A universal tool for stability predictions of biotherapeutics, vaccines and in vitro diagnostic products
M. Huelsmeyer, Drago Kuzman, Matjaž Bončina, Jérôme Martinez, Christophe Steinbrugger, Jos Weusten, Cesar Calero‐Rubio, Warren Roche, Birgit Niederhaus, Y. VanHaelst, M. Hrynyk, P. Ballesta, H. Achard, Silva Augusto, M. Guillois, C. Pszczolinski, Maxim A. Gerasimov, C. Neyra, D. Ponduri, S. Ramesh, Didier Clénet
Abstract
It is of particular interest for biopharmaceutical companies developing and distributing fragile biomolecules to warrant the stability and activity of their products during long-term storage and shipment. In accordance with quality by design principles, advanced kinetic modeling (AKM) has been successfully used to predict long-term product shelf-life and relies on data from short-term accelerated stability studies that are used to generate Arrhenius-based kinetic models that can, in turn, be exploited for stability forecasts. The AKM methodology was evaluated through a cross-company perspective on stability modeling for key stability indicating attributes of different types of biotherapeutics, vaccines and biomolecules combined in in vitro diagnostic kits. It is demonstrated that stability predictions up to 3 years for products maintained under recommended storage conditions (2-8 °C) or for products that have experienced temperature excursions outside the cold-chain show excellent agreement with experimental real-time data, thus confirming AKM as a universal and reliable tool for stability predictions for a wide range of product types.