The aim of this study was to investigate if controlled ice nucleation with our previouly published method is applicable to highly-concentrated protein formulations of bovine serum albumin (100 mg/ml and 193.9 mg/ml) and a monoclonal antibody (161.2 mg/ml) and if positive effects on primary drying time as well as reconstitution times can be achieved. We observed that for both proteins, ice nucleation at a product temperature of -5 °C significantly reduced primary drying time. Furthermore, reconstitution times of the lyophilized cakes could be shortened, especially for the monoclonal antibody formulation with a reconstitution time of 5 minutes instead of 15 minutes.
Keywords: controlled ice nucleation; dissolution; freeze-drying; lyophilization; proteins; wetting.
© 2013 Wiley Periodicals, Inc. and the American Pharmacists Association.