The method most commonly used for pharmaceutical protein products is lyophilization.The classification, characters, and mechanism of denaturation protein on Freeze-dry process are thorough discussed.

• 冷冻干燥是制备蛋白质药物常用方法.；详细综述了冷冻干燥过程中导致蛋白质变性机理的种类、特征、原理;