Modern biotechnology has resulted in a resurgence of interest in the production of new therapeutic agents using botanical sources. With nearly biotechnology products approved or in development globally, and with production capacity limited, the need for efficient means of therapeutic protein production is apparent. Through genetic engineering, plants can now be used to produce pharmacologically active proteins, including mammalian antibodies, blood product substitutes, vaccines, hormones, cytokines, and a variety of other therapeutic agents.
Efficient biopharmaceutical production in plants involves the proper selection of host plant and gene expression system, including a decision as to whether a food crop or a non-food crop is more appropriate. Product safety issues relevant to patients, pharmaceutical workers, and the general public must be addressed, and proper regulation and regulatory oversight must be in place prior to commercial plant-based biopharmaceutical production.
Plant production of pharmaceuticals holds great potential, and may become an important production system for a variety of new biopharmaceutical products. The use of plants or their extracts for the treatment of human disease predates the earliest stages of recorded civilization, dating back at least to the Neanderthal period.
Even today, about one-fourth of current prescription drugs have a botanical origin. Modern biotechnology has led to a resurgence of interest in obtaining new medicinal agents from botanical sources. Through genetic engineering GEplants can now be used to produce a variety of proteins, including mammalian antibodies, blood substitutes, vaccines and other therapeutic entities. GE plants, acting as bioreactors, can efficiently produce recombinant proteins in larger quantities than those produced using mammalian cell systems.
Large quantities of biomass can be easily grown in the field, and may permit storage of material prior to processing. Thus, plants offer the potential for efficient, large-scale production of recombinant proteins with increased freedom from contaminating human pathogens. During the last two decades, approximately 95 biopharmaceutical products have been approved by one or more regulatory agencies for the treatment of various human diseases including diabetes mellitus, growth disorders, neurological and genetic maladies, inflammatory conditions, and blood dyscrasias.
This rapid increase in the number of new protein and peptide drugs reflects rapid advances in molecular biology, highlighted by the success of the human genome project that, in turn, will help to identify many additional opportunities for therapeutic intervention.
Unfortunately, our capacity to produce these proteins in the quantities needed is expected to fall far short of demand by the end of the current decade. Number of biopharmaceuticals under development, by disease class as of Number of biopharmaceuticals under development, by type of agent. Advances in plant biotechnology have already resulted in plants that produce monoclonal antibodies or other therapeutic proteins, or that may serve as a source of edible vaccines.
Research now underway will almost certainly result in GE plants designed to produce other therapeutic agents including hormones e. These proteins or peptides possess therapeutic value themselves, have properties that allow them to be used as precursors in the synthesis of medicinal compounds, or may serve as technical enzymes in pharmaceutical production. This review will attempt to catalogue the potential therapeutic applications of plant biotechnology and to address concerns related to the safety and efficacy of these agents in relation to human health and to specific disease states.
Plant biotechnology can lead to the commercial production of pharmacologically important proteins which are, in many cases, fully functional and nearly identical to their mammalian counterparts. Comparison of recombinant protein production in plants, yeast and mammalian systems.
Biopharmaceutical production in plants necessitates a series of careful decisions regarding three critical areas: i the gene expression system to be used, ii the location of gene expression within the plant, and iii the type of plant to be used.
There are a number of gene expression strategies that can be used to produce specific proteins in plants. With transient expression TEa gene sequence is inserted into plant cells using plant viruses, ballistic gene-gunor other methods, without incorporation of the new genetic material into the plant chromosome.
TE systems can be rapidly deployed and can produce large amounts of protein, 2 but because non-chromosomal DNA is not copied with the process of mitosis or meiosis, gene expression is neither permanent nor heritable. While TE systems are very useful for research and development, and may be useful for drug production, they require the fresh production of transformed plants with each planting and may be less attractive for long-term or high-volume protein production.
Alternatively, the primary plant chromosome can be altered to allow for the permanent and heritable expression of a particular protein, i. This can be done using Agrobacterium tumefaciensa pathogen of plants that, in nature, transfers genetic material to the plant chromosome. By modifying the genetic content of Agrobacteriumdesired genes can be readily inserted into many kinds of plants, especially dicots such as soybean. While permanent modification of the plant genome is more costly and time-consuming, it offers the clear advantage of stable, ongoing protein production with repeated planting alone.
Finally, systems exist that modify chloroplast DNA in plants and that can lead to heritable changes in protein expression. These tiny energy-producing organelles appear to possess advantages over nuclear transformation, particularly given that each cell may carry hundreds or thousands of such organelles, resulting in the ability to sustain very high numbers of functional gene copies. Consideration must also be given to where within the plant a pharmaceutical protein is to be produced.
Current technology allows gene expression and protein production in either the green matter of the plant whole plant expression or selectively in the seed or other tissues through the use of selective promoter systems. Tuber or root production, while feasible, shares many of the characteristics of green matter production systems.
Unlike green matter, seeds generally contain fewer phenolic compounds and a less complex mixture of proteins and have specifically evolved to provide for stable, long-term storage of proteins and other materials in order to assure successful, delayed germination.Pharminga portmanteau of "farming" and " pharmaceutical ", refers to the use of genetic engineering to insert genes that code for useful pharmaceuticals into host animals or plants that would otherwise not express those genes, thus creating a genetically modified organism GMO.
The products of pharming are recombinant proteins or their metabolic products. Recombinant proteins are most commonly produced using bacteria or yeast in a bioreactorbut pharming offers the advantage to the producer that it does not require expensive infrastructure, and production capacity can be quickly scaled to meet demand, at greatly reduced cost.
The first recombinant plant-derived protein PDP was human serum albumininitially produced in in transgenic tobacco and potato plants. 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 s, the pharming industry was robust. Proof of concept has been established for the production of many therapeutic proteinsincluding antibodiesblood productscytokinesgrowth factorshormonesrecombinant enzymes and human and veterinary vaccines.
However, in latejust as ProdiGene was ramping up production of trypsin for commercial launch  it was discovered that volunteer plants left over from the prior harvest of one of their GM corn products were harvested with the conventional soybean crop later planted in that field.
This raised a furor and set the pharming field back, dramatically. 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. In Dow AgroSciences received USDA approval to market a vaccine for poultry against Newcastle diseaseproduced in plant cell culture — the first plant-produced vaccine approved in the U.
Milk is presently the most mature system to produce recombinant proteins from transgenic organisms.
Blood, egg white, seminal plasmaand urine are other theoretically possible systems, but all have drawbacks. Blood, for instance, as of cannot store high levels of stable recombinant proteins, and biologically active proteins in blood may alter the health of the animals.
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.
Marketing permission was granted by the European Medicines Agency in August As indicated above, some mammals typically used for food production such as goats, sheep, pigs, and cows have been modified to produce non-food products, a practice sometimes called pharming. The patentability of such biopharmaceuticals and their process of manufacture is uncertain. Probably, the biopharmaceuticals themselves so made are unpatentable, assuming that they are chemically identical to the preexisting drugs that they imitate.
Several 19th century United States Supreme Court decisions hold that a previously known natural product manufactured by artificial means cannot be patented. On the other hand, it has been suggested that the recent Supreme Court decision in Mayo v. Prometheus  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.
This issue has not yet been decided in the courts. Plant-made pharmaceuticals PMPsalso 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.
Safety of foods derived from genetically modified plants
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 maizericepotatoestobaccoflax or safflower.
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.
Expression of proteins in plant cell or hairy root cultures also minimizes risk of gene transfer, but at a higher cost of production. Sterile hybrids may also be used for the bioconfinement of transgenic plants, although stable lines can't be established.
This characteristic makes them an appealing target for the production of edible vaccinesas viral coat proteins stored in grains do not require cold storage the way many vaccines currently do. Maintaining a temperature controlled supply chain of vaccines is often difficult when delivering vaccines to developing countries. Most commonly, plant transformation is carried out using Agrobacterium tumefaciens.
The protein of interest is often expressed under the control of the cauliflower mosaic virus 35S promoter CaMV35Sa powerful constitutive promoter for driving expression in plants.How Does Science Work? Leslie M. Shama and Robert K. Peterson Agricultural and Biological Risk Assessment, Montana State University, Bozeman, MT Protein-based pharmaceuticals traditionally used for the treatment of disease have been made through the expression of protein in bacterial, fungal, and mammalian cell cultures.
Recently, the possibility to produce more diverse and complex pharmaceutical proteins in plants has reached the laboratory benches of scientists and companies worldwide. These pharmaceuticals are known as plant-made or plant-based pharmaceuticals.
In this article, we will discuss pharmaceutical proteins, how genetic engineering makes it possible to produce proteins in plants, why plants are desirable for the production of pharmaceutical proteins, and which plant systems are being considered for their production. Additionally, we will discuss risk and regulatory issues associated with this new technology.
Proteins are essential to all living organisms for function, structure, and regulation of the body. Proteins are made up of amino acids that are arranged in different combinations and lengths. The differences in arrangements and lengths of amino acids determine the function of the protein. Some examples of proteins include hormones, enzymes, and antibodies. Many people suffer from infectious, inflammatory, and cardiovascular diseases — and these numbers are growing.
Protein-based drugs are the fastest growing class of drugs for the treatment of these diseases in humans and other diseases in animals. The reasons for this are because the numbers of people with diseases such as diabetes are growing and new technologies are making proteins easier to produce. The current methods of production of proteins for pharmaceutical application mammalian, bacterial, and fungal cell cultures are predicted to fall short of demand in the near future Rogers Insulin was the first pharmaceutical protein produced using genetically engineered bacteria Thomas et al.
Insulin originally was isolated from cows and pigs that were slaughtered for food. This method was inefficient and caused some patients to develop allergies from the animal-derived insulin.Letsfit luggage scale manual
Today it is made from the human gene that codes for the insulin protein and is expressed and cloned in the bacterium, Escherichia coli. Large quantities of E. Genetic engineering also has made it possible to use plants as factories for pharmaceutical protein production. Plant-made pharmaceuticals are made by inserting a segment of DNA that encodes the protein of choice into plant cells. The plants or plant cells are essentially factories used to produce the desired proteins and are only grown for the purpose of pharmaceutical applications.
There are two common methods of transformation the process by which DNA from one organism is incorporated into the DNA of another organism that have been established through biotechnology to produce transgenic plants, which, in turn, could be used to create the plants used to make pharmaceutical proteins. The transformation techniques include the Agrobacterium tumefaciens -mediated transformation system and biolistics, also called particle bombardment.
Agrobacterium tumefaciens is a bacterium that naturally infects plants and causes crown gall disease. It is very useful for the production of transgenic plants because it has the amazing ability to transfer a segment of its DNA, called T-DNA, into the nucleus of the plant cells.
Scientists have used A. Crown gall disease does not occur in the plant after being transformed by A. Biolistics, or the Particle Bombardment Transformation System, employs the use of metal particles either of gold or tungsten.
The metal particles are coated with the DNA that is to be transferred into the plant cells. Using a pressurized system, a plastic bullet coated with metal and DNA particles is released from the biolistics machine when the pressure is released.10 Most BIZARRE Genetically Modified Plants EVER
The bullet is shot, and within seconds, stopped by a shield causing the metal coated DNA particles to be knocked off the bullet. The particles are then ultimately forced to be inserted into the plant cells below. Once the genes have been transferred into the cells, the cells expressing the gene of interest must be selected.Plants have considerable potential for the production of biopharmaceutical proteins and peptides because they are easily transformed and provide a cheap source of protein.
Several biotechnology companies are now actively developing, field testing, and patenting plant expression systems, while clinical trials are proceeding on the first biopharmaceuticals derived from them. One transgenic plant-derived biopharmaceutical, hirudin, is now being commercially produced in Canada for the first time.
Biopharmaceuticals derived from genetically modified plants.
Product purification is potentially an expensive process, and various methods are currently being developed to overcome this problem, including oleosin-fusion technology, which allows extraction with oil bodies. In some cases, delivery of a biopharmaceutical product by direct ingestion of the modified plant potentially removes the need for purification. Such biopharmaceuticals and edible vaccines can be stored and distributed as seeds, tubers, or fruits, making immunization programs in developing countries cheaper and potentially easier to administer.
Some of the most expensive biopharmaceuticals of restricted availability, such as glucocerebrosidase, could become much cheaper and more plentiful through production in transgenic plants. Abstract Plants have considerable potential for the production of biopharmaceutical proteins and peptides because they are easily transformed and provide a cheap source of protein.
Publication types Research Support, Non-U. Gov't Review.Skip to search form Skip to main content You are currently offline. Some features of the site may not work correctly. DOI: Goldstein and J. GoldsteinJ.
Modern biotechnology has resulted in a resurgence of interest in the production of new therapeutic agents using botanical sources. With nearly biotechnology products approved or in development globally, and with production capacity limited, the need for efficient means of therapeutic protein production is apparent.
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Publication Type. More Filters. Pharming and transgenic plants. View 1 excerpt, cites background. Research Feed. Plant-Produced Biopharmaceuticals. Biosafety considerations associated with molecular farming in genetically modified plants. View 2 excerpts, cites background. From Neanderthal to nanobiotech: from plant potions to pharming with plant factories.
Plants as animals alternatives in the production of antibodies and other therapeutic agents. Transgenic plants as factories for biopharmaceuticals. Molecular farming of pharmaceutical proteins.The present book contains the findings of an interdisciplinary research project that has addressed a large range of questions associated with pharming: An analysis of the state-of-the-art of plant pharming and animal pharming technologies is followed by an assessment of environmental risks related to pharming and welfare risks for pharming animals.
Public views and attitudes to pharming are investigated on the basis of a comprehensive survey in 15 countries. Moreover, ethical and legal questions, posed by present and foreseeable future practices of pharming, are analysed.
Account Options Sign in. Top charts. New arrivals. Recent scientific advances have made it possible to produce biopharmaceuticals in genetically modified plants and animals, such as maize, tobacco, goats, and chickens. This new branch of biotechnology is termed pharming, composed of the terms pharmaceuticals and farming.
Pharming constitutes an overlap of red and green biotechnology. It offers the prospect of a quicker, cheaper, and more flexible production of biopharmaceuticals compared with current production processes. This is a promising perspective in light of the rapidly growing market of biopharmaceuticals, although the economic competitiveness of pharming remains to be proven. Besides possible benefits for producers, patients and health care systems, pharming also raises a number of complex ecological, social, moral and legal questions that have as yet not been thoroughly discussed.
Reviews Review policy and info. Published on. Flowing text, Original pages. Best for. Web, Tablet, Phone, eReader. Content protection. Flag as inappropriate. It syncs automatically with your account and allows you to read online or offline wherever you are. Please follow the detailed Help center instructions to transfer the files to supported eReaders.Biopharmaceuticals have been available for clinical use for nearly three decades, but foods derived from agribiotechnology have been available for just under a decade.
Controversy surrounding foods from genetically modified GM plants has focused primarily upon their allergenicity, with lesser concerns about antibiotic resistance genes. Concerns are related to possible environmental impacts on non-human species, including effects on non-target species e.Thiele tee broken silber 500g
Further, the use of antibiotics in the development of GM plants does not pose a significant risk to the human population. Foods from the current GM plant products have been shown not to pose any detrimental effects to humans, and, in fact, nutritionally enhanced products are being developed. GM foods are subjected globally to intense regulatory scrutiny, and extensive data have been provided consistently to regulatory agencies in the United States on a voluntary basis, with mandatory reporting of data soon to be in force.
Existing environmental concerns appear to be unjustified on the basis of existing data and experience. Abstract Biopharmaceuticals have been available for clinical use for nearly three decades, but foods derived from agribiotechnology have been available for just under a decade.
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