Hsu C C, Walsh A J, Nguyen H M, Overcashier D E, Koning-Bastiaan H, Bailey R C, Nail S L
Department of Pharmaceutical Research, Genentech, Inc., South San Francisco, CA 94080, USA.
J Pharm Sci. 1996 Jan;85(1):70-4. doi: 10.1021/js950255o.
A light microscopy system has been designed for freezing and lyophilization studies of protein pharmaceuticals. The system consists of a cascade of four Peltier thermoelectric modules in the lyophilization cell to freeze samples to -60 degrees C, controllers to regulate temperature and pressure conditions, and a video camera to record the events under study. Specific demonstration of the system was conducted using recombinant CD4-IgG and human growth hormone (hGH) as model proteins. Observations of recrystallization during warming of frozen CD4-IgG solution and lyophilization of hGH solution are discussed. These examples demonstrate that the system is a useful tool for the fundamental understanding of freezing and lyophilization of protein pharmaceuticals.
已设计出一种用于蛋白质药物冷冻和冻干研究的光学显微镜系统。该系统由冻干单元中的四个级联珀耳帖热电模块组成，用于将样品冷冻至-60摄氏度；由控制器调节温度和压力条件；还有一个摄像机记录所研究的过程。使用重组CD4-IgG和人生长激素（hGH）作为模型蛋白对该系统进行了具体演示。讨论了冷冻的CD4-IgG溶液升温过程中的重结晶现象以及hGH溶液冻干过程中的重结晶现象。这些实例表明，该系统是从根本上理解蛋白质药物冷冻和冻干过程的有用工具。
