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Molecular Farming The direct applications of biotechnology in agriculture conveniently fall into two distinct categories: (1) improvements to existing livestock and crops, and (2) development of entirely new uses for plants and animals which will enable the farmer to address new markets. Examples in the first category (improvements) include the now commonly used ‘input traits’ such as crops with enhanced resistance to insect attack and improved weed control. ‘Output traits’ such as improved fruit quality, naturally colored cotton etc. are anticipated soon. ‘Molecular farming’ is the term commonly applied to the second category (new uses for plants and animals). Although it is not yet routinely practiced commercially, interest and investment in molecular farming with plants and animals is accelerating rapidly, and commercialization seems imminent.  The introduction of genes into plants like tobacco, corn, soybeans, alfalfa etc. to enable them to produce and accumulate new substances has been possible for many years. An abundance of scientific literature documents the successful production in tobacco and other plants of protein pharmaceuticals, vaccines and other medicinals, enzymes, polymers, food ingredients, etc. A variety of technologies have been developed to make these ‘plant factory’ systems possible, and the leading commercial research is now focused on optimizing the production systems and post-harvest bioprocessing aspects to the required standards (e.g. FDA specifications for human pharmaceuticals). (For more information on plant molecular farming, especially with tobacco, visit www.uky.edu/rgs/thri). The same general concept is also feasible with animal systems. Companies have been formed to commercialize the use of chicken eggs, goat milk, and insect larvae for this purpose, for example. The production of a variety of pharmaceutical and other proteins has been demonstrated. As with the plant systems, current commercial research and development also focuses on optimization of the overall scheme, including product purification and quality assurance. To appreciate the need for these new applications of plants and animals it is important to understand the essential requirement for biological systems in order to produce biological products. Protein medicinals like insulin and antibodies, enzymes for food processing and industrial applications, and certain environmentally ‘friendly’ polymers are all natural products of living things whose production by synthetic chemistry is often prohibitively expensive if not impossible. Economical manufacturing of these valuable biological substances must, of necessity, use biological systems. For a quarter of a century genetically engineered bacteria have been used highly successfully as the production ‘hosts’ for many medicinal proteins (insulin, growth hormone etc.) and a wide variety of enzymes. More recently, other microbial systems and cultured animal cells have contributed also. The use of transgenic plants and animals in addition to these fermentation-type approaches is the next logical continuation in the development of more environmentally compatible, more effective, biological products. While the various animal and plant molecular farming strategies might be thought of as competitive with each other, it seems more likely that certain products will be better suited to particular production systems. For example, cheap and very-large-scale production will be necessary for biodegradable plastics. For this purpose, extensive acreages (perhaps amounting to millions of acres) of crop plants such as tobacco, soybean etc. seem appropriate. In contrast, a medical product needed in extremely high purity to treat a very rare human disease condition might require ‘contained’ production such as would be provided by transgenic animals or plants maintained indoors in exceptionally clean environments. In addition to such product-specific requirements, molecular farming systems will also be influenced by safety and environmental regulations governing the product, the process, and the transgenic plant or animal concerned. Researchers developing molecular farming strategies recognize that commercial success depends just as much on these aspects as on overall cost-competitiveness. Molecular farming has been technically possible with plants for more than ten years, and with animals for at least half that time. Yet, commercial deployment of these technologies thus far has been slow. There are several reasons for this, such as the more direct path to market for crop input traits like herbicide tolerance. However, the prevailing opinion is that this situation is about to change dramatically as a result of remarkable new ‘end-user’ interest. Molecular farming has been promoted to-date largely by the companies which own the technology, and demand from the companies that would use the resulting products (‘end-users’) has been limited. However, in regard to protein medicinals for example, biotechnology is making possible a whole new series of products, some of which (antibodies, for example) will be administered in much higher doses than existing protein drugs. Some analysts predict that in comparison with the typical kilogram-scale annual production of a purified protein medicinal some of these anticipated new products could be required in metric tons per year. These kinds of quantities, and the expected multiplicity of new products, likely exceed the capability of expensive fermentation systems by a considerable margin. As a result, contract drug manufacturing organizations are taking new interest in plant and animal molecular farming systems. And once new products begin to appear in the market place from such systems we can expect a further increase in interest. If the emergence of significant new markets for novel products from plant and animal molecular farming seems likely in the next few years, what might this mean for the farmer? Perhaps the most exciting prospect is that of a totally new business opportunity. As an example, consider the tobacco farmer looking for alternatives to supplement declining demand for the traditional tobacco crop. Switching some production acreage to other conventional crops, or to niche-market ‘value-added’ opportunities (for example, ‘organic’ vegetables etc.) replaces a quota-based production system with a widely competitive situation. In contrast, molecular farming has the potential to create a new, dedicated business opportunity for farmers over the market lifetime of each particular product. In practice, much will depend on the product itself and the production system being used. Some products may require large acreages of crops grown in the open-field environment, benefiting many growers. Others may require installation of glasshouse facilities. And animal-based systems may be managed somewhat differently from today’s livestock, poultry etc. production. The next few years are likely to be the most interesting ones yet for molecular farming, as these aspects are developed and commercial production begins on a significant scale.