[5] The first recombinant plant-derived protein (PDP) was human serum albumin, initially produced in 1990 in transgenic tobacco and potato plants.
The industry has slowly recovered, by focusing on pharming in simple plants grown in bioreactors and on growing GM crops in greenhouses.
Once an animal is produced, typically using the pronuclear microinjection method, it becomes efficacious to use cloning technology to create additional offspring that carry the favorable modified genome.
Use of genetically modified goats has been approved by the FDA and EMA to produce ATryn, i.e. recombinant antithrombin, an anticoagulant protein drug.
Several 19th century United States Supreme Court decisions hold that a previously known natural product manufactured by artificial means cannot be patented.
[22] On the other hand, it has been suggested that the recent Supreme Court decision in Mayo v. Prometheus[23] may create a problem in that, in accordance with the ruling in that case, "it may be said that such and such genes manufacture this protein in the same way they always did in a mammal, they produce the same product, and the genetic modification technology used is conventional, so that the steps of the process 'add nothing to the laws of nature that is not already present.
Plant-made pharmaceuticals (PMPs), also referred to as pharming, is a sub-sector of the biotechnology industry that involves the process of genetically engineering plants so that they can produce certain types of therapeutically important proteins and associated molecules such as peptides and secondary metabolites.
[25] Arabidopsis is often used as a model organism to study gene expression in plants, while actual production may be carried out in maize, rice, potatoes, tobacco, flax or safflower.
[26] Tobacco has been a highly popular choice of organism for the expression of transgenes, as it is easily transformed, produces abundant tissues, and survives well in vitro and in greenhouses.
Expression of proteins in plant cell or hairy root cultures also minimizes risk of gene transfer, but at a higher cost of production.
[28] Grain crops are sometimes chosen for pharming because protein products targeted to the endosperm of cereals have been shown to have high heat stability.
[31][32] Recently, the inclusion of antisense genes in expression cassettes has been shown to have potential for improving the plant pharming process.
[33] Recently, several non-crop plants such as the duckweed Lemna minor or the moss Physcomitrella patens have shown to be useful for the production of biopharmaceuticals.
[34][35][36] In addition, both species can be engineered to cause secretion of proteins with human patterns of glycosylation, an improvement over conventional plant gene-expression systems.
[citation needed] Additionally, an Israeli company, Protalix, has developed a method to produce therapeutics in cultured transgenic carrot or tobacco cells.
[39] Protalix and its partner, Pfizer, received FDA approval to market its drug, taliglucerase alfa (Elelyso), as a treatment for Gaucher's disease, in 2012.
Diseases such as measles and hepatitis lead to deaths in countries where the people cannot afford the high costs of vaccines, but pharm crops could help solve this problem.
Other GM foods in development, such as fruits designed to ripen faster or grow larger, are believed not to affect humans any differently from non-GM varieties.
According to the Canadian Food Inspection Agency, in a recent report, says that U.S. demand alone for biotech pharmaceuticals is expanding at 13 percent annually and to reach a market value of $28.6 billion in 2004.