Can Controlled Ice Nucleation Improve Freeze-Drying of Highly-Concentrated Protein Formulations?

Journal of Pharmaceutical Sciences

Authors: 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.

https://jpharmsci.org/article/S0022-3549(15)30851-0/fulltext