Biopharming the last two decades emphasis in new drug development has shifted from small-molecule chemicals to large-molecule proteins and other biopharmaceuticals such as human insulin, gene therapies and specialized antibiotic treatments.biopharmaing involves transgenic organisms, particularly plants and animals that have been genetically modified to produce drugs.The process of drug discovery involves the identification of candidates, synthesis, characterization, screening, and assays for therapeutic efficacy.Biopharming (using crops as drug producing bioreactors) offers tremendous economics and health benefits stimulated by improving biotechnology methods. However, these benefits must be weighed against the potential risks to the food supply system and the coast of containing plasma crops to meet zero-tolerance contamination requirements. A combination of strong and adoptable regulatory over sight over technological innovation is required to achieve the twin goals of capturing the benefits of biopharming and safeguarding the food system and the environment. it was also found that the biopharming reduce the cost of pharmaceuticals Recent research developments focus on the fine-tuning of expression systems and the detailed characterization of recombinant products, including the implications of plant-specific glycosylation. This review discusses recent biopharming developments for plant-derived active drug.
Introduction
In this report, we will take a close and critical look at an emerging sector of the biotechnology industry known as biopharming, or the production of pharmaceuticals and biochemicals in plants with the techniques of genetic engineering. While still primarily at the research and development stage, there are reportedly 400 plant-grown drugs in the pipeline, and industry representatives predict an annual market of about $200 billion by 2010 .
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'Biopharming' is an experimental application of biotechnology that involves manipulating the genetic code of plants to induce them to generate substances they do not produce naturally. While the fermentation methods mentioned above entail genetic manipulation of organisms under strictly controlled conditions, biopharming is normally conducted out-of-doors. This is a crucial distinction, because it is impossible to control all of the many factors that influence the growth, health and propagation of plants in the environment. As we shall see, many of the health and environmental concerns surrounding biopharming arise from the inability to force nature to meet the exacting standards demanded in conventional methods of drug production.
Biopharming in present
- Bio-pharming is the production of pharmaceutical proteins in genetically engineered plants.
- Pharmaceuticals can be made in plants at a significantly reduced cost compared to current production methods.
- Major concerns with bio-pharming are that food or feed crops may become contaminated with pharmaceutical products, and that the products may have negative effects on natural ecosystems.
- Bio-pharm crops are regulated by two federal agencies (USDA and FDA) and by state departments of agriculture.
Manufacturing pharmaceutical products in crops has been one of the promised benefits of plant genetic engineering for the past 20 years. This use of biotechnology, sometimes known as “pharming,” “bio-pharming,” or “molecular farming,” has migrated from speculation to the testing phase in fields and greenhouses across the country. Bio-pharming promises more plentiful and cheaper supplies of pharmaceutical drugs, including vaccines for infectious diseases and therapeutic proteins for treatment of such things as cancer and heart disease. “Plant-made pharmaceuticals” (PMPs) are produced by genetically engineering plants to produce specific compounds, generally proteins, which are extracted and purified after harvest. As used here, the terms bio-pharming and PMP do not include naturally occurring plant products or nutritionally enhanced foods.
ADVANTAGE OF BIOPHARMING
- Biopharming, an emerging sector of the biotechnology industry that involves engineering plants with genes that allow them to produce pharmaceutical substances, could provide a cost-effective and abundant source of drugs.
- Biologics, which are fast becoming a significant share of all pharmaceuticals in development, are manufactured today with material grown in mammalian cell cultures (usually Chinese hamster ovary cells) -- a process that can be costly and inefficient. For this reason, alternative production systems are in development, such as biopharming, which could help speed new treatments for a range of conditions to market that are currently unavailable. Engineering food crops, such as corn, to act as pharmaceutical factories may help to fulfill that promise.
- 'Agricultural biotechnology is a powerful tool that continues to stretch the bounds of the imagination,' said Michael Rodemeyer, executive director of the Initiative. 'Scientists can now take food crops like corn and turn them into protein factories for drug production -- a process that promises to transform the way medicines are made. But this power is not without some risk. Therefore, it's important that we find ways to reap the benefits of these products while safeguarding the food supply and the environment. We can't afford any more near-misses.'
Some of the key points that emerged
- Biopharming is promising and moving fast. Though there are not yet any FDA-approved drugs containing material from pharma plants,that a growing interest in developing alternatives to mammalian cells systems has spurred industry to move rapidly toward commercial applications of pharma plants, with a variety of field tests and clinical trials now underway.
- A growing number of cutting-edge treatments for arthritis, herpes, cancer and infectious diseases could be manufactured using biopharming. Manufacturing these drugs today via mammalian cells is very expensive and there is not enough capacity to meet current, not to mention future, needs. For example, there are four pharmaceutical products requiring human antibodies that now consume three-quarters of current fermentation capacity. Some 20 to 50 products in the pipeline could be delayed by lack of manufacturing capacity. Biopharming could solve these issues by not only lowering costs (it is estimated that biopharming could cut costs by one-eighth), but also by allowing companies to rapidly ramp up capacity by merely planting more acreage (as opposed to having to build new manufacturing facilities/plants, which cost $600 million on average and take 5 to 7 years to build).
- Government regulators are trying to keep pace with the technology. The government regulators have instituted requirements for pharma plant cultivation that are more rigorous than those applied to other GM varieties.
- There are questions about regulatory transparency. There is a tension between the desire for public disclosure that would facilitate an independent evaluation of potential health and environmental hazards, and a company's right to protect confidential business information.
- PMPs can be produced at a significantly reduced cost compared to current production methods. Therefore, the technology has the potential to benefit medical patients by providing a more affordable source of vaccines and other pharmaceuticals. However, it is not clear how large the cost reduction will be or how much of the savings will be passed on to consumers.
- Plants can be engineered to produce proteins of greater complexity than is possible with microorganisms, and to produce proteins that cannot be produced in mammalian cell cultures.
BIOPHARMING - a Future Method of Biopharmaceutical Production
Plant molecular farming, or “biopharming”, refers to a new area of science that combines the use of biotechnology and agricultural plants in order to produce valuable products. These may include Plant Made Pharmaceuticals (PMPs), or Plant Made Biologics (PMBs) such as vaccines and human proteins. Plant molecular farming uses the fact that plants have the natural ability to make human and animal proteins. These can be expressed by means of genetic engineering (GE) to induce a transgenic plant to express a specific target protein. This expression can be targeted to a specific plant tissue, facilitating simple harvesting and safe and consistent expression. Potential products include the development of antigens for vaccines that might be mass-produced in plants such as corn and used to fight such diseases as cancer and diabetes.
Conclusion
Biopharming, an emerging sector of the biotechnology industry that involves engineering plants with genes that allow them to produce pharmaceutical substances, could provide a cost-effective and abundant source of drugs.
Bio-pharming promises more plentiful and cheaper supplies of pharmaceutical drugs, including vaccines for infectious diseases and therapeutic proteins for treatment of such things as cancer and heart disease.
PMPs can be produced at a significantly reduced cost compared to current production methods. Therefore, the technology has the potential to benefit medical patients by providing a more affordable source of vaccines and other pharmaceuticals. However, it is not clear how large the cost reduction will be or how much of the savings will be passed on to consumers.
References
- Alan Dove (2000). 'Milking the Genome for Profit'. Nature Biotechnology 18: 1045–1048. doi:10.1038/80231. http://www.nature.com/nbt/journal/v18/n10/full/nbt1000_1045.html.
- Phillip B. C. Jones. 'European Regulators Curdle Plans for Goat Milk Human Antithrombin'. http://www.isb.vt.edu/articles/apr0603.htm. Retrieved on 2006-06-23.
- 'Go-ahead for 'pharmed' goat drug'. http://news.bbc.co.uk/1/hi/sci/tech/5041298.stm. Retrieved on 2006-10-25. Retrieved on 15 May 2007
- Medicago Inc. press release 29 January 2007. Retrieved on 15 May 2007 [|Lamb, Celia] (2006-01-13). 'Large Scale files Ch. 11 after closing'. Sacramento BusinessJournal. http://sacramento.bizjournals.com/sacramento/stories/2006/01/16/story1.html. Retrieved on 2007-05-10.
- Biotech firm puts off rice crop here But company says it plans to sow next year. St. Louis Post-Dispatch. April 29, 2005. Pg. A3.
- Biotech potato provides hepatitis vaccine. The Atlanta Journal-Constitution. February 15, 2005. Pg. 3A.
- Biotechnology Venture Hits Unexpected Snags. New York Times. November 23, 2001. Pg. 5.
- Canadian scientists make insulin from plants: 'Bio-pharming' poised to meet huge diabetes demand at less cost. The Ottawa Citizen. February 27, 2005. Pg. A1.
- GM corn set to stop man spreading his seed. The Observer. September 9, 2001. Pg. 1.
- Pharming plans transgenic first. Financial Times. May 3, 2005. Pg. 18.
- USDA says bio-crop safeguards are tighter ProdiGene is back in Nebraska with test plot. Omaha World Herald. June 2, 2004 Pg. 01D
- Release Permits for Pharmaceuticals, Industrials,Value Added Proteins for Human Consumption,or for Phytoremediation Granted or Pending by APHIS as of March 29, 2006. [1]
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