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The first synthetic drug, acetylsalicylate, produced in 1895 and patented as aspirin [1] (Bayer in 1900), marks the beginning of the modern pharmaceutical industry. Throughout the early to mid-1900s there was significant emphasis on development of synthetic antibiotics for infectious diseases and small organic molecules, which continues to this day as the mainstay of the traditional (small-molecule) pharmaceutical industry. Advances in understanding the mechanism of reproductive functions and metabolic diseases, such as diabetes and short stature, led to the discovery of polypeptide hormones. The early polypeptide hormone drugs were purified from organs, such as insulin from animal pancreas or growth hormone from cadaver pituitary. The first animal-derived insulin preparation to become commercially available was Iletin, derived from bovine or porcine sources (Eli Lilly in 1923) [2]. Growth hormone, which had to be derived from a human source, was originally produced by special order in hospital laboratories and only commercialized much later in the United States in 1976 [3]. Although these products were breakthroughs in the treatment of diabetes and dwarfism, there were serious limitations with this type of production, including availability of organs and issues with transmission of infectious diseases [4]. |
