Simplified kinetic modeling for predicting the stability of complex biotherapeutics.

ABSTRACT: Stability studies are vital in biologics development, guiding formulation, packaging, and shelf life determination. Traditionally, predicting long-term stability based on short-term data has been challenging due to the complex behavior of biologics. However, recently have been demonstrated that by using simple kinetics and the Arrhenius equation, it is possible to achieve accurate long-term stability predictions for various quality attributes, including protein aggregates. This study focuses on effective modeling of aggregate predictions for diverse protein modalities, such as IgG1, IgG2, Bispecific IgG, Fc fusion, scFv, bivalent nanobodies, and DARPins, using a first-order kinetic model. Notably, findings highlight the significance of temperature selection in stability studies, enabling t

SUBMITTER: Zidar M 

PROVIDER: S-EPMC12214494 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature