In-situ biophysical characterization of high-concentration protein formulations using wNMR.

ABSTRACT: High-concentration protein formulation is of paramount importance in patient-centric drug product development, but it also presents challenges due to the potential for enhanced aggregation and increased viscosity. The analysis of critical quality attributes often necessitates the transfer of samples from their primary containers together with sample dilution. Therefore, there is a demand for noninvasive, in situ biophysical methods to assess protein drug products directly in primary sterile containers, such as prefilled syringes, without dilution. In this study, we introduce a novel application of water proton nuclear magnetic resonance (wNMR) to evaluate the aggregation propensity of a high-concentration drug product, Dupixent® (dupilumab), under stress conditions. wN

SUBMITTER: Song J 

PROVIDER: S-EPMC10841025 | biostudies-literature | 2024 Jan-Dec

REPOSITORIES: biostudies-literature