Biotechnology Club

Each year the average American spends thousands of dollars on medicine.  And each year consumers, farmers, and businesses look for new ways which they have the possibility to save a little more of their hard earned money.  This year has been no exception, with the United States economic recession it is becoming more and more important that everyone to find a way to make ends meet.  Plant made Pharmaceuticals could very well provide a solution for the thousands of dollars spent each year for prescription drugs.  Let us show you how Iowans could benefit from PMPs.

The Disadvantages of Traditional Methods

Pharmaceutical companies spend millions on creating pharmaceutical compounds to make medicine. In order to produce the medicine many people take each day a pharmaceutical company usually purchases fermentors and bioreactors. By using fermentors and bioreactors, high-quality pharmaceutical components can be created quickly.

Although this has produced many high quality pharmaceuticals in the past, there are a few drawbacks to this process:

1. It generally takes three to seven years to build and establish a functional bioreactor to generate the pharmaceuticals.
2. The bioreactors cost $450-$600 million dollars.
3. Their capacity has become severely limited. In 2002 just four pharmaceutical components required 75% of the global bioreactor capacity; by the end of the decade they are anticipating more than 80 different pharmaceutical components will be generated.

This process is not only time consuming and expensive to start creating pharmaceuticals, but by the time the products are created the cost to the consumer has gone up as well to make up for these large expenditures, the average cost of pharmaceuticals produced from fermentation is $50-$100 per gram; and the cost for pharmaceuticals components generated by a bioreactor cost $105-$175 per gram.

How Iowa Farmers & Consumers benefit from PMPs?

With the rising product costs and the diminishing economy many consumers are looking for ways to save money and are trying to find new ways to make products in a less expensive manner. And plant made pharmaceuticals may just be the answer many are looking for. Plant made pharmaceuticals, or PMPs, are created by genetically engineering a plants so that it produces a desired pharmaceutical component within it. The pharmaceutical component can then be extracted and used to create the medicine on the market today. A 2003 report has estimated the cost to produce a PMP is only $12-$15 per gram. That is up to $82 cheaper than fermented pharmaceuticals and $163 cheaper than bioreactor generated pharmaceuticals per gram.

In addition to the direct cost to generate a pharmaceutical component, there are many other advantages to using PMPs instead of traditionally made pharmaceuticals. PMPs have been shown to produce high yields of pharmaceutical components. In July 2006, Calgary-based SemBioSys announced that it could produce over one kilogram of insulin per acre of PMP safflower. This is enough insulin to supply 2,500 patients for an entire year. With insulin demand projected to be 16,000 kilograms per year by 2012, SemBioSys’ GM safflower provides a way to supply insulin to a growing diabetic patient population. It is claimed that producing insulin in PMP safflower can reduce capital costs by 70 percent and product costs by 40 percent, compared to existing insulin manufacturing. In February 2007, the USDA announced a preliminary decision to allow SemBioSys to plant 1000 acres of PMP safflower in Washington State.

By increasing the amount of pharmaceuticals that can be generated hundreds of thousands of lives could possibly be saved. PMPs could reduce the duration of childhood diarrhea by 4 million days annually in the United States and allow children to return to school quicker and in turn help parent to return to work faster as well. This alone could generate an economic impact of $1.6 billion dollars in a five year time period.

In 2007, Ventria projected 30,000 acres of PMP rice production per year in Kansas upon full scale commercialization. Assuming this speculative acreage forecast is correct, with an average farm size of approximately 700 acres in Kansas, 43 farmers would possibly benefit from PMP rice production. Ventria estimates $150 to $600 in additional returns per acre relative to corn, PMP rice may bring Kansas farmers an additional $4.5 to $18 million per year, 50 new people would be employed in Ventria’s proposed PMP rice processing facility in Kansas and perhaps 150 additional jobs would be supported in the state of Kansas. Ventria also estimates that $45 million dollars annually in economic impact would be generated by PMP rice production activities in Kansas. (5)

PMPs are High Value/Low Volume

There are many people, farmers especially, that may be concerned about the amount of land that would be taken up by plant made pharmaceuticals.  But, in terms of the land that is utilized for the production of plant made pharmaceuticals, recent statistics show that the total amount of land used to plant pharmcrops over the last ten years is 800 acres. Based on this fact, it is assumed that for the production of 40 plant-made pharmaceuticals, worth $1 billion each, about 40,000 acres of land will be utilized out of the 470 million acres of arable land.  Currently there are more than 11.7 million acres of corn being farmed in Iowa, and there is still more than that available to be farmed.  This means that the amount of land needed to produce PMPs is less than 0.4% of what is currently being farmed.  An amount this little would have virtually no effects on the current food prices, so it is not necessary to worry about land competition with food products at this time.

 How do we prevent cross contamination of food?

There are various reasons why specific regulations are needed for PMPs. PMP crops are designed to maximize the yield of the target protein, which consequently can accumulate up to 5000 times the level typically found for transgene products in crops that are designed for use as food or feed. PMP crops can also undergo multiple genetic modifications (i.e. stacking) to co-introduce pest resistance, molecular confinement, changes in glycosylation, and identity preservation traits. These multiple modifications can also increase the likelihood of unintended effects on the plant. Furthermore, the pharmaceutically active products are designed to elicit a physiological response in humans, and so inadvertently exposing humans or animals to such plant material is generally perceived as a greater concern than the corresponding risk associated with transgenic food crops.

However, the presence of PMPs in food is probably much less likely than contamination with GM food crops, partly because PMP crops will be restricted to relatively small plots of land. For example, nearly 15 000 acres of PMP safflower could deliver the entire predicted global demand for insulin in 2012. The absence of a trade in seeds and viable plants, along with maintaining strictly separated processing streams, should further reduce the risk of food chain contamination.

Key elements of proposed regulations and guidance include dedicated machineries and facilities, contract farming, standard operating procedures for many steps of on-farm work, and training programmes for workers. The higher value and lower acreages associated with pharmaceutical crops could make extensive and redundant confinement measures economically feasible. Emerging regulations focus on extensive physical and organizational confinement measures to avoid outcrossing, spillage of seeds or biomass, and co-mingling with food/feed crops.  More governmental regulations can be found on the APHIS and FDA website.  Links are provided below.

The current PMP pipeline indicates that products from contained systems are on a faster track towards commercialization than PMPs from open-field sites. This partly reflects the perception that contained PMP production attracts a lower regulatory burden, but it might also in some cases reflect the choice of product. For example, high-margin, low-volume products will benefit from contained production, but there will be greater pressure for open-field production in the case of PMPs that give rise to lower-margin, high-volume products, such as nutraceuticals.

References

• http://www.nationalaglawcenter.org/assets/crs/RS21418.pdf
• http://www.dddmag.com/plant-made-pharmaceuticals.aspx
• http://biopharminternational.findpharma.com/biopharm/data/articlestandard//biopharm/172003/54511/article.pdf
• www.rafiusa.org/docs/pmpstudy.pdf 
• http://www.reason.com/news/show/116482.html
• http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6TCW-4T44GKV2&_user=724663&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000040479&_version=1&_urlVersion=0&_userid=724663&md5=6b77116148a667a67a2ba7cba9f2a087