Chance R E, Frank B H
Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana.
Diabetes Care. 1993 Dec;16 Suppl 3:133-42. doi: 10.2337/diacare.16.3.133.
This paper provides some historical aspects on the research and development of Humulin (rDNA origin), the first human health-care product derived from rDNA technology more than a decade ago. Also referred to as biosynthetic human insulin, Humulin is currently produced via the human proinsulin route, using an Escherichia coli fermentation process. The authenticity, high purity, and safety of BHI has been investigated and verified by a complex battery of analytical and physicochemical methods. The daily treatment of more than two million diabetic patients worldwide with this rDNA human insulin not only demonstrates the value of rDNA technology in providing an important medical product, it is assurance that diabetic patients will have unlimited supplies of this vital hormone as well as potential analogue refinements.
本文介绍了十多年前首个源自重组DNA技术的人类保健产品优泌林(重组DNA来源)研发的一些历史情况。优泌林也被称为生物合成人胰岛素,目前通过人胰岛素原途径,利用大肠杆菌发酵工艺生产。已通过一系列复杂的分析和物理化学方法对优泌林的真实性、高纯度和安全性进行了研究和验证。全球超过两百万糖尿病患者每天使用这种重组DNA人胰岛素,这不仅证明了重组DNA技术在提供重要医疗产品方面的价值,也确保糖尿病患者将能获得这种重要激素的无限供应以及潜在的类似物改进产品。