ABSTRACT
This chapter reviews how human insulin became the first human health product of DNA technology. It discusses some of the special problems, in terms of regulatory environment and public opinion that had to be overcome in order to bring it to the current stage of development. With recombinant DNA production of human insulin, almost 100 percent of the cells produce the desired gene product. Because of the method of manufacture, none of the pancreatic contaminants of the animal insulins are found in the human insulin of recombinant origin. Concerns about the containment of potentially harmful organisms fell under the purview of the Recombinant DNA Advisory Committee and the National Institute of Occupational Safety and Health. Recombinant DNA Advisory Committee, established in 1974 by the secretary of Health, Education and Welfare, had 11 members, all of whom were scientists.
