Lyophilization of Protein Pharmaceuticals

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Abstract
There are numerous unique, critical applications for proteins in human healthcare. Many protein drugs are already on the market, and over 200 candidate proteins and peptides are currently in clinical trials (Geisow 1992; Wang and Pearlman 1993; Talmadge 1993). However, even the most promising and effective protein therapeutic will not be of benefit to human health, if its stability cannot be maintained during packaging, shipping, long-term storage, and administration. For ease of preparation and cost containment by the manufacturer, and ease of handling by the end user, an aqueous protein solution is often the preferred formulation. Unfortunately, water fosters protein degradation by providing a medium for molecular movement and conformational perturbations, as well as serving as a reactant in chemical degradation pathways (e.g., hydrolysis).

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