CE Pharm 2024

Session Chair: Kristin Schultz-Kuszak, AstraZeneca

Affinity interactions can be probed or utilized by separation techniques. The properties of CE such has high efficiency, fast separation, and small sample requirements enable new ways to study and use affinity in separations analysis. A classic example is western blotting. Western blotting is one of the most widely used protein assays and the lack of a miniaturized counterpart has likely held back the use of CE in routine biochemistry. We have interfaced chip separations to blotting membranes for rapid westerns. Potential for multi-protein analysis is greatly enhanced by this method. The high speed of electrophoresis allows intact non-covalent complexes to be separated and detected. This capability has been extensively used for immunoassay and aptamer assay. The former has been used to monitor living tissue samples. Protein-protein complexes involved in intracellular signaling can be analyzed to generate quantitative information on binding and selectivity. We have also demonstrated fast (< 1 s) separations of substrates and products from enzymes allowing rapid enzyme assays. The high speed of the assays suggests they could be used in HTS for drug discovery. To achieve this, we have developed a system that allows discrete samples to be rapidly loaded in sequence onto a chip for injection and separation. Using this method over 1000 injections have been achieved in 17 min. Preliminary results suggest the method is stable enough for HTS opening the door to robust HTS of protein-protein interactions and enzyme activity. While this talk will focuse on reviewing these uses of CE, new directions in using fast LC for protein analysis will also be described.

Keynote Speaker:

Robert Kennedy, University of Michigan

Session Chairs: Mark Lies, Advanced Electrophoresis Solutions Ltd. and David Michels, Genentech, a Member of the Roche Group 

Session Speakers:

MS Online Coupling for Charge Heterogeneity Analysis of a Highly Glycosylated Recombinant Protein Vaccine

Xiaoxi Zhang, Thermo Fisher Scientific Inc.

Dual Hydrodynamic and Electrokinetic Actuation in a Capillary Assembly Enables DNA in Line Concentration and Separation

Frederic Ginot, Adelis Tech 

Session Speakers:

Application of CGE for Purity Analysis in Cell and Gene Therapy

Ryan Hylands, Pharmaron

Utilizing High-Throughput Capillary Electrophoresis for Bioprocess Development Support 

Brian Wei, Sanofi

Session Chairs: Yan He, Pfizer, Inc. and Cristina Montealegre, Solvias AG

Session Speaker:

Comparison of CE-SDS Platforms to Quantitate Purity and Viral Protein Ratios of Adeno-associated Virus (AAV) Capsids  

Kaixiang Huang, Eli Lilly & Company

Development and Troubleshooting of a CGE Method for Analysis of AAV Capsid Protein Purity

Gordon Freckleton, Bristol Myers-Squibb Company

Performance Assessment of an Improved CE Kit for Plasmid DNA Characterization in mRNA Therapeutic Development

Ryan Nai, CSL

The following vendor partners will each present a 5-minute presentation on their company's products and services. Join to learn more about our exhibitors and how they can help better serve you and your customers. 

Greg Manley, SCIEX

Matthew Courtney, Advanced Electrophoresis Solutions Ltd.

Session Chairs: Jacek Cieslak, CDER, FDA and Tara Enda, Bristol-Myers Squibb Company

Session Speakers:

Emerging Technologies – FDA Process for Collaborating with Industry Partners to Introduce New Technologies

Anjali Shukla, CDER, FDA

Regulatory Considerations for Early-Stage Cell and Gene Therapies

Elvira Argus, CBER, FDA

The following vendor partners will each present a 5-minute presentation on their company's products and services. Join to learn more about our exhibitors and how they can help better serve you and your customers. 

Ed Chase, Bio-Techne

Supporting Biomolecule Analysis

Steve Siembieda, Agilent Technologies, Inc.

Grab some breakfast and join us for a technical seminar presented by Agilent Technologies, Inc. 

Breakfast will be served until 8:30am

mRNA Integrity by Agilent 5300 Fragment Analyzer

Shauna Salem, Pfizer, Inc. 

Session Chairs: Steffen Kiessig, ten23 Health AG and Kathir Muthusamy Regeneron Pharmaceuticals Inc. 

Session Speakers:

Establishment of Single Streamlined Automated Workflow Enabling Concurrent Execution of Fragment Analysis and Ribogreen for Assessment of Quality and Quantity of mRNA in a Single Seamless Run

Kanwal Gill, Pfizer, Inc. 

High-Throughput Capillary Electrophoresis of Several Biopharmaceutical Modalities Using the SCIEX Biophase 8800 

John Orlet, Pfizer, Inc. 

Too Much Sugar! A Case Study for CE Development of a Complex Fusion Protein

Mark Haverick, Merck and Co. 

The following vendor partners will each present a 5-minute presentation on their company's products and services. Join to learn more about our exhibitors and how they can help better serve you and your customers. 

Bob Swart, Revvity

Maksim Sliadnev, Lumex Instruments Canada

Integration of CEInfinite icIEF for the Expansion of Subsequent Analysis Strategies

Gianna Pescatore, Eli Lilly and Company and Xiaoxi Zhang, Thermo Fisher Scientific

Session Chairs: Timothy Blanc, Eli Lilly and Company and Bernd Moritz, F. Hoffmann-La Roche Ltd.

Session Speaker:

Integration of Electropherograms in GMP Labs Under Increasing Scrutiny Due to Data Integrity Intensive Inspections

Hermann Watzig, Braunschweig Technical University 

Optimizing a Chip-Based Capillary Electrophoresis Method for Rapid Protein Characterization

Gregory Schlobohm, Amgen Inc.

Sodium Dodecyl Sulfate - Capillary Agarose Gel Electrophoresis of Therapeutic Proteins: Ultrafast Separations With No Baseline Humps

Dániel Sárközy, Applied Bioanalytics Ltd. 

The following vendor partners will each present a 5-minute presentation on their company's products and services. Join to learn more about our exhibitors and how they can help better serve you and your customers. 

Analysis at the Speed of Life

Hampus Engstroem, 908 Devices