ASSAY FOR DETERMINING POTENTIAL TO SELF-ASSOCIATION OF A PROTEIN USING CONCENTRATION-DEPENDENT SELF-INTERACTION NANOPARTICLE SPECTROSCOPY

摘要

Methods for producing high concentration protein formulations having high stability are provided. Assays for selecting proteins and formulation conditions that have high self-repulsive attributes are used as an early step in the manufacturing process. Specifically, a protein concentration-dependent self-interaction nanoparticle spectroscopy method is employed as a protein colloidal interaction assay.