CASSS Sharing Science Solutions CE Pharm 2025

CE Pharm 2025 examines practical applications of capillary electrophoresis in biotechnology and pharmaceutical analysis. The September 7–10 symposium in Bethesda covered protein and nucleic-acid characterization, charge heterogeneity, CE-MS, capillary gel electrophoresis, and imaged isoelectric focusing. Its supplied topics also address mRNA integrity, antibody-drug conjugates, critical reagents, peak integration, validation, and troubleshooting. A separate fundamentals short course introduced CE principles and protein-therapeutic applications. The material is relevant to analytical scientists working in development, quality control, and regulatory support who want to connect instrument capabilities with day-to-day method challenges. The complete supplied topic sequence is retained below.

Learning Objectives

• Apply advanced charge heterogeneity profiling and mass spectrometry (CE-MS) methodologies for analyzing Antibody-Drug Conjugates (ADCs) and monoclonal antibodies.
• Optimize Capillary Gel Electrophoresis (CGE) and native fluorescence detection techniques to evaluate RNA, mRNA integrity, and protein quantification in conjugate vaccines.
• Navigate regulatory considerations, including leveraging prior knowledge in analytical method development, adhering to ICH Q2 R2 guidelines, and effectively communicating CE method issues to QA and management.
• Develop and validate high-performance separation techniques for complex biotherapeutics, including mRNA vaccines, plasmid topologies, and virus-like particles.
• Implement robust strategies for critical reagent management, peak integration challenges, and CE method troubleshooting within a biopharmaceutical setting.

Topics

• A Novel Derivatization-Based CGE Assay for Quantifying Free Proteins in Conjugate Vaccines

• Advanced Charge Heterogeneity Profiling of a Model ADC via icIEF Fractionation and Mass Spectrometry

• Advanced Electrophoresis Solutions Ltd – Partner Showcase

• Advancement of Capillary Gel Electrophoresis Through the Use of Native Fluorescence Detection

• Advances in Capillary Electrophoresis for Biotherapeutic Development Presented by Bio-techne

• Agilent Technologies Inc – Partner Showcase

• Becoming the CE Expert in Your Organization – Best Practices Exchange

• BioPhase 8800 System Advancing Capillary Electrophoresis With Native Fluorescence Detection

• Bio-Techne and Protein Simple – Partner Showcase

• Capillary Electrophoresis to Quantify Drug Inhibition of H1N1 and H5N1 Neuraminidases

• CASSS Welcome and Introductions

• CE Pharm 2025 Scientific Program and Summary Infographic

• CE-MS – Current Trends and Applications in Biopharmaceutical Development

• Charge Heterogeneity Analysis of Antibody Drug Conjugates Capillary Zone Electrophoresis

• Charge Isoform Identification using the MauriceFlex

• Closing Remarks and Invitation to CE Pharm 2026

• Communicating Issues with Capillary Electrophoresis Methods to Management, QA, and Regulatory

• Design of a Capillary Isoelectric Focusing Electrospray Ionization-Mass Spectrometry Interface for High Resolution Proteoform Analysis

• Development and Optimization of a CGE-LIF Method for RNA Integrity Characterization using SCIEX 9000 RNA Kit

• Empowering a Speak Up Culture in the Biopharmaceutical Industry – Promoting Psychological Safety

• Evaluating the Impact of Analytical Method Parameters on Therapeutic mRNA Integrity by Capillary Gel Electrophoresis

• Forgotten CE Technologies – CGE, ITP, Affinity CE, Taylor Dispersion

• High-Performance Native Separation of mAb Proteoforms by CZE-MS Under Native and Denaturing nanoESI Conditions

• How Fast Can We Go Without Sacrificing Quality

• ICH Q2 R2 and CE

• Improving ADC Sample Stability in icIEF by Altering Separation Matrix pH a Case Study

• Keynote I Microtechnologies for Acquiring Biological Information CE Pharm Award

• Label-Free Native Fluorescence for High-Sensitivity Protein Analysis Using a Multi-Capillary Electrophoresis System

• Leveraging Prior Knowledge in Analytical Method Development and Validation Regulatory Considerations for Protein Products

• Lunch and Learn Technical Seminar Presented by SCIEX

• Managing Critical Reagents for Capillary Electrophoresis Methods

• mRNA Vaccine CE Applications

• Partner Showcases: Advanced Electrophoresis Solutions Ltd., Bio-Techne, and SCIEX

• Plasmid Topology Analysis with the Agilent Fragment Analyzer System

• Reference Data for Peak Integration in Capillary Electrophoresis Another Successful CASSS Project

• SDS-CGE and CGE Method Development and Application

• Separation of Virus Like Particles and Nano-Emulsions for Vaccine Development by Capillary Zone Electrophoresis

• Session I – V Panel Discussions

• Session VI – Next Generation Investigators

• Session VII – CE-MS and Peak ID Product Characterization and Panel Discussion

• Strategies and Challenges with Peak Integration in CE

• Strategies and Qualification of Critical Reagents

• Technology Advancements in CE

• Troubleshooting Workshop

• Unraveling Biopharmaceutical Heterogeneity with Advanced Imaged Capillary Isoelectric Focusing Methodologies

• Utilizing Fluorescence Detection to Improve icIEF Analysis

Keynote Faculty

• J. Michael Ramsey – University of North Carolina, Chapel Hill: Microtechnologies for Acquiring Biological Information.
• Joel Welch – FDA, CDER: CE’ing Into the Future: The Role of Capillary Electrophoresis in Innovation for Biological Products.

J. Michael Ramsey received the 2025 CE Pharm Award.

Program scope: The original meeting included a September 7 fundamentals short course, scientific sessions, technical seminars, roundtables, and a troubleshooting workshop. These program entries do not confirm that every activity is included in the supplied files. Event attendance, livestream access, publisher accounts, and platform extras are not included.