Assessing and controlling aggregation of biologics is vital to ensure the safety and efficacy of a biopharmaceutical product. In addition, aggregation has been recognized as a major issue for modern therapeutic modalities such as bispecific antibodies and Fc fusion proteins. Therefore, checking for aggregation propensity is an essential part of developability assessments throughout the development cycle, starting from in silico approaches in the protein design phase to experimental confirmation and analysis in the discovery and upstream and downstream development stages.
In these stages, hundreds of samples need to be analyzed. These numbers pose a big challenge for current analytical approaches (mainly size exclusion chromatography, SEC), which are slow and require sample purification. We have addressed this bottleneck by developing a high throughput aggregation screening assay that allows the assessment of aggregation of molecules containing the antibody Fc domain in different sample matrices and cell culture supernatants. This is the first assay capable of screening hundreds of samples within two hours and without purification of samples. We are presenting different data sets from forced aggregation studies and data from Biopharma development partners.