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Aggregation is an important quality attribute of many protein-based biopharmaceuticals, including monoclonal antibodies (mAbs), that can influence product efficacy and safety; as such monitoring of aggregation levels is therefore essential.

Size exclusion chromatography (SEC) is widely considered to be the gold standard analytical tool for assessing nanometer-sized aggregates and is often combined with multi-angle light scattering (MALS) to enable the determination of molecular weight and size. However, the technique can be complicated by several factors, including column and mobile phase optimization. 

Mass photometry is a novel, label-free analytical tool based on detecting light scattered by single molecules, enabling the monitoring of the molecular mass of biomolecules in solution. This technique can analyze small (µL) sample volumes and concentrations (100 pM up to 100 nM) under native conditions within a short analysis time of a few minutes.

In the presented analysis, both SEC and mass photometry were used to measure aggregation levels of trastuzumab, a monoclonal antibody, and several trastuzumab biosimilars. The results of this short study demonstrate that SEC and mass photometry are complementary, highlighting the usefulness of mass photometry as an orthogonal technique for monitoring aggregation of biopharmaceuticals such as mAbs.

The presentation will discuss the pros and cons of each technology and summarize some of the factors that should be considered when analyzing and comparing data generated by these different techniques.

A live Q&A session followed the presentation, offering a chance to pose questions to our expert panelist.

Gareth Rogers
Gareth Rogers, PhD
Director, Product Management & Manager – Advanced Development

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