Examining the freezing process of an intermediate bulk containing an industrially relevant protein

The present study shows that freezing of a buffered intermediate bulk containing a biopharmaceutically relevant protein during a bottle freezing process describes a very complex process where product loss is caused by a synergistic effect of ion redistribution and pH changes. Only if the local redistribution of both, ion concentrations and pH values, are known, product loss may be calculated and minimized by optimizing the freezing process.