Therapeutic antibodies represent the most common class of biopharmaceutical drug products today due to their high efficacy and low level of adverse effects. Despite apparent clinical benefits, antibody aggregates generated during production, purification, filling into vials or syringes, and the shipping and storage of antibody solutions have become a major issue to be solved because protein aggregates may induce immunogenicity, having a potential risk for patients. As a result, the presence of aggregated antibodies needs to be properly monitored and the amount should be minimized, as is required from regulatory agencies.
Creative Biolabs holds a world-leading position in the development and characterization of therapeutic antibodies. Based on our extensive experience and state-of-the-art technology platforms, we can get your antibody candidates well-characterized in terms of affinity, post-translational modifications, purity, aggregation, etc. Here, we introduce the application of sedimentation velocity analytical ultracentrifugation (SV-AUC) for antibody aggregation analysis.
SV-AUC is an analytical ultracentrifugation method that measures the sedimentation rate at which molecules move in response to the centrifugal force generated in a centrifuge. The sedimentation velocity depends on the instrument settings (angular velocity), the molecule properties (e.g., mass, density, and shape), and the carrier solution (density, viscosity). Sedimentation velocity is particularly valuable for:
Fig.1 SV-AUC for antibody aggregation analysis.
From the early 21st century, SV-AUC has begun to be well recognized and adopted by the pharmaceutical industry to quantitatively characterize antibody aggregates, in particular, soluble antibody aggregates with diameters less than 100 nm, i.e. nanometer particles. An important strength of SV-AUC is its ability to detect aggregates without any change in solution condition as long as the formulation components do not interfere with the detection, which cannot be achieved by size-exclusion chromatography (SEC), the standard method for aggregation analysis. Therefore, SV-AUC acts as a complementary method to SEC to ensure that this routine method is not altering the true aggregate population prior to detection.
Moreover, as antibody aggregates range from tens of nanometers to hundreds of micrometers and no instrument can provide information covering the whole size range. In addition, no protein aggregate standards of known particle size and concentration are available. Therefore, the evaluation of protein aggregates using orthogonal methods based on different detection principles is recommended. Creative Biolabs is able to use a broad spectrum of analytical techniques to offer a comprehensive evaluation of aggregation, including but not limited to:
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