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Development of a platform SEC-MALS method for therapeutic monoclonal antibodies

Waters | Wyatt Technology
6 May 2025

In biotherapeutics manufacturing, controlling the size distribution of therapeutic monoclonal antibodies (mAbs) is critical to ensuring product quality. Size-exclusion chromatography coupled to multi-angle light scattering (SEC-MALS) is a leading method for analyzing size variants by separating high and low molecular weight species from the monomer based on their hydrodynamic volume.

Learn how the analytical team at Tanvex BioPharma, Inc. found SEC-MALS to be an advantageous method which is cost-effective and efficient for analyzing size variants across a broad range of mAbs.

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DAWN™

Waters | Wyatt Technology

The DAWN is the premier Multi-Angle static Light Scattering (MALS) detector for absolute characterization of the molar mass and size of macromolecules and nanoparticles in solution, offering the highest sensitivity and widest range of molecular weight, size, concentration and optional features.

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Size Exclusion ChromatographySize exclusion chromatography (SEC) is a liquid chromatographic technique used to separate and identify molecules based on their size, including polymers, proteins, nanoparticles & nucleic acid. SEC is further subdivided into gel filtration chromatography (GFC) and gel permeation chromatography (GPC) when an aqueous or organic mobile phase is used respectively. HPLC-based SEC systems and columns are available for analytical separation alongside SEC spin columns or filters to prep samples for many protocols. Find the best size exclusion chromatography equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Monoclonal AntibodiesMonoclonal antibodies (mAbs) are lab-made molecules that can bind to specific antigens on cells, making them highly effective in treating cancers, autoimmune diseases, and infections. These targeted therapies are transforming the treatment landscape for many conditions. Browse our peer-reviewed product directory to find monoclonal antibodies for research and clinical applications; compare products, check reviews, and get pricing directly from manufacturers.BiopharmaceuticalsBiopharmaceuticals are proteins and other compounds (such as nucleic acids) produced by living organisms that have uses as therapeutics or for in vivo diagnostics. The most well known example of a biopharmaceutical product, and the first to be approved for therapeutic use, was recombinant human insulin.

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Development of a platform SEC-MALS method for therapeutic monoclonal antibodies