RESEARCH, DEVELOPMENT, PRODUCTION, AND SAFETY OF BIOSYNTHETIC HUMAN INSULIN

This paper provides some historical aspects on the research and develo pment of Humulin(R) (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(R) is currently produced via t he human proinsulin route, using an Escherichia coli fermentation proc ess. The authenticity, high purity, and safety of BHI has been investi gated and verified by a complex battery of analytical and physicochemi cal methods. The daily treatment of more than two million diabetic pat ients worldwide with this rDNA human insulin not only demonstrates the value of rDNA technology in providing an important medical product, i t is assurance that diabetic patients will have unlimited supplies of this vital hormone as well as potential analogue refinements.