COMPOSITION AND METHOD FOR STABILIZING BIOLOGICAL MOLECULE UPON LYOPHILIZATION

摘要

PROBLEM TO BE SOLVED: To provide compositions and methods for stabilizing biological molecules upon lyophilization. SOLUTION: The invention is directed to compositions and methods for the preparation of biological molecules, in particular MenC-CRM 197. Biological molecules dissolved in dissolution buffers comprising at least one amorphous excipient and an amorphous buffer exhibit reduced aggregation and proteolytic breakdown. According to one aspect, there are provided at least one amorphous excipient, at least one amorphous buffer and at least one dissolution buffer comprising a MenC immunogen. COPYRIGHT: (C)2011,JPO&INPIT