Stability of a high-concentration monoclonal antibody solution produced by liquid-liquid phase separation.

ABSTRACT: Subcutaneous injection of a low volume (<2 mL) high concentration (>100 mg/mL) formulation is an attractive administration strategy for monoclonal antibodies (mAbs) and other biopharmaceutical proteins. Using concentrated solutions may also be beneficial at various stages of bioprocessing. However, concentrating proteins by conventional techniques, such as ultrafiltration, can be time consuming and challenging. Isolation of the dense fraction produced by macroscopic liquid-liquid phase separation (LLPS) has been suggested as a means to produce high-concentration solutions, but practicality of this method, and the stability of the resulting protein solution have not previously been demonstrated. In this proof-of-concept study, we demonstrate that LLPS can be used to concentrate a mAb soluti

SUBMITTER: Bramham JE 

PROVIDER: S-EPMC8265796 | biostudies-literature | 2021 Jan-Dec

REPOSITORIES: biostudies-literature