Control of viscosity in biopharmaceutical protein formulations.

Journal of Colloid and Interface Science
Mitja ZidarMiha Ravnik

Abstract

Controlling the viscosity of concentrated protein solutions - usually reducing - is an open challenge, with major recent relevance in protein formulations for biopharmaceutical, medical, food, and other applications. The addition of viscosity-reducing additives generally not only changes the viscosity of the protein solutions but also the actual secondary/tertiary structure of the proteins, which is usually highly undesirable, and can be even toxic in systems, such as for biopharmaceutical applications. Therefore, it is of major importance to be able to establish control over the combination of viscosity-affecting additives and adequate protein stability, usually at high protein concentrations. Here, we demonstrate the control and manipulation of the viscosity profile of a selected protein solution (monoclonal antibody of immunoglobulin gamma type IgG) of direct biopharmaceutical relevance, by identifying elementary viscosity contributions via selected additives that target different protein-protein interactions. Specifically, a combined study of viscosity control and protein aggregation is performed with viscosity characterized by microfluidic measurements and protein aggregation by size-exclusion chromatography, where aggrega...Continue Reading

Citations

Mar 13, 2021·Trends in Biotechnology·Antonio Gaetano CardilloChristos Varsakelis

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