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Introduction RALPH HARDY To provide an overview of what is called the new biotechnology, we have assembled three of the leaders in this field from bioengineering, health care, and agriculture. But first a brief introduction. The reality of biotechnology is strikingly shown in Figure 1. Genes that direct the synthesis of the animal growth hormone were injected into the embryo of the rodent pictured on the left-hand side of the figure. The addition of genetic material by the new biotechnology led to a very substantial change up to a doubled size in this organism. Clearly, then, there is a reality to biotechnology. As discussed by Charles L. Cooney in the first of the three papers that follow, processes for many of the biotechnology applications require engineering input. Some believe, in fact, that the process aspect of this research may be more demanding than is the genetic manipulation as- pect. The reality of biotechnology in agriculture is illustrated by the knowl- edge that the change of a single amino acid in a protein that occurs in the membrane of the chloroplast, the light-gathering area of a plant, led to resistance to a major herbicide called atrazine. In fact, rapeseed with this resistant gene is now being aggressively used by farmers on the North American continent. Charles J. Arntzen provides an overview of this and other aspects of biotechnology in agriculture in the second paper. The reality of biotechnology in health care is demonstrated by the clinical use begun in 1982 of human insulin produced in a fermentation 39

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40 NEW FRONTIERS IN BIOTECHNOLOGY FIGURE 1 Size of organism doubled as a result of the addition of genetic material by the new biotechnology. Reprinted, with permission, from Science, Vol. 222, No. 4625, Nov. 18, 1983. (a) 1983 by American As- sociation for the Advancement of Science. vat in a microorganism into which had been inserted the genes for human insulin. J. Paul Burnett discusses this and other aspects of biotechnology in the health care area in the third paper. The examples mentioned thus far clearly show that there is a reality to biotechnology. And clearly the fundamental, pervasive ability of this technology the ability to manipulate in a directed sense the infor- mational system, or genes, of all living cells suggests that the reality of biotechnology will have impacts in a number of industries. These industries range from the nearer-term health care and agricultural areas through food, industrial chemicals, energy, forestry, pollution control, and mining, and possibly in time to bioelectronics. However, such a pervasive capability has unfortunately led to many unrealistic expectations. It seems that countries without substantial bio-

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INTRODUCTION 41 technological capability feel that they are not first-class countries, and the same thing has happened in many industries, among the public investors, and so forth. In the first six months of 1983, for example, the public committed about $250 million to new stock offerings to small biotechnology companies, almost all of which have no product now and which probably will not have a product for some time. Limited R&D partnerships in this area are beginning to become very popular. What we would like to do here, then, is to provide an analysis of what the reality is in this exciting field with the tremendous potential. Clearly the new biotechnology is in its very early stages.