Method Robustness and Transferability for Modern Size-Exclusion Methods



Thursday, August 26, 2021 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST Developing a robust, transferable size-exclusion chromatography (SEC) method for routine testing of mabs and other biotherapeutics can be challenging. Join us for this presentation to learn about SEC method development, with an emphasis on method transfer and sustainability.

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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


Brian Rivera
Senior Product Manager- Biologics

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