Rapidly growing demand for engineered biomolecular products is creating strong market pull for efficient, cost-effective, and scalable alternatives to today’s conventional biomanufacturing technologies. The use of crop plants for biomanufacturing offers significant technical and economic advantages relative to other options now being developed, but a broad set of biosafety concerns and risks must be overcome if the tremendous – even revolutionary – potential of this approach to manufacturing can be fully realized.

The potential market opportunities for biomanufacturing are sizeable and growing rapidly across a diverse array of biological materials, including biopharmaceuticals, industrial enzymes, analytical reagents, dyes, lubricants, adhesives, polymers, liquid crystals, and more. Already, annual sales of therapeutic proteins total about $25 billion, with the top ten products in this category accounting for sales of almost $14 billion. Approximately 500 new biotherapeutic products, virtually all of which are genetically engineered, are currently in various stages of clinical trials in the U.S. and/or Europe, promising significant growth over the next five years.
           
Today’s conventional cell-culture based biomanufacturing technologies require capital intensive, fixed investments that are relatively inflexible in scaling up to meet growing production demands. Already, cell-culture production capacity is strained, and is likely to continue to be so in the years ahead. Crop-based production, primarily using corn or tobacco, is competing to augment and supplant more conventional cell-culture technologies, along with other new biomanufacturing alternatives, including the use of genetically engineered aquatic plants (notably duckweed and algae), and livestock (primarily goats and cows).

To date, bio-era has identified 80 recombinant pharmaceutical or industrial biomolecules that already have been produced, at least at experimental levels, in transgenic crops.  While none of these plant-made products is yet commercialized, ongoing technological advances are making crop-based production feasible and economical for a growing range of products.  Eventually, we expect the use of crop plants as platforms for the production of a wider range of engineered biomolecules extending beyond proteins to include oils (for nutritional and for chemical products), carbohydrates (including polymers), and secondary metabolites (for nutritional, pharmaceutical, and chemical uses).

Given the demands for biosafety and regulatory risk management, the prospects for large scale, open air, crop based biomanufacturing in the U.S. remain highly uncertain – despite the demonstrable technical and economic merits of the technology. As long as major questions and concerns over biosafety remain unresolved, large-scale commitments to the technology by major manufacturers in the biotechnology, pharmaceutical, and chemical industries are not likely to be made.  One consequence, in the short term, is that much of the development in this area will continue to be undertaken by small, aggressive biotechnology firms, funded with high-risk venture capital and working only on contract or in partnership with larger chemical or pharmaceutical partners.  Ironically, this dynamic, largely driven by the desire of the major established players to avoid or shed risk, seems to increase the chance of biosafety breaches – with potentially catastrophic consequences for the industry as a whole.