Bovine Somatotropin - History

History

In 1937, the administration of BST was shown to increase the milk yield in lactating cows by preventing mammary cell death in dairy cattle. Until the 1980s, there was very limited use of the compound in agriculture as the sole source of the hormone was from bovine cadavers. During this time, the knowledge of the structure and function of the hormone increased. WIth the advent of biotechnology, one of the pioneering biotech companies, Genentech succeeded in cloning the gene for BST. Monsanto had working along the same lines and struck a deal with Genentech in 1979 to license Genentech's patents and collaborate on development of a recombinant version of BST – a process on which Monsanto would invest $300 million. The two companies used genetically engineering to clone the rBST gene into E. coli. The bacteria are then grown in bioreactors, then broken up and separated from the rBST, which is purified to produce the injectable hormone. They published their first field trial results in 1982.

Lilly, American Cyanamid, and Upjohn, and Monsanto all submitted applications to market rBST to the FDA, and the FDA completed its review of the human safety component of the these applications in 1986 and found food from rBST-treated cows to be safe; however strong public concern led to calls for more studies, investigations, and public discussions, which included an unprecedented conference on the safety of rBST in 1990 organized by the NIH at the request of Sen. Patrick Leahy. FDA approved Monsanto's application in 1993. Monsanto launched rBST, brand-named Posilac, in 1994.