Stable lyophilized therapeutic protein compositions and their methods of manufacture are provided. Specifically, the use of water as a solid cake plasticizer and protein stabilizer is described. Also, the inclusion of a multicomponent stabilizer comprising a larger molecular entity and a smaller molecular entity is described. Also, the inclusion of post-drying annealing under certain conditions improves protein stability. Proteins are predicted to remain stable over 24 months at 25℃.本發明提供穩定的冷凍乾燥治療性蛋白質組合物及其製造方法。具體而言，描述水作為固體餅塑化劑及蛋白質穩定劑之用途。亦描述包含較大分子實體及較小分子實體之多組分穩定劑的納入。此外，在某些條件下的乾燥後退火之納入改善蛋白質穩定性。蛋白質經預測在25℃下保持穩定達24個月。
