Simple sugars, especially disaccharides, stabilize and preserve therapeutic proteins of various composition both in their liquid and solid states. Therapeutic proteins are normally formulated at a wide range of concentrations and undergo process development, storage, and administration at various temperatures. In most cases, freeze-drying is the preferred method to manufacture therapeutic proteins in their solid state, thus the understanding of the correlation among excipient properties, formulation composition, processing conditions and lyophilized cake properties remains of great interest. Moreover, the stability of the lyophilized cake as function of storage temperature is critical to developing a robust formulation with desirable biological performance. The present study aims to understand the properties of Vialose ultra-pure trehalose and investigate its impact on the preparation and stabilization of lyophilized cakes, in the presence and absence of a model therapeutic protein, bovine serum albumin (BSA). Sucrose was selected as a benchmark to compare their properties and performance in preserving /stabilizing lyophilized BSA.
