People have been harnessing biological processes to improve their quality of life for some 10,000 years, beginning with the first agricultural communities. Approximately 6,000 years ago, humans began to tap the biological processes of microorganisms in order to make bread, alcoholic beverages, and cheese and to preserve dairy products. But such processes are not what is meant today by biotechnology, a term first widely applied to the molecular and cellular technologies that began to emerge in the 1960s and ’70s. A fledgling “biotech” industry began to coalesce in the mid- to late 1970s, led by Genentech, a pharmaceutical company established in 1976 by Robert A. Swanson and Herbert W. Boyer to commercialize the recombinant DNA technology pioneered by Boyer and Stanley N. Cohen. Early companies such as Genentech, Amgen, Biogen, Cetus, and Genex began by manufacturing genetically engineered substances primarily for medical and environmental uses.
For more than a decade, the biotechnology industry was dominated by recombinant DNA technology, or genetic engineering. This technique consists of splicing the gene for a useful protein (often a human protein) into production cells—such as yeast, bacteria, or mammalian cells in culture—which then begin to produce the protein in volume. In the process of splicing a gene into a production cell, a new organism is created. At first, biotechnology investors and researchers were uncertain about whether the courts would permit them to acquire patents on organisms; after all, patents were not allowed on new organisms that happened to be discovered and identified in nature. But, in 1980, the U.S. Supreme Court, in the case of Diamond v. Chakrabarty, resolved the matter by ruling that “a live human-made microorganism is patentable matter.” This decision spawned a wave of new biotechnology firms and the infant industry’s first investment boom. In 1982 recombinant insulin became the first product made through genetic engineering to secure approval from the U.S. Food and Drug Administration (FDA). Since then, dozens of genetically engineered protein medications have been commercialized around the world, including recombinant versions of growth hormone, clotting factors, proteins for stimulating the production of red and white blood cells, interferons, and clot-dissolving agents.
In the early years, the main achievement of biotechnology was the ability to produce naturally occurring therapeutic molecules in larger quantities than could be derived from conventional sources such as plasma, animal organs, and human cadavers. Recombinant proteins are also less likely to be contaminated with pathogens or to provoke allergic reactions. Today, biotechnology researchers seek to discover the root molecular causes of disease and to intervene precisely at that level. Sometimes this means producing therapeutic proteins that augment the body’s own supplies or that make up for genetic deficiencies, as in the first generation of biotech medications. (Gene therapy—insertion of genes encoding a needed protein into a patient’s body or cells—is a related approach.) But the biotechnology industry has also expanded its research into the development of traditional pharmaceuticals and monoclonal antibodies that stop the progress of a disease. Such steps are uncovered through painstaking study of genes (genomics), the proteins that they encode (proteomics), and the larger biological pathways in which they act.
In addition to the tools mentioned above, biotechnology also involves merging biological information with computer technology (bioinformatics), exploring the use of microscopic equipment that can enter the human body (nanotechnology), and possibly applying techniques of stem cell research and cloning to replace dead or defective cells and tissues (regenerative medicine). Companies and academic laboratories integrate these disparate technologies in an effort to analyze downward into molecules and also to synthesize upward from molecular biology toward chemical pathways, tissues, and organs.
In addition to being used in health care, biotechnology has proved helpful in refining industrial processes through the discovery and production of biological enzymes that spark chemical reactions (catalysts); for environmental cleanup, with enzymes that digest contaminants into harmless chemicals and then die after consuming the available “food supply”; and in agricultural production through genetic engineering.
Agricultural applications of biotechnology have proved the most controversial. Some activists and consumer groups have called for bans on genetically modified organisms (GMOs) or for labeling laws to inform consumers of the growing presence of GMOs in the food supply. The introduction of GMOs into agriculture began in 1993, when the FDA approved bovine somatotropin (BST), a growth hormone that boosts milk production in dairy cows. The next year, the FDA approved the first genetically modified whole food, a tomato engineered for a longer shelf life. Since then, regulatory approval in the United States, Europe, and elsewhere has been won by dozens of agricultural GMOs, including crops that produce their own pesticides and crops that survive the application of specific herbicides used to kill weeds. Studies by the United Nations, the U.S. National Academy of Sciences, the European Union, the American Medical Association, U.S. regulatory agencies, and other organizations have found GMO foods to be safe, but skeptics contend that it is still too early to judge the long-term health and ecological effects of such crops. In the late 20th and early 21st centuries, the land area planted in genetically modified crops increased dramatically; for example, between 1997 and 2002, the number of hectares allocated to genetically modified crops increased 30-fold.
Overall, the revenues of U.S. and European biotechnology industries roughly doubled over the five-year period from 1996 through 2000. Rapid growth continued into the 21st century, fueled by the introduction of new products, particularly in health care.