Author:
Huelsmeyer M.,Kuzman D.,Bončina M.,Martinez J.,Steinbrugger C.,Weusten J.,Calero-Rubio C.,Roche W.,Niederhaus B.,VanHaelst Y.,Hrynyk M.,Ballesta P.,Achard H.,Augusto S.,Guillois M.,Pszczolinski C.,Gerasimov M.,Neyra C.,Ponduri D.,Ramesh S.,Clénet D.
Abstract
AbstractIt 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.
Publisher
Springer Science and Business Media LLC
Reference46 articles.
1. ICH, Q1A(R2). Stability Testing of New Drug Substances and Products, Step 4 (2003).
2. ICH, Q1E. Evaluation for Stability Data, Step 4 (2003).
3. Schofield, T. Maintenance of vaccine stability through annual stability and comparability studies. Biologicals 37, 397–402 (2009).
4. Schofield, T. & Krause, P. R. Stability evaluation of vaccines. Biologicals 37, 355 (2009).
5. Moriconi, A. et al. A new strategy for preparing a tailored meningococcal ACWY conjugate vaccine for clinical testing. Vaccine 38, 3930–3933 (2020).
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