAbs using icIEF Fractionation and LC-MS

Nicki Zhang (formerly MilliporeSigma) and Nelly Luong (Technical University of Braunschweig) discuss  integrated workflows to characterize mAbs and ADCs with varying levels of heterogeneity. Nicki demonstrates how icIEF fractionation combined with MS enhances the resolution and interpretability of charge variant profiles to support formulation development, process optimization, and comparability studies. Nelly describes a preparative fractionation method that improves the sensitivity for subsequent peptide mapping using LC-MS.

Let's Meet Up

Join us at one of our upcoming User Meetings or Conferences to learn about the latest advancements in biotherapeutic characterization. Or let us provide lunch or snacks at your site while sharing our Biologics Bitesize Tech Talks on the topics of most interest to your lab.

Introducing: Biologics Bitesize Tech Talks

Do you want to learn about the latest applications for the Maurice and MauriceFlex platforms - but don't have much time? We’re happy to host lunch or a break at your convenience to discuss the topics of most interest to your lab. Choose from our menu of 15-minute bitesize talks to discover what’s new in the areas of biomolecular-specific analysis, icIEF fractionation, CE-SDS, Gene Therapy, and more!

Choose from a full menu of topics

Each attendee gets an insulated lunch bag, notebook, and pen

Product Updates

AAV

Explore recent publications to see the latest developments in CE Analysis using Maurice Platforms

(1) Determination of AAV Capsid Protein Ratios by Sodium Dodecyl Sulfate Capillary Electrophoresis (CE-SDS)—UV Absorption Method

Key Highlights:

  • CE-SDS with UV detection determines AAV capsid protein (VP1, VP2, VP3) ratios by separating denatured viral proteins based on size, typically showing a ~1:1:10 stoichiometry. 
  • Due to low capsid concentration in samples (ng/µL range), this method often requires specialized sample preparation to achieve necessary sensitivity. 
  • CE-SDS provides automated, rapid, and quantitative analysis, offering better precision than traditional SDS-PAGE

(2) Stability Under Different Stress Treatments of a Virus-like Particle Vaccine Based on a Recombinant Hepatitis E Vaccine

Key Highlights:

  • A recombinant VLP vaccine (Hecolin®) shows high stability under thermal (4-56°C), freeze-thaw, and mechanical stress, maintaining structural integrity and antigenicity.
  • Studies established that the 20-30 nm particles, based on the p239 capsid protein, resist significant denaturation in accelerated studies, with stable conformation confirmed by differential scanning calorimetry (DSC) and surface plasmon resonance (SPR). 

Technical Tips

Method Development and Optimization for ADC Analysis

In this episode from her series “Technical Tips from Monica Tyagi,” Dr. Tyagi discusses some simple but important steps for method development and optimization for the analysis of Antibody Drug Conjugates (ADCs), including utilizing the Maurice on-board mixing (OBM) feature and an optional 458 filter. She shares key resources highlighting icIEF + CE-SDS workflows. icIEF separates ADC isoforms based on isoelectric points, detecting charge variants that may arise from conjugation or degradation. CE-SDS separates ADC fragments based on size and can resolve light and heavy chains, aggregates, and fragments, providing purity profiles.

From Your Peers

Jana Stockel and David Richards, MilliporeSigma

"The primary advantage of MauriceFlex from the perspective of LC-MS analysis is the sample compatibility. The charge variants of interest are fractionated within an ammonium acetate matrix. This reduces the sample preparation time compared to other charge variant separation techniques such as ion exchange chromatography, where buffer exchange is often required due to the salt content present from the mobile phase."

- David Richards, PhD, Scientist, MilliporeSigma

FYP Jana Stocker & David Richards Headshots