Pharming (genetics)
Encyclopedia
Pharming is a portmanteau of farming and "pharmaceutical" and refers to the use of genetic engineering
to insert gene
s that code for useful pharmaceuticals into host animals or plants that would otherwise not express those genes. As a consequence, the host animals or plants then make the pharmaceutical product in large quantity, which can then be purified and used as a drug product. Some drug products and nutrients may be able to be delivered directly by eating the plant or drinking the milk. Such technology has the potential to produce large quantities of cheap vaccines, or other important pharmaceutical products such as insulin.
The products of pharming are recombinant proteins or their metabolic products. Drugs made from recombinant
proteins potentially have greater efficacy and fewer side effects than small organic molecules
(which are often screened as potential drugs) because their action can be more precisely targeted toward the cause of a disease rather than treatment of symptoms. Recombinant proteins are most commonly produced using bacteria
or yeast
in a bioreactor
, but pharming offers the advantage to the producer that it does not require expensive infrastructure, and production capacity can be quickly scaled to meet demand. It is estimated that the expense of producing a recombinant protein drug via pharming will be less than 70% of the current cost.
In the United States
, Transgenic plants including but not limited to those that produce pharmaceuticals, are regulated by three government agencies, which comprise the Coordinated Framework for Regulation of Biotechnology
established in 1986.
One approach to this technology is the creation of a transgenic mammal that can produce the biopharmaceutical in its milk (or blood or urine). 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. In February 2009 the US FDA granted marketing approval for the first drug to be produced in genetically modified livestock. The drug is called ATryn
, which is antithrombin protein purified from the milk of genetically-modified goats. Marketing permission was granted by the European Medicines Agency
in August 2006.
industry that involves the process of genetically engineering plants so that they can produce certain types of therapeutically important proteins and associate molecules such as peptides and secondary metabolites. The proteins and molecules can then be harvested and used to produce pharmaceuticals.
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
. The advantage of rice and flax is that they are self-pollinating, and thus gene flow
issues (see below) are avoided. However, human error could still result in pharm crops entering the food supply. Using a minor crop such as safflower or Tobacco, avoids the greater political pressures and risk to the food supply involved with using staple crops such as beans or rice. Despite these risks, corn and soybeans are currently the most common crops used to produce pharmaceuticals.
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. These frugal organisms can be cultivated in photobioreactors, secrete the transformed proteins into the growth medium and, thus, substantially reduce the burden of protein purification
in preparing recombinant proteins for medical use.. 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..
There is much debate over the practicality of using plants to produce proteins. Some groups fear that contamination of conventional crops might occur; in several instances, companies have been fined for violating protocols, resulting in potential contamination. This leads to the question of "Why would biotechnology companies use plants to produce proteins?"
Conventional production methods for pharmaceutical proteins involve substantial investments of both time and finances. Not only are there manufacturing challenges involved with conventional production methods, but there are also considerable regulatory challenges that must be met.
There are currently ~200 protein-based medicines (vaccines, monoclonal antibody drugs, and other therapeutic proteins and peptides) on the market, and ~400 in development. (Statistics are from BIO, the biotechnology trade group) Consequently, companies are motivated to provide a wider range of options for production of proteins used in these treatments.
Biopharm proponents claim that using plants can offer an easily controllable, safe, and cost-effective method for manufacturing proteins, provided that proper regulatory safeguards are put into place to ensure that no outcrossing can occur. It is also important to note, that the global demand for particular pharmaceutical protein can easily be met from just a few acres of pharma-crop, which can be grown under high containment conditions (e.g. in the greenhouse). Some scientists even think that the term "gardening" is more appropriate than farming. Opponents are concerned that there are too many ways in which contamination of the food supply and the environment can occur to make this form of production socially desirable, or even economically feasible.
Compared to conventional production methods, plant-made pharmaceuticals could save substantial time, money, and provide a system for producing proteins that could solve current production challenges.
Although no drugs from pharm crops are currently on the market, open field growing trials of these crops began in the United States in 1992 and have taken place every year since. The United States Department of Agriculture
has approved planting of pharma crops in every state, with most testing taking place in Hawaii, Nebraska, Iowa, and Wisconsin.
These pharmaceutical crops could become extremely beneficial in developing countries. The World Health Organization
estimates that nearly 3 million people die each year from vaccine preventable disease, mostly in Africa. 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.
Companies in this industry hope that proteins made from plants can be used to develop treatments for some of the most serious diseases and conditions such as cancer
, diabetes, HIV
, heart disease
, Alzheimer's disease
, cystic fibrosis
, multiple sclerosis
, Hepatitis
C, and arthritis
, but no such products have as yet been approved.
, potentially dangerous pharmaceuticals may inadvertently enter the food supply. Precedents involving non-pharmaceutical genetically modified crops include the Starlink
controversy, and trade war over genetically modified food between the European union
and the USA. A similar reaction to pharmed rice is feared from Japan
.
In 2002, ProdiGene was fined $250,000 and ordered by the USDA to pay over $3 million in cleanup costs after allowing a fraction of a bushel of volunteer pharm corn to comingle with the soybean crop later planted in that field. Although the chance of gene flow between species is claimed to be low and there was in this case no threat to consumers, the USDA has a zero tolerance policy. ProdiGene has since revised its protocols and resumed operations in Nebraska.
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 has withdrawn its 2006 permit to plant in Missouri due to unrelated circumstances. The company's field trials in North Carolina are expected to continue.
Projects known to be abandoned
Genetic engineering
Genetic engineering, also called genetic modification, is the direct human manipulation of an organism's genome using modern DNA technology. It involves the introduction of foreign DNA or synthetic genes into the organism of interest...
to insert gene
Gene
A gene is a molecular unit of heredity of a living organism. It is a name given to some stretches of DNA and RNA that code for a type of protein or for an RNA chain that has a function in the organism. Living beings depend on genes, as they specify all proteins and functional RNA chains...
s that code for useful pharmaceuticals into host animals or plants that would otherwise not express those genes. As a consequence, the host animals or plants then make the pharmaceutical product in large quantity, which can then be purified and used as a drug product. Some drug products and nutrients may be able to be delivered directly by eating the plant or drinking the milk. Such technology has the potential to produce large quantities of cheap vaccines, or other important pharmaceutical products such as insulin.
The products of pharming are recombinant proteins or their metabolic products. Drugs made from recombinant
Recombinant DNA
Recombinant DNA molecules are DNA sequences that result from the use of laboratory methods to bring together genetic material from multiple sources, creating sequences that would not otherwise be found in biological organisms...
proteins potentially have greater efficacy and fewer side effects than small organic molecules
Small molecule
In the fields of pharmacology and biochemistry, a small molecule is a low molecular weight organic compound which is by definition not a polymer...
(which are often screened as potential drugs) because their action can be more precisely targeted toward the cause of a disease rather than treatment of symptoms. Recombinant proteins are most commonly produced using bacteria
Bacteria
Bacteria are a large domain of prokaryotic microorganisms. Typically a few micrometres in length, bacteria have a wide range of shapes, ranging from spheres to rods and spirals...
or yeast
Yeast
Yeasts are eukaryotic micro-organisms classified in the kingdom Fungi, with 1,500 species currently described estimated to be only 1% of all fungal species. Most reproduce asexually by mitosis, and many do so by an asymmetric division process called budding...
in a bioreactor
Bioreactor
A bioreactor may refer to any manufactured or engineered device or system that supports a biologically active environment. In one case, a bioreactor is a vessel in which a chemical process is carried out which involves organisms or biochemically active substances derived from such organisms. This...
, but pharming offers the advantage to the producer that it does not require expensive infrastructure, and production capacity can be quickly scaled to meet demand. It is estimated that the expense of producing a recombinant protein drug via pharming will be less than 70% of the current cost.
In the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
, Transgenic plants including but not limited to those that produce pharmaceuticals, are regulated by three government agencies, which comprise the Coordinated Framework for Regulation of Biotechnology
Coordinated Framework for Regulation of Biotechnology
The Coordinated Framework for Regulation of Biotechnology, proposed in 1984 by the White House Office of Science and Technology Policy and finalized in 1986, spells out the basic federal policy for regulating the development and introduction of products derived from biotechnology.A key principle of...
established in 1986.
- United States Department of AgricultureUnited States Department of AgricultureThe United States Department of Agriculture is the United States federal executive department responsible for developing and executing U.S. federal government policy on farming, agriculture, and food...
Animal and Plant Health Inspection ServiceAnimal and Plant Health Inspection ServiceAnimal and Plant Health Inspection Service is an agency of the United States Department of Agriculture responsible for protecting animal health, animal welfare, and plant health. APHIS is the lead agency for collaboration with other agencies to protect U.S. agriculture from invasive pests and...
- evaluates potential agricultural impacts such as gene flowGene flowIn population genetics, gene flow is the transfer of alleles of genes from one population to another.Migration into or out of a population may be responsible for a marked change in allele frequencies...
and 'weediness' - United States Environmental Protection Agency - evaluates potential environmental impact intergenic microorganisms under the Toxic Substances Control ActToxic Substances Control ActThe Toxic Substances Control Act is a United States law, passed by the United States Congress in 1976, that regulates the introduction of new or already existing chemicals. It grandfathered most existing chemicals, in contrast to the Registration, Evaluation and Authorization of Chemicals ...
- United States Department of Health and Human ServicesUnited States Department of Health and Human ServicesThe United States Department of Health and Human Services is a Cabinet department of the United States government with the goal of protecting the health of all Americans and providing essential human services. Its motto is "Improving the health, safety, and well-being of America"...
Food and Drug AdministrationFood and Drug AdministrationThe Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA) - evaluates human health risk if the plant or one of its proteins is intended for human consumption
Pharming in mammals
Expression in the milk of a mammal, such as a cow, sheep, or goat, is a common application, as milk production is plentiful and purification from milk is relatively easy. Hamsters and rabbits have also been used in preliminary studies because of their faster breeding.One approach to this technology is the creation of a transgenic mammal that can produce the biopharmaceutical in its milk (or blood or urine). 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. In February 2009 the US FDA granted marketing approval for the first drug to be produced in genetically modified livestock. The drug is called ATryn
ATryn
ATryn is the brand name of the anticoagulant antithrombin manufactured by the Massachusetts-based U.S. company GTC Biotherapeutics. It is made from the milk of goats that have been genetically modified to produce human antithrombin, a plasma protein with anticoagulant properties. Microinjection was...
, which is antithrombin protein purified from the milk of genetically-modified goats. Marketing permission was granted by the European Medicines Agency
European Medicines Agency
The European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
in August 2006.
Pharming in plants
Plant-Made Pharmaceuticals (PMPs), also referred to as Biopharming, is a sub-sector of the biotechnologyBiotechnology
Biotechnology is a field of applied biology that involves the use of living organisms and bioprocesses in engineering, technology, medicine and other fields requiring bioproducts. Biotechnology also utilizes these products for manufacturing purpose...
industry that involves the process of genetically engineering plants so that they can produce certain types of therapeutically important proteins and associate molecules such as peptides and secondary metabolites. The proteins and molecules can then be harvested and used to produce pharmaceuticals.
Arabidopsis
Arabidopsis thaliana
Arabidopsis thaliana is a small flowering plant native to Europe, Asia, and northwestern Africa. A spring annual with a relatively short life cycle, arabidopsis is popular as a model organism in plant biology and genetics...
is often used as a model organism
Model organism
A model organism is a non-human species that is extensively studied to understand particular biological phenomena, with the expectation that discoveries made in the organism model will provide insight into the workings of other organisms. Model organisms are in vivo models and are widely used to...
to study gene expression in plants, while actual production may be carried out in maize
Maize
Maize known in many English-speaking countries as corn or mielie/mealie, is a grain domesticated by indigenous peoples in Mesoamerica in prehistoric times. The leafy stalk produces ears which contain seeds called kernels. Though technically a grain, maize kernels are used in cooking as a vegetable...
, rice
Rice
Rice is the seed of the monocot plants Oryza sativa or Oryza glaberrima . As a cereal grain, it is the most important staple food for a large part of the world's human population, especially in East Asia, Southeast Asia, South Asia, the Middle East, and the West Indies...
, potatoes, tobacco
Tobacco
Tobacco is an agricultural product processed from the leaves of plants in the genus Nicotiana. It can be consumed, used as a pesticide and, in the form of nicotine tartrate, used in some medicines...
, flax
Flax
Flax is a member of the genus Linum in the family Linaceae. It is native to the region extending from the eastern Mediterranean to India and was probably first domesticated in the Fertile Crescent...
or safflower
Safflower
Safflower is a highly branched, herbaceous, thistle-like annual. It is commercially cultivated for vegetable oil extracted from the seeds. Plants are 30 to 150 cm tall with globular flower heads having yellow, orange or red flowers. Each branch will usually have from one to five flower heads...
. The advantage of rice and flax is that they are self-pollinating, and thus gene flow
Gene flow
In population genetics, gene flow is the transfer of alleles of genes from one population to another.Migration into or out of a population may be responsible for a marked change in allele frequencies...
issues (see below) are avoided. However, human error could still result in pharm crops entering the food supply. Using a minor crop such as safflower or Tobacco, avoids the greater political pressures and risk to the food supply involved with using staple crops such as beans or rice. Despite these risks, corn and soybeans are currently the most common crops used to produce pharmaceuticals.
Lemna
Lemna is a genus of free-floating aquatic plants from the duckweed family. These rapidly-growing plants have found uses as a model system for studies in community ecology, basic plant biology, in ecotoxicology, in production of biopharmaceuticals, and as a source of animal feeds for agriculture...
Lemna minor
Lemna minor
Lemna minor is a species of Lemna with a subcosmopolitan distribution, native throughout most of Africa, Asia, Europe and North America, occurring everywhere that freshwater ponds and slow-moving streams occur, except for arctic and subarctic climates...
or the moss
Moss
Mosses are small, soft plants that are typically 1–10 cm tall, though some species are much larger. They commonly grow close together in clumps or mats in damp or shady locations. They do not have flowers or seeds, and their simple leaves cover the thin wiry stems...
Physcomitrella patens
Physcomitrella patens
Physcomitrella patens is a moss used as a model organism for studies on plant evolution, development and physiology.-Model organism:...
have shown to be useful for the production of biopharmaceuticals. These frugal organisms can be cultivated in photobioreactors, secrete the transformed proteins into the growth medium and, thus, substantially reduce the burden of protein purification
Protein purification
Protein purification is a series of processes intended to isolate a single type of protein from a complex mixture. Protein purification is vital for the characterization of the function, structure and interactions of the protein of interest. The starting material is usually a biological tissue or...
in preparing recombinant proteins for medical use.. In addition, both species can be engineered to cause secretion of proteins with human patterns of glycosylation
Glycosylation
Glycosylation is the reaction in which a carbohydrate, i.e. a glycosyl donor, is attached to a hydroxyl or other functional group of another molecule . In biology glycosylation refers to the enzymatic process that attaches glycans to proteins, lipids, or other organic molecules...
, an improvement over conventional plant gene-expression systems..
There is much debate over the practicality of using plants to produce proteins. Some groups fear that contamination of conventional crops might occur; in several instances, companies have been fined for violating protocols, resulting in potential contamination. This leads to the question of "Why would biotechnology companies use plants to produce proteins?"
Conventional production methods for pharmaceutical proteins involve substantial investments of both time and finances. Not only are there manufacturing challenges involved with conventional production methods, but there are also considerable regulatory challenges that must be met.
There are currently ~200 protein-based medicines (vaccines, monoclonal antibody drugs, and other therapeutic proteins and peptides) on the market, and ~400 in development. (Statistics are from BIO, the biotechnology trade group) Consequently, companies are motivated to provide a wider range of options for production of proteins used in these treatments.
Biopharm proponents claim that using plants can offer an easily controllable, safe, and cost-effective method for manufacturing proteins, provided that proper regulatory safeguards are put into place to ensure that no outcrossing can occur. It is also important to note, that the global demand for particular pharmaceutical protein can easily be met from just a few acres of pharma-crop, which can be grown under high containment conditions (e.g. in the greenhouse). Some scientists even think that the term "gardening" is more appropriate than farming. Opponents are concerned that there are too many ways in which contamination of the food supply and the environment can occur to make this form of production socially desirable, or even economically feasible.
Compared to conventional production methods, plant-made pharmaceuticals could save substantial time, money, and provide a system for producing proteins that could solve current production challenges.
Although no drugs from pharm crops are currently on the market, open field growing trials of these crops began in the United States in 1992 and have taken place every year since. The United States Department of Agriculture
United States Department of Agriculture
The United States Department of Agriculture is the United States federal executive department responsible for developing and executing U.S. federal government policy on farming, agriculture, and food...
has approved planting of pharma crops in every state, with most testing taking place in Hawaii, Nebraska, Iowa, and Wisconsin.
These pharmaceutical crops could become extremely beneficial in developing countries. The World Health Organization
World Health Organization
The World Health Organization is a specialized agency of the United Nations that acts as a coordinating authority on international public health. Established on 7 April 1948, with headquarters in Geneva, Switzerland, the agency inherited the mandate and resources of its predecessor, the Health...
estimates that nearly 3 million people die each year from vaccine preventable disease, mostly in Africa. 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.
Companies in this industry hope that proteins made from plants can be used to develop treatments for some of the most serious diseases and conditions such as cancer
Cancer
Cancer , known medically as a malignant neoplasm, is a large group of different diseases, all involving unregulated cell growth. In cancer, cells divide and grow uncontrollably, forming malignant tumors, and invade nearby parts of the body. The cancer may also spread to more distant parts of the...
, diabetes, HIV
HIV
Human immunodeficiency virus is a lentivirus that causes acquired immunodeficiency syndrome , a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive...
, heart disease
Heart disease
Heart disease, cardiac disease or cardiopathy is an umbrella term for a variety of diseases affecting the heart. , it is the leading cause of death in the United States, England, Canada and Wales, accounting for 25.4% of the total deaths in the United States.-Types:-Coronary heart disease:Coronary...
, Alzheimer's disease
Alzheimer's disease
Alzheimer's disease also known in medical literature as Alzheimer disease is the most common form of dementia. There is no cure for the disease, which worsens as it progresses, and eventually leads to death...
, cystic fibrosis
Cystic fibrosis
Cystic fibrosis is a recessive genetic disease affecting most critically the lungs, and also the pancreas, liver, and intestine...
, multiple sclerosis
Multiple sclerosis
Multiple sclerosis is an inflammatory disease in which the fatty myelin sheaths around the axons of the brain and spinal cord are damaged, leading to demyelination and scarring as well as a broad spectrum of signs and symptoms...
, Hepatitis
Hepatitis
Hepatitis is a medical condition defined by the inflammation of the liver and characterized by the presence of inflammatory cells in the tissue of the organ. The name is from the Greek hepar , the root being hepat- , meaning liver, and suffix -itis, meaning "inflammation"...
C, and arthritis
Arthritis
Arthritis is a form of joint disorder that involves inflammation of one or more joints....
, but no such products have as yet been approved.
Controversy over pharming
Those opposed to pharming fear that through either mishandling or gene flowGene flow
In population genetics, gene flow is the transfer of alleles of genes from one population to another.Migration into or out of a population may be responsible for a marked change in allele frequencies...
, potentially dangerous pharmaceuticals may inadvertently enter the food supply. Precedents involving non-pharmaceutical genetically modified crops include the Starlink
Transgenic maize
Genetically modified maize has been deliberately genetically modified to have agronomically desirable traits. Traits that have been engineered into corn include resistance to herbicides and resistance to insect pests, the latter being achieved by incorporation of a gene that codes for the...
controversy, and trade war over genetically modified food between the European union
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
and the USA. A similar reaction to pharmed rice is feared from Japan
Japan
Japan is an island nation in East Asia. Located in the Pacific Ocean, it lies to the east of the Sea of Japan, China, North Korea, South Korea and Russia, stretching from the Sea of Okhotsk in the north to the East China Sea and Taiwan in the south...
.
In 2002, ProdiGene was fined $250,000 and ordered by the USDA to pay over $3 million in cleanup costs after allowing a fraction of a bushel of volunteer pharm corn to comingle with the soybean crop later planted in that field. Although the chance of gene flow between species is claimed to be low and there was in this case no threat to consumers, the USDA has a zero tolerance policy. ProdiGene has since revised its protocols and resumed operations in Nebraska.
In 2005, Anheuser-Busch
Anheuser-Busch
Anheuser-Busch Companies, Inc. , is an American brewing company. The company operates 12 breweries in the United States and 18 in other countries. It was, until December 2009, also one of America's largest theme park operators; operating ten theme parks across the United States through the...
threatened to boycott rice grown in Missouri because of plans by Ventria Bioscience
Ventria Bioscience
Ventria Bioscience is a biotech company with a focus on human nutrition and human therapeutics. The company was established in 1993. The company's core technology is a plant-based protein production system called ExpressTec. Ventria's product pipeline is based on recombinant lactoferrin and...
to grow pharm rice in the state. A compromise was reached, but Ventria has withdrawn its 2006 permit to plant in Missouri due to unrelated circumstances. The company's field trials in North Carolina are expected to continue.
List of originators (companies and universities) and research projects and products
Please note that this list is by no means exhaustive.- Agragen - docosahexaenoic acidDocosahexaenoic acidDocosahexaenoic acid is an omega-3 fatty acid that is a primary structural component of the human brain and retina. In chemical structure, DHA is a carboxylic acid with a 22-carbon chain and six cis double bonds; the first double bond is located at the third carbon from the omega end...
and human serum albuminHuman serum albuminHuman serum albumin is the most abundant protein in human blood plasma. It is produced in the liver. Albumin constitutes about half of the blood serum protein...
in flaxFlaxFlax is a member of the genus Linum in the family Linaceae. It is native to the region extending from the eastern Mediterranean to India and was probably first domesticated in the Fertile Crescent... - Chlorogen, Inc. - choleraCholeraCholera is an infection of the small intestine that is caused by the bacterium Vibrio cholerae. The main symptoms are profuse watery diarrhea and vomiting. Transmission occurs primarily by drinking or eating water or food that has been contaminated by the diarrhea of an infected person or the feces...
, anthraxAnthraxAnthrax is an acute disease caused by the bacterium Bacillus anthracis. Most forms of the disease are lethal, and it affects both humans and other animals...
, and plagueBubonic plaguePlague is a deadly infectious disease that is caused by the enterobacteria Yersinia pestis, named after the French-Swiss bacteriologist Alexandre Yersin. Primarily carried by rodents and spread to humans via fleas, the disease is notorious throughout history, due to the unrivaled scale of death...
vaccineVaccineA vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe or its toxins...
s, albumin, cloriene, interferonInterferonInterferons are proteins made and released by host cells in response to the presence of pathogens—such as viruses, bacteria, or parasites—or tumor cells. They allow communication between cells to trigger the protective defenses of the immune system that eradicate pathogens or tumors.IFNs belong to...
for liver diseases including hepatitis CHepatitis CHepatitis C is an infectious disease primarily affecting the liver, caused by the hepatitis C virus . The infection is often asymptomatic, but chronic infection can lead to scarring of the liver and ultimately to cirrhosis, which is generally apparent after many years...
, elastinElastinElastin is a protein in connective tissue that is elastic and allows many tissues in the body to resume their shape after stretching or contracting. Elastin helps skin to return to its original position when it is poked or pinched. Elastin is also an important load-bearing tissue in the bodies of...
, 4HB, and insulin-like growth factorInsulin-like growth factorThe insulin-like growth factors are proteins with high sequence similarity to insulin. IGFs are part of a complex system that cells use to communicate with their physiologic environment...
in tobaccoTobaccoTobacco is an agricultural product processed from the leaves of plants in the genus Nicotiana. It can be consumed, used as a pesticide and, in the form of nicotine tartrate, used in some medicines...
chloroplasts - Dow AgroSciencesDow AgroSciencesDow AgroSciences LLC is a wholly owned subsidiary of the Dow Chemical Company specializing in not only agricultural chemicals such as pesticides, but also seeds and biotechnology solutions. The company is based in Indianapolis, Indiana, in the United States...
- poultry vaccine against Newcastle disease virus (first PMP to be approved for marketing by the USDA Center for Veterinary Biologics - -however as of 2010 it appears that Dow AgroSciences has not begun marketing the product.) - Dow Chemical CompanyDow Chemical CompanyThe Dow Chemical Company is a multinational corporation headquartered in Midland, Michigan, United States. As of 2007, it is the second largest chemical manufacturer in the world by revenue and as of February 2009, the third-largest chemical company in the world by market capitalization .Dow...
- anti-cancer antibodies - Epicyte - spermicidal antibodies in corn
- GenzymeGenzymeGenzyme Corporation is a fully owned subsidiary of Sanofi-Aventis. Before its acquisition, Genzyme was an American biotechnology company based in Cambridge, Massachusetts. In 2010, Genzyme was the world’s third-largest biotechnology company, employing more than 11,000 people around the world...
- antithrombin III in goat milk - GTC Biotherapeutics - ATrynATrynATryn is the brand name of the anticoagulant antithrombin manufactured by the Massachusetts-based U.S. company GTC Biotherapeutics. It is made from the milk of goats that have been genetically modified to produce human antithrombin, a plasma protein with anticoagulant properties. Microinjection was...
(recombinant human antithrombin) in goat milk - Iowa State UniversityIowa State UniversityIowa State University of Science and Technology, more commonly known as Iowa State University , is a public land-grant and space-grant research university located in Ames, Iowa, United States. Iowa State has produced astronauts, scientists, and Nobel and Pulitzer Prize winners, along with a host of...
- unknown product in corn - MacIntosh & Associates, Inc. - unknown product in peas
- Medicago Inc.Medicago (company)Medicago Inc. Quebec City, Quebec, Canada is a publicly-traded biotechnology company focused on the development, production and commercialization of protein-based biopharmaceuticals by the genetic engineering of plants. Medicago is listed on the Toronto Stock Exchange under the symbol...
- Pre-clinical trials of Influenza vaccine in alfalfaAlfalfaAlfalfa is a flowering plant in the pea family Fabaceae cultivated as an important forage crop in the US, Canada, Argentina, France, Australia, the Middle East, South Africa, and many other countries. It is known as lucerne in the UK, France, Australia, South Africa and New Zealand, and known as... - Meristem Therapeutics - LipaseLipaseA lipase is an enzyme that catalyzes the formation or cleavage of fats . Lipases are a subclass of the esterases.Lipases perform essential roles in the digestion, transport and processing of dietary lipids in most, if not all, living organisms...
, lactoferrinLactoferrinLactoferrin , also known as lactotransferrin , is a multifunctional protein of the transferrin family. Lactoferrin is a globular glycoprotein with a molecular mass of about 80 kDa that is widely represented in various secretory fluids, such as milk, saliva, tears, and nasal secretions...
, plasma proteins, collagenCollagenCollagen is a group of naturally occurring proteins found in animals, especially in the flesh and connective tissues of mammals. It is the main component of connective tissue, and is the most abundant protein in mammals, making up about 25% to 35% of the whole-body protein content...
, antibodies (IgA, IgM), allergens and protease inhibitors in tobacco - Pharming - C1 inhibitor, human collagenCollagenCollagen is a group of naturally occurring proteins found in animals, especially in the flesh and connective tissues of mammals. It is the main component of connective tissue, and is the most abundant protein in mammals, making up about 25% to 35% of the whole-body protein content...
1, fibrinogenFibrinogenFibrinogen is a soluble plasma glycoprotein, synthesised by the liver, that is converted by thrombin into fibrin during blood coagulation. This is achieved through processes in the coagulation cascade that activate the zymogen prothrombin to the serine protease thrombin, which is responsible for...
(with American Red CrossAmerican Red CrossThe American Red Cross , also known as the American National Red Cross, is a volunteer-led, humanitarian organization that provides emergency assistance, disaster relief and education inside the United States. It is the designated U.S...
), and lactoferrinLactoferrinLactoferrin , also known as lactotransferrin , is a multifunctional protein of the transferrin family. Lactoferrin is a globular glycoprotein with a molecular mass of about 80 kDa that is widely represented in various secretory fluids, such as milk, saliva, tears, and nasal secretions...
in cow milk - Planet Biotechnology - antibodies against Streptococcus mutansStreptococcus mutansStreptococcus mutans is a facultatively aerobic, Gram-positive coccus-shaped bacterium commonly found in the human oral cavity and is a significant contributor to tooth decay.The microbe was first described by J Kilian Clarke in 1924.-Introduction:...
, antibodies against doxorubicinDoxorubicinDoxorubicin INN is a drug used in cancer chemotherapy. It is an anthracycline antibiotic, closely related to the natural product daunomycin, and like all anthracyclines, it works by intercalating DNA....
, and ICAM 1Intercellular adhesion moleculeIntercellular adhesion molecules are members of the family of cell adhesion molecules. They include the following:* ICAM-1 * ICAM2* ICAM3* ICAM4* ICAM5...
receptorReceptor (biochemistry)In biochemistry, a receptor is a molecule found on the surface of a cell, which receives specific chemical signals from neighbouring cells or the wider environment within an organism...
in tobacco - PPL Therapeutics - Alpha 1-antitrypsinAlpha 1-antitrypsinAlpha 1-Antitrypsin or α1-antitrypsin is a protease inhibitor belonging to the serpin superfamily. It is generally known as serum trypsin inhibitor. Alpha 1-antitrypsin is also referred to as alpha-1 proteinase inhibitor because it inhibits a wide variety of proteases...
for cystic fibrosisCystic fibrosisCystic fibrosis is a recessive genetic disease affecting most critically the lungs, and also the pancreas, liver, and intestine...
and emphysemaEmphysemaEmphysema is a long-term, progressive disease of the lungs that primarily causes shortness of breath. In people with emphysema, the tissues necessary to support the physical shape and function of the lungs are destroyed. It is included in a group of diseases called chronic obstructive pulmonary...
in sheep milkSheep milkSheep's milk is the milk of domestic sheep. Though not widely drunk in any modern culture, sheep's milk is commonly used to make cultured dairy products. Well-known cheeses made from sheep milk include the Feta of Greece, Roquefort of France, Manchego from Spain, the Pecorino Romano , the Pecorino... - ProdiGene - aprotininAprotininThe drug aprotinin , is the bovine version of the small protein basic pancreatic trypsin inhibitor, or BPTI, which inhibits trypsin and related proteolytic enzymes. Under the trade name Trasylol, aprotinin was used as a medication administered by injection to reduce bleeding during complex surgery,...
, trypsinTrypsinTrypsin is a serine protease found in the digestive system of many vertebrates, where it hydrolyses proteins. Trypsin is produced in the pancreas as the inactive proenzyme trypsinogen. Trypsin cleaves peptide chains mainly at the carboxyl side of the amino acids lysine or arginine, except when...
and a veterinary TGEGastroenteritisGastroenteritis is marked by severe inflammation of the gastrointestinal tract involving both the stomach and small intestine resulting in acute diarrhea and vomiting. It can be transferred by contact with contaminated food and water...
vaccine in corn - SemBioSys - insulinInsulinInsulin is a hormone central to regulating carbohydrate and fat metabolism in the body. Insulin causes cells in the liver, muscle, and fat tissue to take up glucose from the blood, storing it as glycogen in the liver and muscle....
in safflower - SyngentaSyngentaSyngenta AG is a large global Swiss agribusiness company which notably markets seeds and pesticides. Syngenta is involved in biotechnology and genomic research. The company is a leader in crop protection, and ranks third in total sales in the commercial agricultural seeds market. Sales in 2010 were...
- Beta carotene in rice (this is "golden rice 2") - University of ArizonaUniversity of ArizonaThe University of Arizona is a land-grant and space-grant public institution of higher education and research located in Tucson, Arizona, United States. The University of Arizona was the first university in the state of Arizona, founded in 1885...
- Hepatitis CHepatitis CHepatitis C is an infectious disease primarily affecting the liver, caused by the hepatitis C virus . The infection is often asymptomatic, but chronic infection can lead to scarring of the liver and ultimately to cirrhosis, which is generally apparent after many years...
vaccine in potatoes - Ventria BioscienceVentria BioscienceVentria Bioscience is a biotech company with a focus on human nutrition and human therapeutics. The company was established in 1993. The company's core technology is a plant-based protein production system called ExpressTec. Ventria's product pipeline is based on recombinant lactoferrin and...
- lactoferrinLactoferrinLactoferrin , also known as lactotransferrin , is a multifunctional protein of the transferrin family. Lactoferrin is a globular glycoprotein with a molecular mass of about 80 kDa that is widely represented in various secretory fluids, such as milk, saliva, tears, and nasal secretions...
and lysozymeLysozymeLysozyme, also known as muramidase or N-acetylmuramide glycanhydrolase, are glycoside hydrolases, enzymes that damage bacterial cell walls by catalyzing hydrolysis of 1,4-beta-linkages between N-acetylmuramic acid and N-acetyl-D-glucosamine residues in a peptidoglycan and between...
in rice - Washington State UniversityWashington State UniversityWashington State University is a public research university based in Pullman, Washington, in the Palouse region of the Pacific Northwest. Founded in 1890, WSU is the state's original and largest land-grant university...
- lactoferrinLactoferrinLactoferrin , also known as lactotransferrin , is a multifunctional protein of the transferrin family. Lactoferrin is a globular glycoprotein with a molecular mass of about 80 kDa that is widely represented in various secretory fluids, such as milk, saliva, tears, and nasal secretions...
and lysozymeLysozymeLysozyme, also known as muramidase or N-acetylmuramide glycanhydrolase, are glycoside hydrolases, enzymes that damage bacterial cell walls by catalyzing hydrolysis of 1,4-beta-linkages between N-acetylmuramic acid and N-acetyl-D-glucosamine residues in a peptidoglycan and between...
in barley
Projects known to be abandoned
- Large Scale Biology (bankrupt) - using Tobacco mosaic virusTobacco mosaic virusTobacco mosaic virus is a positive-sense single stranded RNA virus that infects plants, especially tobacco and other members of the family Solanaceae. The infection causes characteristic patterns on the leaves . TMV was the first virus to be discovered...
to develop patient-specific vaccines for Non-Hodgkin's lymphoma, PapillomavirusPapillomavirusPapillomaviridae is an ancient taxonomic family of non-enveloped DNA viruses, collectively known as papillomaviruses. Several hundred species of papillomaviruses, traditionally referred to as "types", have been identified infecting all carefully inspected birds and mammals, but also a small number...
vaccine, parvovirusParvovirusParvovirus, often truncated to "parvo", is both the common name in English casually applied to all the viruses in the Parvoviridae taxonomic family, and also the taxonomic name of the Parvovirus genus within the Parvoviridae family...
vaccine, alpha galactosidase for Fabry disease, lysosomal acid lipase, aprotininAprotininThe drug aprotinin , is the bovine version of the small protein basic pancreatic trypsin inhibitor, or BPTI, which inhibits trypsin and related proteolytic enzymes. Under the trade name Trasylol, aprotinin was used as a medication administered by injection to reduce bleeding during complex surgery,...
, interferonInterferonInterferons are proteins made and released by host cells in response to the presence of pathogens—such as viruses, bacteria, or parasites—or tumor cells. They allow communication between cells to trigger the protective defenses of the immune system that eradicate pathogens or tumors.IFNs belong to...
Alpha 2a and 2b, G-CSF, and Hepatitis B vaccine antigens in tobacco - Monsanto Company - abandoned development of pharmaceutical producing corn
See also
- BiopharmaceuticalBiopharmaceuticalBiopharmaceuticals are medical drugs produced using biotechnology. They include proteins , nucleic acids and living microorganisms like virus and bacteria where the virulence of viruses and bacteria is reduced by the process of attenuation, they can be used for therapeutic or in vivo diagnostic...
- BioremediationBioremediationBioremediation is the use of microorganism metabolism to remove pollutants. Technologies can be generally classified as in situ or ex situ. In situ bioremediation involves treating the contaminated material at the site, while ex situ involves the removal of the contaminated material to be treated...
- Genetically modified organismGenetically modified organismA genetically modified organism or genetically engineered organism is an organism whose genetic material has been altered using genetic engineering techniques. These techniques, generally known as recombinant DNA technology, use DNA molecules from different sources, which are combined into one...
- Polly and MollyPolly and MollyPolly and Molly , two ewes, were the first mammals to have been successfully cloned from an adult somatic cell and to be transgenic animals at the same time. This is not to be confused with Dolly the Sheep which was the first animal to be successfully cloned from an adult somatic cell where there...
- International Center for Technology AssessmentInternational Center for Technology AssessmentThe International Center for Technology Assessment is a U.S. non-profit bi-partisan organization, based in Washington, D.C.. ICTA aims to provide the public with full assessments and analyses of technological impacts on society...
External links
- Pharming for Farmaceuticals
- PHARMING THE FIELD: A Look at the Benefits and Risks of Bioengineering Plants to Produce Pharmaceuticals
- USDA-APHIS Biotechnology Regulatory Services
- EPA Biotechnology page
- FDA Biotechnology page
- Homepage of the Coordinated Framework for Regulation of Biotechnology
- Draft Guidance for APHIS Permits for Field Testing or Movement of Organisms with Pharmaceutical or Industrial Intent
- PlantPharma.org Online Community
- National Science Foundation
- Pharma-Planta Consortium
- Biotechnology Industry Organization
- Biopharmaceuticals.com
- Society for Moleculture, a non-for-profit organisation for plant- factories, Québec, Canada
- PharmCrops