Characterization of Forced-Degraded Antibodies Using Advanced Analytics for Higher-Order Structure-Assessment

Forced degradation studies are an integral part of protein therapeutics research and development. Identification of the protein degradation pathways and the characterization of the higher-order structure (HOS) is critical in estimating the biological function, efficacy, and safety of biotherapeutics. A powerful tool for precise and high throughput characterization of the biotherapeutics is therefore of high value in the industry. Here we will delve into recent advances in characterization tools for assessing HOS with a focus on case studies involving force degraded antibodies. Antibody fragmentation and aggregation can be detected and quantified by automated mass photometry. This technique can detect a low count of high mass aggregate species and can identify antibodies having different physiochemical properties leading to aggregation in response to stress conditions.