Overview

Bioindustry represents the particular mix of firms and activities that characterize life science activities, excluding health care delivery, in Arizona. Definitions of bioindustry, biotechnology, and medical devices follow, after which a brief overview of the industry is provided.

Bioindustry Definition
Primary Bioindustry Activities
Definition of Biotechnology
Definition of Medical Devices
Characteristics of Bioindustry Sectors
Medical Devices and Instrumentation
Health Care Biotechnology
Agricultural Biotechnology
Environmental Biotechnology
Industrial Biotechnology
Universities, Science and Society
Technology Transfer from Universities to Market

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Bioindustry Definition
The bioindustry is comprised of:

• The application of biotechnology and other advanced life science methodologies to the creation or alteration of life forms and processes
• The application of advanced physical science theory and techniques to research in:
  - agriculture
  - biomedicine
  - chemical, electrical, and computer engineering
  - mechanical and optical engineering
  - materials science
  - allied sciences involved in development of medical devices

The application of computer-based management information systems and statistical methods to the preceding activities

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Primary Bioindustry Activities
The study concerned itself with activities in two major areas:

Life Science Applications

• Pharmaceuticals and related products
• Research, testing, and production using bioreactors and similar devices
• Environmental research and applications using advanced biotechnology theories and techniques
• Industrial processes
• Modification of plants and animals using advanced life science technologies

Physical Science Applications

• Computer hardware and software and other advanced equipment required for research tracking, outcomes analysis, and development of life science products (e.g., automated DNA sequencers, cell fractionators and sorters, macromolecular synthesizers and their subcomponents)
• State-of-the-art devices that assist, maintain, or test human and animal health (such as artificial limbs, cardiac pacemakers, renal dialyzers, blood analyzers, brain and body imagers) and the equipment used to calibrate such devices

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Definition of Biotechnology
Biotechnology is a term used to describe a set of tools developed since the mid-1970s to deal with cells and other objects derived from complex organisms in tissue culture. Activities include isolation, manipulation, and transfer of genetic material between cells; precise analysis of nucleic acids and proteins; and production of substances such as reagents that allow extraordinarily specific and quantitative measurements to be made in the presence of monoclonal antibodies. The tools have application in a wide variety of biological endeavors ranging from diagnostics and therapeutics to pathology, plant and animal breeding, environmental remediation, and industrial production of various products.

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Definition of Medical Devices
Medical devices include any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar related article, including any component, part, or accessory that is:

• Recognized in the official National Formulary, or the United States Pharmacopoeia
• Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in humans or animals, or
• Intended to affect the structure or any function of the body of humans or animals, and which does not achieve any of its principal intended purposes through chemical action within or on the body of humans or other animals, and which is not dependent on being metabolized for the achievement of any of its principal intended purposes

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Characteristics of Bioindustry Sectors
The two components of the bioindustry, biotechnology and medical devices, are often treated separately in reports, histories, and other publications. However, advanced medical device research and development (R&D) in areas such as vascular implants, artificial organs, tissue engineering, and medical and scientific instrumentation is beginning to merge with activities commonly associated with biotechnology. Further, both advanced medical device and biotechnology enterprises are characterized by intensive and highly reciprocal cross-traffic among private-sector firms, academia, government labs, and private research institutes. In both sectors, the result has been the emergence of new organizational forms featuring an open architecture of networks rather than the more traditional horizontal and vertical structures of industrial sectors. Indeed, both biotech and medical device firms may participate in the same networks. These networks are fluid, and their form and membership change depending on the particular project and its stage of development. Because both fields are complex, the following discussion treats biotechnology and medical devices separately; however, it is important to keep in mind that there are strong linkages and commonalties between them.

Research and development within the bioindustry is highly interdisciplinary in nature, and activities tend to be categorized according to the primary sector in which the researchers and firms operate, rather than according to Standard Industrial Classification (SIC) Code. Generally speaking, the bioindustry can be subdivided into five sectors: medical devices and instrumentation, health care biotechnology, agricultural biotechnology, environmental biotechnology, and industrial biotechnology.

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Medical Devices and Instrumentation
The U.S. medical device industry is respected worldwide for the quality of its products, its cutting-edge technology, and its services. The industry produces a very wide array of devices and instruments, which are marketed either to health care professionals or directly to consumers. Of particular interest to Arizona bioindustry development are products emerging from the advanced-technology sector of the industry, including, for example, artificial organs, implants of various kinds, fixators, surgical clamps, and sophisticated imaging devices. The industry's commitment to R&D has enabled it to maintain this leadership and has contributed to shorter hospital stays and faster recoveries for patients.

As is the case with biotechnology firms, medical device companies are typically small. Other similarities with biotechnology firms are:

• A preference for being close to research universities
• Considerable interaction between universities and medical device firms
• Substantial reliance on a highly skilled workforce
• An emphasis on research-intensive work

The industry was not strongly regulated before 1983; today, however, a complex set of regulations governs the industry and its products.

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Health Care Biotechnology
Health care biotechnology employs the human body's own tools and weapons to fight disease. Biotechnology medicines and therapies rely on enzymes, hormones, proteins, antibodies, and other substances that are naturally produced in the body, or that are engineered from natural structures, to fight infections and diseases and to correct genetic disorders. This branch of biotechnology also uses other living organisms including plant and animal cells and substances derived from marine life forms, viruses, and yeasts to produce new medicines. The four primary areas of human health care where biotechnology is currently being used are:

• Medicines: Biotechnology medicines approved for use presently are proteins that help the body fight infections or carry out specific functions. Among biotech medicines approved by the Food and Drug Administration (FDA) are products to treat anemia, cystic fibrosis, growth deficiency, hemophilia, leukemia, hepatitis, genital warts, transplant rejection problems, and various forms of cancer.
• Vaccines: Biotechnology vaccines differ from conventional vaccines, which use weakened or killed forms of a virus to introduce antigens that the body uses to identify the virus and produce antibodies to fight it. In contrast, biotechnology vaccines consist only of the antigenónot the actual virus; thus, they cannot transmit the virus itself. The FDA has approved the use of a biotech vaccine for hepatitis B. Work continues on vaccines to combat influenza, AIDS, and herpes viruses, as well as Rocky Mountain spotted fever and various human and animal diarrheal diseases.
• Diagnostics: Biotechnology diagnostics are used in the detection of many types of disease and genetic conditions. For example, biotechnology-based assays are used to screen donated blood for HIV and hepatitis. Home pregnancy tests and cholesterol screening products are other examples of diagnostic products developed through biotechnology.
• Gene Therapy: This promising technology uses genes themselves as drugs to correct hereditary genetic disorders by replacing faulty or missing genes. For example, gene therapy has been used to treat severe combined immune deficiency (SCID).

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Agricultural Biotechnology
Many consider biotechnology to be the next step in the evolution of agricultural activities that span a large portion of human history. Biotechnology tools enable scientists to produce plants and animals that provide better nutrition, flavor, and yield. Agricultural biotechnology products have been slower to reach the market than have products in other sectors, most notably the health care sector, but they appear to have enormous potential for generating wealth and improving world nutrition.

Many of the advances in the field have involved the genetic engineering of plants and animals to produce particular characteristics, such as resistance to frost, pathogens, heat, insects, and other stresses. The industry holds promise for increasing crop yields without increasing reliance on chemical pesticides and herbicides. Biotechnology also enables new strains of plants and animals to be produced more rapidly and efficiently, allowing for faster movement from laboratory to market. Among biotechnology agricultural products currently on the market are TXN Cotton (produced by Calgene, Inc.), FLAVR SAVR tomatoes (Calgene, Inc.), CIBA Maximizer Hybrid Corn (Ciba Seeds), and FreshWorld Farms Carrot Sticks (DNA Plant Technology Corporation). Chymosin, an engineered enzyme, is now used in production of most of the varieties of cheese on the market and is marketed by two competing firms under different brand names. Among products close to reaching the market are a genetically engineered cotton fiber; raspberries, strawberries, and tomatoes with delayed ripening and longer shelf life; and a new type of salmon that can grow from egg to market size (8 to 10 pounds) within 12 to 18 months.
Another type of agricultural biotechnology is development of biopesticides and similar products. Several biopesticides, based on natural agents such as microorganisms and fatty acid compounds, are already on the market. These products are toxic only to the targeted pests and cause no harm to humans, animals, fish, birds, or beneficial insects. Pheromones are also used in biotechnology-derived products. In these cases, the pheromones attract insects away from crop plants, as was done to control fruit fly infestations in California.

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Environmental Biotechnology
Environmental biotechnology often involves the use of living organisms that have been engineered to feature specific traits, in order to identify, control, or prevent environmental pollution. Environmental biotechnology products and processes frequently clean up hazardous wastes more efficiently than conventional methods, greatly reducing the need for incineration or use of hazardous waste dumps. Bioremediation is being used for cleanup of many types of pollutants, including petrochemicals, TNT, heavy metals, and sewage, as well as waste from breweries, paper manufacturing plants, and chemical production facilities.

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Industrial Biotechnology
Industrial biotechnology involves using enzymes to enhance the rate of desired chemical reactions, to create improved products, and to perform other functions such as processing starch and converting grains. Currently about 50 enzymes are used in industry, most of which are used to break down large molecules into simpler ones. Laundry detergents are a good example of this use. One of the very large markets for grain-conversion processing in the United States is the high fructose corn syrup market. An example of product improvement is the indigo dye used in denims, now derived through biotechnology methods of chemical synthesis using glucose. This process eliminates the hazardous waste generated by traditional processes used in transforming natural indigo into dye.

A subsector of industrial biotechnology is biomanufacturing, wherein living cells or microorganisms are used to produce an array of products, including pharmaceuticals, biomembranes, and other materials and products. Metabolic engineering, one type of biomanufacturing, uses recombinant DNA technology to enhance cell activity through manipulation of the cell's metabolic pathways. Another application of industrial biotechnology, biomass conversion, involves use of organic polymeric materials (such as lignin, starches, celluloses, and oils) that are produced through biological processes. Products such as commodity chemicals, fuels, animal feed, and specialty products (such as flavors, fragrances, and pigments) are significant areas of opportunity in this field. DNA typing procedures and services are currently being used for establishing paternity, in management of wildlife populations, and in forensic testing including definitive identification of famous people such as Tsar Nicholas II of Russia and his family. Another application, biorefining, involves using microbes to process minerals. Biorefining is environmentally friendly and in some cases can recover minerals and resources that otherwise would be inaccessible.

Biosensors are invaluable in the design and operation of automated and environmentally benign manufacturing processes, as well as in detecting, monitoring, and controlling food additives and food safety. The three major components to a biosensor are a biological component (such as an enzyme, immunoprotein, or nucleic acid), an interface (such as a polymeric thick or thin film), and a transducer (which converts the biochemical interaction into a quantifiable electrical or optical signal). Biosensors have attracted a great deal of interest and are the target of intensive R&D.

Bioelectronics is an emerging technology that uses biological molecules in conventional integrated circuit technology or in unconventional applications such as optical processes. Research in this area focuses on constructing devices at the molecular level that are capable of storing data at extremely high densities, and on developing nano-scale computers. Although biological systems function more slowly than solid-state devices, this disadvantage is more than offset by the huge increase in potential density of operating units. The major technical obstacle to development of bioelectronic devices is determining how to preserve and control the active state of the bioactive component when it is immobilized in an artificial membrane. Biological self-assembly may be a potential resolution to this issue.

Biomaterials are materials produced by biological organisms; for example, silk obtained from spiders and ceramics from seashells. Considerable R&D interest focuses on development of new biomaterials for specific needs, including materials with few or no impurities or byproducts. Associated with this endeavor is tissue engineering, which refers to developing biological substitutes that can restore, maintain, or improve human tissue function. Bioengineered human skin is already in clinical trials. Researchers are also working on developing blood vessels; bone; cartilage; and nerve, bone marrow, liver, and pancreatic cells that can be grown into tissues.

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Universities, Science, and Society
The scientific enterprise in the United States arose in the wake of World War II. The system we have today is unique to the United States. It is characterized by an unmatched blend of public and private enterprises, including research universities, private research institutes, private-sector firms, non-profit organizations, and national laboratories such as the biomedical facilities at the National Institutes of Health (NIH), military R&D such as the Los Alamos and Lawrence Livermore National Laboratories, and mission-oriented agencies such as the National Science Foundation (NSF) and the National Aeronautics and Space Administration (NASA). The support for science in the United States has traditionally been predicated, in part, on the likelihood of economic benefit from scientific research some time in the future. And indeed, the American system of science, Whether measured in terms of people, products, patents, publications or prizes has been the most successful in the world.

By far the largest source of funding for the U.S. science and technology enterprise most of which has been carried out at U.S. research universities has come from the federal government. For more than 50 years, the fundamental driving forces behind federal support of university research and education have been national security and health care. A reasonable working relationship between universities and the federal government, in particular, is crucial to the success of the bioindustry, for discoveries and innovations arising from federally sponsored R&D continue to supply important inputs to the commercialization of life science-based products. Much of the rationale for today's public funding of science arises from the belief that science-based innovation is an essential (though not the only) factor in maintaining and revitalizing the nation's economy and its internationally competitive position. While the United States remains the world leader in bioscience and in the bioindustry, it must continue to actively fund science and technology efforts in order to maintain that position in the face of rising foreign competition.

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Technology Transfer from Universities to Market
Technology transfer refers to the movement of knowledge and innovations from a research institution to other entities (or between private-sector entities), usually for the purpose of realizing the innovation's commercial potential. With regard to universities, these innovations may arise from university-based research (including federally funded research, which is the predominant form), from research funded by private industry or non-profit organizations, or through the use of incubator or similar arrangements. The intensity and nature of university/private-sector linkages vary considerably by industry sector, with biotechnology and biomedicine having considerably stronger linkages with universities than does, for example, advanced parallel computing.

The rise of technology transfer activities within universities was stimulated by enactment of the 1983 Bayh-Dole Act. Most transfers are licensing arrangements, which is the transfer method preferred by universities. For publicly supported universities, achieving a return on investment of public funds while protecting the public's fiduciary interests has become an important function. Aside from protecting the public trust, universities are also responsible for protecting the intellectual property and publication rights of their faculty and researchers and for averting any conflicts of interest between the university functions and entrepreneurial activities of university employees. These requirements are a common source of conflict in university/private-sector interactions. ASU and UA both maintain active technology transfer offices. At both universities, technology transfer officers actively seek out disclosures of new inventions from faculty and researchers, and participate in the patenting of inventions, marketing of commercializable innovations, and negotiation of contracts.