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Although Herbert Wayne Boyer, Stanley Norman Cohen, and their colleagues developed the basic techniques of gene splicing and genetic engineering, it was Boyer who orchestrated the development of these techniques into ones that could be exploited in the production of medicinally important proteins and enzymes, leading to the birth of the biotechnology and biopharmaceutical industries.

Financier Robert Swanson thought that the techniques could be used to produce human insulin, a protein that would be needed in the near future since the number of diabetics in the United States was increasing while the supply of bovine and porcine pancreases from which diabetics received their insulin was decreasing. Boyer and Swanson founded Genentech to produce human insulin. The Swanson-Boyer Genentech team elicited the assistance of Arthur Riggs and his colleagues at the City of Hope clinical research hospital in Duarte, California, in the project. Since the use of human DNA in recombinant DNA experimentation was not permitted by the National Institutes of Health guidelines involving recombinant DNA research, the Genentech-City of Hope team thought that the best approach was to synthesize the human insulin "gene" rather than to isolate it. Under a loophole in the guidelines, the use of a synthetic human gene in constructing recombinant DNA molecules would not be banned. The strategy was to synthesize, clone, and express in Escherichia coli (E. coli) bacteria cells a human gene that would code for human insulin.

Riggs suggested that he and his colleagues Keiichi Itakura, Herb Heyneker, and John Shine first synthesize, clone, and express the human somatostatin gene since somatostatin was considerably smaller--fourteen amino acids compared to insulin's fifty-one amino acids. This project was completed in August, 1977, and published in December, 1977.

Soon after the somatostatin project was completed, the Genentech-City of Hope team, with the assistance of Itakura, David Goeddel, Dennis Kleid, and Roberto Crea, began the human insulin project. Since insulin is composed of two polypeptide chains, the strategy was to synthesize, clone, and express separately in E. coli a gene coding for each chain. The chains would then be isolated, mixed, joined, and folded into a functioning insulin molecule. On September 6, 1978, Genentech and City of Hope announced that they had successfully cloned and expressed the human insulin gene in E. coli. Twelve days earlier on August 25, Genentech licensed the production of human insulin to Eli Lilly. In 1980, a small-scale clinical trial involving fourteen patients was begun in England, followed by a much larger clinical trial in the United States in 1982. Human insulin became the first human protein of medicinal value to be produced by genetic-engineering techniques and approved for use by the U.S. Food and Drug Administration (FDA). The FDA-approved the use of human insulin, marketed under the name Humulin, on October 29, 1982.

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