Can controlled ice nucleation improve freeze-drying of highly-concentrated protein formulations?

Geidobler R, Konrad I, Winter G.

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.

J Pharm Sci. 2013 NOV

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