History
The first recombinant plant-derived protein (PDP) was human serum albumin, initially produced in 1990 in transgenic tobacco and potato plants. Open field growing trials of these crops began in the United States in 1992 and have taken place every year since. While the United States Department of Agriculture has approved planting of pharma crops in every state, most testing has taken place in Hawaii, Nebraska, Iowa, and Wisconsin.
In the early 2000s, the pharming industry was robust. Proof of concept has been established for the production of many therapeutic proteins, including antibodies, blood products, cytokines, growth factors, hormones, recombinant enzymes and human and veterinary vaccines. By 2003 several PDP products for the treatment of human diseases were under development by nearly 200 biotech companies, including recombinant gastric lipase for the treatment of cystic fibrosis, and antibodies for the prevention of dental caries and the treatment of non-Hodgkin's lymphoma.
Several proteins were brought to market as research and bioproduction reagents, mostly by Sigma-Aldrich. ProdiGene struck agreements with Sigma to distribute ProdiGene's corn-produced aprotinin, trypsin, beta-glucuronidase (GUS), and avidin. Large Scale Biology and SIgma agreed that Sigma would distribute LSBC's tobacco-produced aprotinin. Sigma also agreed to distribute Ventria's rise-produced Lactoferrin and Lysozyme.
However in late 2002, just as ProdiGene was ramping up production of trypsin for commercial launch it was discovered that volunteer plants (leftover from the prior harvest) of one of their GM corn products were harvested with the conventional soybean crop later planted in that field. ProdiGene was fined $250,000 and ordered by the USDA to pay over $3 million in cleanup costs. This raised a furor and set the pharming field back, dramatically. Many companies went bankrupt as companies faced difficulties getting permits for field trials and investors fled. In reaction, APHIS introduced more strict regulations for pharming field trials in the US in 2003. In 2005, Anheuser-Busch threatened to boycott rice grown in Missouri because of plans by Ventria Bioscience to grow pharm rice in the state. A compromise was reached, but Ventria withdrew its permit to plant in Missouri due to unrelated circumstances.
The industry has slowly recovered, by focusing on pharming in simple plants grown in bioreactors and on growing GM crops in greenhouses. Some companies and academic groups have continued with open-field trials of GM crops that produce drugs. In 2006 Dow AgroSciences received FDA approval to market a vaccine for poultry against Newcastle disease, produced in plant cell culture - the first plant-produced vaccine approved by the FDA and USDA.
Read more about this topic: Pharming (genetics)
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