Method Robustness and Transferability for Modern Size-Exclusion Methods

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Event Overview:

Size-exclusion chromatography (SEC) is a well-established analytical method for quantitative and qualitative aggregate analysis of monoclonal antibodies (mAbs) and other related biotherapeutics. However, developing a robust, transferable SEC method for routine testing can be challenging for any analytical development laboratory. This is particularly difficult as one considers different LC instrumentation, transitioning from a legacy SEC method, or defining which method parameters will demonstrate robustness.

In this presentation, we discuss SEC method development, with an emphasis on method transfer and sustainability. U/HPLC system configurations, differences in SEC column chemistries, and experimental method parameters are explored to ensure the analytical method demonstrates robustness and can be sustained to support the entirety of a biotherapeutic life cycle.

Key Learning Objectives:

• Understand the impact of U/HPLC systems, including bio-inert and traditional stainless-steel configurations, on obtaining robust and reproducible aggregate analysis data by SEC
• Understand how to transition from a legacy SEC method to improve analytical method throughput and data quality
• Determine the experimental parameters to vary to ensure demonstration of analytical method robustness

Who Should Attend:

• Analytical R&D chemists transferring methods to other laboratories, including QC lot release testing and/or CDMO partners
• Analytical method developers challenged with updating a platform or legacy SEC
• Anyone new to aggregate analysis for mAbs and related mAb formats

Speakers

Brian Rivera
Senior Product Manager- Biologics
Phenomenex

Register Free: https://www.chromatographyonline.com/lcgc_w/robustness