Evaluation of solvent systems for optimized extractables studies of single use bioprocessing solutions.

Despite their advantages, there is concern that single-use systems used in biopharmaceutical manufacture might release potentially toxic substances during standard unit operations that negatively impact cell growth. Characterization of the extractables profile for single-use systems is necessary to know which compounds potentially become leachables under operational cell culture conditions. A key issue in the design of extractables studies is the composition of the model solvent, in particular its pH and polarity. In this study, a new approach, based on design of experiments (DoE), has been applied to determine the composition of the model solvent for extractable profiling of single-use bags (SUBs). Particular focus was placed on the determination of the degradation products of the antioxidant Irgafos 168