Method Robustness and Transferability for Modern Size-Exclusion Methods

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, because SEC is a non-adsorptive separation modality, it may be unclear as to which method parameters to adjust for the optimal separation of monomer, aggregate, and fragment.

In this presentation, we discuss SEC method experimental design space. Column selection, mobile phase, flowrate, and injection volume are all discussed to ensure optimal separation of monomer, aggregate, and fragment of mAbs and other mAb formats.

Webinar Learning Objectives:

• Learn about a breakthrough in SEC column development to improve method robustness for monoclonal antibodies and related recombinant proteins
• Understand how column choice‑including exclusion limit, particle size, and column length may affect chromatographic performance
• Determine a practical mobile phase screen to optimize mAb aggregate recovery, fragment separation and understand when organic solvent should be used and how other co-solvents may be beneficial in improving peak shape and recovery

Presenter: Helen Whitby, PhD (Senior Product Manager – Biopharma, Phenomenex)

Helen has a PhD in synthetic organic and analytical chemistry from the University of Manchester, UK and has worked at Phenomenex for the last 15 years specialising in HPLC and Bioseparations.