Date and Time
September 30 - October 2, 2025
Stay tuned for more talks and posters.
| Time | Type | Description | Room / Location | Presenter |
| N/A | POSTERS | Enhancing protein purity analysis using capillary electrophoresis-sodium dodecyl sulfate (CE-SDS) with native fluorescence detection (NFD) on the BioPhase 8800 system
The integration of NFD into the BioPhase 8800 system introduces a powerful, label-free detection mode that significantly enhances sensitivity, baseline stability, and repeatability across a range of capillary electrophoresis workflows. This presentation highlights the application of NFD in protein therapeutic and viral vector characterization, demonstrating clear advantages over traditional UV detection.
While the BioPhase 8800 system has established a strong track record for consistency and robustness using UV detection in CE-SDS analysis, users often encounter baseline fluctuations that complicate data processing. Additionally, current strategies to analyze low-concentration samples typically require labeling for laser induced fluorescence (LIF) detection, adding complexity and potential variability.
NFD addresses these challenges by delivering a stable baseline and improved sensitivity without the need for sample labeling. In reduced CE-SDS analysis of immunoglobulin G (IgG) controls, NFD provided excellent resolution between non-glycosylated heavy chain (NGHC) and heavy chain (HC) peaks, and good repeatability for migration time and HC/light chain (LC) ratio. In non-reduced CE-SDS, NFD detected lysozyme impurity spiked into the United States Pharmacopeia (USP) IgG system suitability standard down to 0.01%, demonstrating sensitive detection of impurities using NFD.
NFD also demonstrated strong performance in adeno-associated virus (AAV) capsid protein analysis. Comparative studies across two AAV serotypes using UV, LIF, and NFD showed that NFD enables label-free sample preparation, stable baselines, and repeatable quantitation of viral protein ratios. Superior linearity and assay precision further reinforce its value in AAV purity assessment.
Together, these findings establish NFD on the BioPhase 8800 system as a robust, sensitive, and efficient detection mode for protein and viral vector characterization in size-based CE-SDS workflows.
SCIEX | N/A | Dr Stephen Lock |
| N/A | POSTERS | Characterization workflows for CRISPR-Cas9 gene editing products, plasmids, and mRNA drugs on a single capillary electrophoresis (CE) platform
Gene editing is one of the fastest-growing areas in biotechnology and biopharmaceutical research, with CRISPR-Cas9 leading the field as the primary method. A common strategy involves co-delivering single-guide RNA (sgRNA) and Cas9 mRNA to improve genome editing efficiency. However, the significant difference in molecular size between sgRNA (~100 nt) and Cas9 mRNA (~4.5 kb) creates challenges for analytics supporting co-formulation and quality control. Additionally, developing mRNA-based vaccines and therapeutics requires careful evaluation of the quality of plasmid, linear dsDNA templates, and in vitro transcribed (IVT) mRNA. Detecting impurities in these three distinct molecular types is challenging, as each requires high-resolution separation.
This poster presents results in quality assessment of gene editing products and of mRNAs, starting from plasmids, on a single CE platform—the BioPhase 8800 system.
Analysis of the sgRNA and Cas9 mRNA individually using the RNA 9000 Purity & Integrity kit with capillary gel electrophoresis and UV detection (CGE-UV) indicated high purity for both samples. Simultaneous analysis of the sgRNA and the Cas9 mRNA at different ratios demonstrated an outstanding correlation between the theoretical and the measured ratio of the sgRNA to Cas9 mRNA, with an R2 value of 0.9997. Therefore, this workflow enables a reliable assessment of the ratios of sgRNA and Cas9 mRNA, a critical quality attribute (CQA) impacting the efficacy of the final co-delivered CRISPR-Cas9 product.
Automated, effortless plasmid purity assessment with the DNA 20 kb Plasmid and Linear kit and pre-assembled bare-fused silica (BFS) cartridge on the BioPhase 8800 system generated results with high resolution of plasmid isoforms and excellent repeatability using CGE-LIF (CGE with laser-induced fluorescence detection). Accurate, high-resolution sizing during the purity assessment of the linear dsDNA template demonstrated the capability of detecting near full-length impurity with truncations that may otherwise go unnoticed. High-resolution RNA analysis enabled the separation of mRNAs with different tail lengths and the detection of tailless impurities. Our results revealed that high plasmid purity alone was not enough to ensure the quality of the IVT mRNA. A thorough characterization of the linearized dsDNA template before IVT mRNA production is also necessary to ensure the quality of the final IVT mRNA product.
Overall, these assays demonstrate that the BioPhase 8800 system is a valuable tool for the analysis of gene editing products, plasmids, and mRNA vaccines and therapeutics.
SCIEX | N/A | Dr Stephen Lock |
| N/A | POSTERS | In-depth charge heterogeneity analysis of antibody-drug conjugates with a streamlined icIEF-UV/MS and EAD-based peptide mapping workflow
This poster demonstrates the unique capabilities of imaged capillary isoelectric focusing (icIEF)-UV/MS and electron activated dissociation (EAD)-based peptide mapping workflows for rapid charge heterogeneity analysis and comprehensive characterization of a GlyCLICK®-generated antibody-drug conjugate (ADC).1 These orthogonal, streamlined workflows provide multi-level information about product quality attributes (PQAs) of ADCs, facilitating important decision-making early in the development pipeline.
SCIEX | N/A | Dr Stephen Lock |
| N/A | POSTERS | Enhanced sensitivity of intact LC-MS approaches to expand the capability of biotherapeutic analysis with a novel QTOF
Sensitive detection and accurate mass measurement of intact proteoforms or impurities are essential for the comprehensive analysis of new-generation biotherapeutics with increasing complexity to ensure product quality and safety. This poster describes an enhanced intact mass spectrometry (MS) workflow with increased sensitivity for accurate mass measurement of biotherapeutics and their proteoforms. The advancements in the ion source, optics and detectors of a novel QTOF system led to superior detection of intact biotherapeutics and impurities with reduced sample consumption compared to the older platform.
SCIEX | N/A | Riccardo Rubbiani |
