Determine the Stability of Biologics
This peer review article from American Pharmaceutical Review describes new tools for determining the stability of biologics, including ARGEN by Fluence Analytics, that not only have low sample requirements but also generate precise and reproducible data to effectively implement an advanced design of experiments approach. This article uses a real case study using an IgG 1 antibody to illustrate how to properly combine some of these new high-throughput tools with a novel approach to formulation development that considers the key factors and forces that impact physical stability of proteins in solution. The article emphasizes high-throughput, low sample requirement strategies that are useful for industrial application.