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European Biopharmaceutical Review

Natural Potential

Agricultural biotechnology offers new platforms which are ushering in the next generation of medicines, foods and fuels. These go beyond providing basic needs to presenting scientifically-based, cost-effective solutions to the most pressing challenges facing the world.

From the beginning of time, animal and plant breeding and fermentation methods contributed to people’s health and well being as well as forming the base of their local economies. Over the centuries, these basic techniques of biotechnology have proliferated. The Food and Agriculture Organization of the UN lists numerous biotechnological advancements employed in the development of biotech crops and the application of biotechnology to farming and food safety, such as fermentation, mutagenesis, micropropagation, hybridisation and recombinant gene technologies, and analytical methods of testing such as PCR. All of these techniques play a comparable role in the development of new bioenergy sources, as well as the most recent evolution of agricultural biotechnology as a platform for the production of biopharmaceuticals.

Plant-Based BioPharma

Where biopharmaceutical production depends on cells, eggs, yeast or bacteria to produce new medicines, agricultural biotechnology is giving rise to the use of plants as bioreactors for the production of pharmaceutical grade proteins such as monoclonal antibodies. Proponents of plant-based biopharmaceuticals point to several advantages, including lower costs and more rapid production, as well as a broader range of scalability – either large to meet global demands or small to provide personalised treatments – that can enhance not only health and welfare but provide new economic opportunities, especially in developing countries. Notwithstanding the many issues that are yet to be resolved surrounding the application of advanced plant technologies, plantbased medicines are a reality – and a reality evidenced by companies around the world that are in clinical trials with therapies and vaccines to treat the rarest to the most ubiquitous diseases.

One example is Israeli-based Protalix. In partnership with Pfizer, the company gained approval from the US Food and Drug Administration (FDA) for a February 2012 Phase 3 trial of taliglucerase alfa, a treatment for Gaucher disease, a rare genetic disorder caused by an enzyme deficiency. Protalix’ proprietary technology is based on genetic engineering and cell culture technology involving carrots and tobacco. The company is submitting applications for clinical trials in Europe, Israel and Brazil, and has additional drugs in development for Fabry disease, another rare genetic disorder, as well as biodefence and autoimmune diseases.

A new defence against HIV infections is an issue being tackled by Pharma- Planta, a consortium of over 30 academic and industry partners from Europe and South Africa. The group has developed an anti-HIV prophylactic containing the P2G12 antibody produced in tobacco plants, which received clinical trial approval in June 2011 from the UK’s Medicines and Healthcare Products Regulatory Agency. The same technology may be used to develop treatments for tuberculosis, rabies and malaria that along with HIV affect thousands of people, mainly in developing countries.

Influenza pandemic is another global threat. According to the World Health Organization (WHO), the 2009 H1N1 pandemic reached 74 countries and killed over 16,000 people. Vaccines took up to six months to be produced in traditional egg-based culture systems. Canadian-based company Medicago received positive results this year from an FDA Phase 1 clinical trial for an H1N1 vaccine, and is now in a Phase 2 trial for a vaccine that is recommended for H1N1, H3N2 and B influenza strains.

Both Pharma-Planta and Medicago have an enclosed cGMP greenhouse facility for growth, extraction and purification. Medicago’s proprietary technology, Proficia™, uses a transient expression system in the leaves of tobacco-relative Nicotiana benthamiana to produce a virus-like particle. The company predicts that they can produce vaccines within a month for testing against pandemic flu strains, and will be able to produce up to 10 million doses of influenza vaccine per month. The development of the vaccine was backed by a $21 million Technology Investment Agreement with the Defense Advanced Research Projects Agency (DARPA).

Advances in new therapies are being made not only in the field of plant-based medicines, but also for personalised medicine. In 2009, the FDA approved a clinical trial of a treatment developed by Bayer for non- Hodgkin’s lymphoma. Developed in a German-based pilot plant from viral vectors injected into tobacco leaves and transferred via Agrobacterium tumefaciens, a bacterium found in soil, the treatment is tailored to the markers of a patient’s tumours.

Also in 2009, the results of a UK clinical trial by Canadian company SemBioSys Genetics, Inc proved the bioequivalency of a recombinant human insulin called SBS-1000 made from safflower. In 2007, the company reported a 1.2 per cent accumulation of insulin within the seed protein of the plant, which translates to one acre of safflower providing enough insulin for 2,500 patients for a year, at a cost lower than traditional fermentation production methods for insulin using yeast or Escherichia coli. SemBioSys is filing an investigational new drug application with the FDA and a clinical trial application in Europe. In light of increasing incidences of diabetes, which WHO estimates at over 400 million people worldwide, a new source for insulin production can save and prolong lives globally.

Bioagriculture as Medicine

Bioagriculture is in itself a treatment for fighting disease by reducing the over-abundance of starvation and malnutrition in the world, while improving economic opportunity. The 2010 Global Status of Commercialized Biotech/GM Crops released by the International Service for the Acquisition of Agri- Biotech Applications (ISAAA) reports that “biotechnology is the fastest adopted crop technology in the history of modern agriculture,” which is evidenced by the growth in hectares from 1.7 million planted in 1996 to 148 million in 2010. The number of countries planting a variety of biotech crops – corn, maize, soyabean, cotton, sugarbeet, alfalfa, papaya, squash, tomatoes, peppers and potatoes – is now up to 29, 19 of which are developing countries and 10 industrial. That translates to 15.4 million farmers, over 90 per cent of which are identified as “small resourcepoor farmers in developing countries.” These 29 countries contain over half of the world’s population and 10 per cent of all worldwide cropland. The same report shows that the economic benefits of biotech crops between 1996 and 2009 are equivalent to $65 billion and are attributed to reduced production costs and increased yields.

The revival and expansion of the cotton industry is a powerful example of how biotechnology has given new life to an agricultural staple in world commerce. With the development of biotech cotton varieties, farmers are able to combat insects and weeds to grow cotton in areas where they couldn’t before. An article in the UN Chronicle entitled 'Biotechnology – A Solution to Hunger?' cited the use of Bacillus thuringiensis or Bt cotton in India. Due to Bt cotton’s ability to defend against pests, Indian farmers experienced a “31 per cent increase in its yield, 39 per cent decrease in insecticide use, and higher profits, equivalent to $250 per hectare.”

Second generation biofuels, which the United States Department of Agriculture (USDA) defines as the “application of technologies to woody biomass, wood waste, crop waste and non-food energy crops like switchgrass or sorghum, municipal waste and algae,” are another outgrowth of agricultural biotechnology that can increase economic opportunity, helping people out of poverty and therefore decreasing their exposure to disease. The advantage of the second generation feedstocks is that they are not food crops and can be grown on marginal land, reducing the pressure on overtaxed farmland and the competition with food crops. These advancements are coming at a time when the EU and countries like the US, China and Brazil are supporting the development of a biofuels industry through ambitious production mandates, tax credits and subsidies that are lowering costs and scaling production to meet local and worldwide needs for fuel alternatives that diversify energy resources, are more environmentally friendly and aid in rural development.

An AgBio Case Study

North Carolina is the third leading state for biotechnology in the US. The industry’s strength is due in part to the benefit farmers have gained from the first wave of agronomic traits that improved features such as drought resistance, nitrogen utilisation and other inputs by allowing them to lower their carbon footprints, increase yields and use less pesticides in several major row crops such as soyabeans, corn and cotton. The impact of Bt cotton in North Carolina is similar to that found in India. Because Bt cotton lessens the cost of managing weeds and insects, farmers in North Carolina are now planting cotton again. The most recent statistics available from the National Center for Food and Agricultural Policy identify biotech crops like cotton as adding a net value of more than $82 million to North Carolina’s agricultural industry, lessening the use of pesticides by more than 3.5 million lbs in 2006 and increasing food and fibre production by 86 million lbs. In a state that has lost over 100,000 manufacturing jobs since 2005, the economic strength of the agricultural industry, which provides over US $74 billion annually in revenue, is essential to sustaining jobs and boosting local economies. Farmers are now benefitting from a second wave of improved agronomic traits that are adding value to crops that benefit consumers by adding nutrients such as omega oils or vitamin precursors to common crops, many of which can be eaten in foods or extracted for high value use around the world.

Beyond Medicine, Food and Fuel

Agricultural biotechnology and the application of its related technologies in North Carolina, Israel, Europe, Canada and India are just examples of the global trend toward the recognition and use of plants and advanced plant technologies to address local and global challenges from the farm to the fuel tank to the medicine bottle. That is not to imply that the industry has all of the answers. Many ethical, legal and safety issues are yet to be addressed. The larger questions of political or socioeconomic import that directly impact economic opportunity and quality of life are outside the realm of any life science. Agricultural biotechnology is and will, however, continue to provide environmentally sustainable solutions that enable the production of medicines to fight disease, fuel required for heating, cooking and transportation and food to alleviate hunger and malnutrition.

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Gwyn Riddick is Vice President, Agricultural Biotechnology at the North Carolina Biotechnology Center. Gwyn joined the Center in 2003 with more than 35 years of experience in the life science and horticulture industries having previously held roles with Dow Chemical Company. He has also been a faculty member of North Carolina State University in Raleigh, and Director at Guilford Technical Community College. Gwyn received his BSc Degree in Microbiology from The Ohio State University, and an MBA from Butler University in Indianapolis. He is a Fellow of the Natural Resource Leadership Institute and member of the International Society of Pharmaceutical Engineers. Email:
Gwyn Riddick
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