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Method Development for

Modern Size Exclusion Chromatography

with Brian Rivera

Senior Product Manager- Biologics,

Phenomenex

Date: 26 October, 2021 | Tuesday

Time: 11:00 SGT (UTC +8)/ 14:00 AEDT (UTC +11)

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.

Key Learning Points:

Learn how 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 and fragment separation
Understand when organic solvent should be used and how other co-solvents, including arginine, may be beneficial in improving peak shape and recovery

Who Should Attend:

Analytical R&D chemists interested in improving updating a platform or legacy SEC
Development labs interested in transferring robust, high-quality data and methods to CDMO partners
Anyone new to aggregate analysis for mAbs and related mAb formats

About the Speaker:

Brian Rivera is a Senior Product Manager at Phenomenex, with over 15 years in HPLC analysis of large molecules. Before joining Phenomenex, his previous industry experience includes positions at Chiron Corporation (now Novartis), ProZyme (now Agilent), and Avid Bioservices, performing protein purification as well as analytical methods development and in-process analytical support. His primary focus was on protein characterization by size exclusion, glycan mapping, and intact reversed phase HPLC methods.

He has a Bachelor’s Degree from the University of California, Davis.

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