Characterization of highly concentrated antibody solution - A toolbox for the description of protein long-term solution stability.

ABSTRACT: High protein titers are gaining importance in biopharmaceutical industry. A major challenge in the development of highly concentrated mAb solutions is their long-term stability and often incalculable viscosity. The complexity of the molecule itself, as well as the various molecular interactions, make it difficult to describe their solution behavior. To study the formulation stability, long- and short-range interactions and the formation of complex network structures have to be taken into account. For a better understanding of highly concentrated solutions, we combined established and novel analytical tools to characterize the effect of solution properties on the stability of highly concentrated mAb formulations. In this study, monoclonal antibody solutions in a concentration range of 50-20

SUBMITTER: Schermeyer MT 

PROVIDER: S-EPMC5627599 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature