Biopharming Has a Tough Row to Hoe

By Henry I. Miller, MS, MD — Jan 16, 2023
Plants can be genetically modified to produce high-value pharmaceuticals, a practice called “biopharming.” Many of these "biopharmed" vaccines and other biologics do not require refrigeration, special handling, or sophisticated medical equipment to distribute them, making them ideal for middle and low-income countries. They are also cheaper to produce than our current methods and can help reduce the increasing costs of biologics. But these products have not yet entered the marketplace in part because of regulatory constraints.

This is an excerpt. Please see the original article in the journal Regulation:

Obtaining medicines from plants is not new. Aspirin was first isolated from the bark of the willow tree in the 18th century, and many other common pharmaceuticals have been purified from the world’s flora. These medicines include morphine, codeine, digitalis, the laxative Metamucil, and the anti-cancer drugs paclitaxel and vinblastine. A notable plant-derived product that has emerged from traditional Chinese medicine is artemisinin, an important treatment for malaria.

Spurred by the COVID-19 pandemic, many laboratories are reorienting their research to not only look at promising compounds that occur naturally in plants but also to manipulate plants to produce high-value pharmaceuticals, a practice called “biopharming.” Academics and biotech companies are using molecular genetic engineering techniques to reprogram plants—including corn, potatoes, rice, and bananas, among others—to produce significant concentrations of pharmaceuticals, including vaccines. Unfortunately, this promising research is being hindered by overregulation.

Biopharming’s great promise lies in using genetic engineering techniques to make old plants do radically new things, often more cheaply than is possible with non-plant platforms. The technology is similar to that used to insert genes into non-plant organisms, as has been done for decades. For instance, the gene that expresses human insulin was inserted into the bacterium E. coli, and the genetically modified bacteria have been the source of that critical drug since 1982. Similarly, genetically engineered baker’s yeast that contains the gene for a surface protein of the hepatitis B virus has been the source of the hepatitis B vaccine since 1986.

There is great potential for cost-cutting in the biopharming process. The energy for product synthesis comes from the sun, and the primary raw materials are water and carbon dioxide. In addition, biopharming offers tremendous flexibility and economy when adjustments in production are necessary. Doubling the acreage of a crop requires far less capital than doubling the capacity of a brick-and-mortar factory, making biopharmed drugs potentially much less expensive to produce than those made in conventional ways. The quality of the final drug can meet the same standards as current fermentation technology using microorganisms, and grain from a biopharmed crop can be stored safely for long periods with no loss of bioactivity.

Many biopharmed vaccines and other biologics have been shown to be cheap, safe, and efficacious and do not require refrigeration or sophisticated medical equipment to distribute them. But these drugs have not yet entered the marketplace in part because of regulatory constraints.

When new restrictions on biopharmed crops were announced in 2003, then Agriculture Secretary Ann Veneman told reporters, “It’s very important that we regulate in a way that allows this technology to proceed, so we can reap the benefits of it.” Instead, the department is regulating in a way that will ensure that the field is stigmatized, that biopharming’s research costs are hugely inflated, that only high-value-added products will be candidates for development, and that consumers ultimately will see few biopharmed drugs in the pharmacy. Moreover, in these circumstances, there is little chance that pharmaceutical companies will develop many products designed for less developed countries where heat-stable, biopharmed drugs and vaccines could revolutionize health care.

Henry I. Miller, MS, MD

Henry I. Miller, MS, MD, is the Glenn Swogger Distinguished Fellow at the American Council on Science and Health. His research focuses on public policy toward science, technology, and medicine, encompassing a number of areas, including pharmaceutical development, genetic engineering, models for regulatory reform, precision medicine, and the emergence of new viral diseases. Dr. Miller served for fifteen years at the US Food and Drug Administration (FDA) in a number of posts, including as the founding director of the Office of Biotechnology.

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