High-throughput formulation development presents a unique opportunity for the rationalization of results and the formation of predictive models using quantitative modeling. By screening libraries of structurally similar compounds, quantitative structure-property relationship (QSPR) methodologies can be applied to large stability datasets to inform potential mechanisms of biochemical degradation. In this study, we measured the effects of different carboxylic acid buffers on the chemical degradation rates of an IgG1 monoclonal antibody (mAb) and model peptide using high throughput methods. The results demonstrate that chemical degradation rates of the mAb and model peptide were affected by the structure of the carboxylic acid buffers. To understand the specific structural and physicochemical properties of carboxylic acids which were responsible for the observed differences in chemical degradation rates, we implemented quantitative structural analysis. The results demonstrate the effectiveness of various carboxylic acid descriptors as determinants for the observed chemical degradation rates.

Effects of carboxylate buffer structure on chemical degradation of proteins: Application of QSPR to high throughput formulation development

245th National Meeting (2013)

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