文摘
It had been discovered that crystals of α-lactose monohydrate can occlude and give kinetic stability to various proteins, an unexpected observation suggesting a process for storing protein vaccines and biopharmaceuticals at room temperature. The growth of α-lactose monohydrate with proteins is analyzed herein, emphasizing segregation coefficients, the relationships between protein incorporation and buffer composition, temperature, growth rate, and mass transport. Detailed examination of bovine serum albumin is supported by data for eight other proteins. A search for other crystals with lactose-like inclusivity of macromolecular guests is also reported.