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Ectoine and hydroxyectoine stabilize antibodies in spray dried formulations at elevated temperature and during freeze-thaw process.

Maintenance of protein stability during manufacture, storage and delivery is necessary for the successful development of a drug product. Herein, the utility of two compatible solutes - ectoine and hydroxyectoine - in stabilizing a model protein labelled Fab2 has been investigated. Specifically, the performance of ectoine and hydroxyectoine in stabilizing Fab2 in spray dried formulation at elevated temperature and after multiple freeze-thaw cycles has been compared with the performance of a formulation containing trehalose and a formulation containing no excipient as controls. In solid state at 90C and 37C and in freeze concentrate systems, ectoine and hydroxyectoine suppress protein aggregation. Like trehalose, hydroxyectoine also limits N-terminal pyroglutamate formation in Fab2 in solid state. The extent of protein stabilization is dependent on excipient concertation in the formulation, but at 1:1 excipient to protein mass ratio, hydroxyectoine is better than trehalose in stabilizing Fab2. The results presented here suggest that ectoine and hydroxyectoine are effective excipients for stabilizing therapeutic antibodies.