Analysis of antibody aggregate content at extremely high concentrations using sedimentation velocity with a novel interference optics.

ABSTRACT: Monoclonal antibodies represent the most important group of protein-based biopharmaceuticals. During formulation, manufacturing, or storage, antibodies may suffer post-translational modifications altering their physical and chemical properties. Such induced conformational changes may lead to the formation of aggregates, which can not only reduce their efficiency but also be immunogenic. Therefore, it is essential to monitor the amount of size variants to ensure consistency and quality of pharmaceutical antibodies. In many cases, antibodies are formulated at very high concentrations > 50 g/L, mostly along with high amounts of sugar-based excipients. As a consequence, all routine aggregation analysis methods, such as size-exclusion chromatography, cannot monitor the size distribution at thos

SUBMITTER: Schilling K 

PROVIDER: S-EPMC4372433 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature