Executive Summary

The United States has dominated the discovery phase of biology and laid the groundwork for commercialization of biotechnology. Biotechnology-derived products already affect human health, nutrition, and environmental improvement and will grow to provide new products and employment in new industries. Worldwide markets for biotechnology-derived products are projected to grow to at least $50 billion per year within the next 10 years, and our global trading partners are concentrating their resources on translating the discoveries of biology into economically viable products through bioprocess engineering.

Bioprocess engineering is the subdiscipline within biotechnology that is responsible for translating life-science discoveries into practical products, processes, or systems capable of serving the needs of society. It is critical in moving newly discovered bioproducts into the hands of the consuming public. Although the United States has nurtured the discovery phase of biotechnology, it has not been aggressive in developing bioprocess engineering.

BIOPROCESS ENGINEERING AND GLOBAL COMPETITIVENESS

The importance of engineering capability in achieving and maintaining global competitiveness is compelling; witness the growth of the pharmaceutical industry after the development of penicillin production during World War II and of the computer and electronics industry after the discovery of the transistor. The strength of the United States in engineering and manufacturing technology made major contributions to America's early dominance of world markets in both instances.



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Putting Biotechnology to Work Bioprocess Engineering Executive Summary The United States has dominated the discovery phase of biology and laid the groundwork for commercialization of biotechnology. Biotechnology-derived products already affect human health, nutrition, and environmental improvement and will grow to provide new products and employment in new industries. Worldwide markets for biotechnology-derived products are projected to grow to at least $50 billion per year within the next 10 years, and our global trading partners are concentrating their resources on translating the discoveries of biology into economically viable products through bioprocess engineering. Bioprocess engineering is the subdiscipline within biotechnology that is responsible for translating life-science discoveries into practical products, processes, or systems capable of serving the needs of society. It is critical in moving newly discovered bioproducts into the hands of the consuming public. Although the United States has nurtured the discovery phase of biotechnology, it has not been aggressive in developing bioprocess engineering. BIOPROCESS ENGINEERING AND GLOBAL COMPETITIVENESS The importance of engineering capability in achieving and maintaining global competitiveness is compelling; witness the growth of the pharmaceutical industry after the development of penicillin production during World War II and of the computer and electronics industry after the discovery of the transistor. The strength of the United States in engineering and manufacturing technology made major contributions to America's early dominance of world markets in both instances.

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Putting Biotechnology to Work Bioprocess Engineering The U.S. ambivalence toward bioprocess engineering is an inadvertent consequence of the high biochemical potency of the protein-based pharmaceuticals introduced between 1982 and 1989 whose worldwide markets are measured in kilograms per year and whose sales are in billions of dollars. But the situation is changing. The emerging families of food, agricultural products, and industrial chemicals to be generated by biological routes, as well as the biopharmaceutical products now in development, will have markets measured in thousands of kilograms, or more, and will require innovative manufacturing techniques. The participation of the United States in the expanding bioproducts markets will necessitate world-class bioprocess engineering. Comparison of the global competitive position of the United States with that of other technologically advanced nations in biotechnology and bioprocess engineering reveals that The United States continues to be the world leader in basic health-science and life-science elements of biotechnology. Japan leads in applied microbiology and biocatalysis and is effectively coordinating government, industrial, and academic resources in biotechnology and bioprocess-engineering development. Europe matches Japan in progress in applied biocatalysis and is establishing a strong, government-supported technology-transfer infrastructure between industry and academe with emphasis on bioprocess engineering. World competition in biotechnology and other industries that depend on bioprocess engineering will be keen because of the notable capabilities in and commitments to biologically relevant manufacturing and bioprocess development among industrially developed nations. It is debatable whether the United States can be dominant (or even competitive) in bioprocessing: university research and training programs are projected to grow by 75% in the best case while the industry grows by 1,000% in the next 10 years. The committee concurs with the Federal Coordinating Council on Science, Engineering, and Technology assessment that ''manufacturing/bioprocessing is an area in which biotechnology offers vast potential rewards. The total federal investment of $99 million in FY 1992 is small in proportion to its potential.'' The committee recommends that the U.S. government promptly take action and provide suitable incentives to establish a national program in bioprocess-engineering research, development, education, and technology transfer. That will require that the existing resources of government, industry, and academe collaborate in Rapidly translating scientific discoveries into marketable products and processes.

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Putting Biotechnology to Work Bioprocess Engineering Promoting cross-disciplinary research and education and thereby fostering innovative, multidisciplinary solutions to important bioprocessing problems. Providing a growing cadre of bioprocess engineers to meet the needs of an expanding bioprocess-industry. OPPORTUNITIES The committee addressed trends in biotechnology that are likely to have important worldwide social and financial impact within the next 10 years. In this context, current commercial activities related to biotechnology and biotechnology products are dominated by biopharmaceutical biologics, such as insulin, tissue plasminogen activator, and erythropoietin. Innovative bioprocess engineering in the manufacture of these products can lead to improvements in product recovery, product purity, process safety, and reduced manufacturing and quality-control costs. The need for such process innovation will intensify as patent protection for these products expires, global competition for international markets increases, and regulatory procedures that would otherwise slow introduction of new bioprocess technologies are streamlined. Health-care products emerging from biotechnology will be consumed in much larger quantities around the world than they are now (examples include recombinant hemoglobin, recombinant albumin, and conjugate vaccines). These second-generation products will require large-scale manufacturing facilities that handle biological systems; and bioprocess engineering will be a sine qua non for successful commercialization of the products. Bioprocess engineers will be employed in applying the new biology to producing smaller molecules and specialty bioproducts. These are in a category where the challenge is to apply bioprocessing to obtain value-added products and to engineer large-scale, integrated processes that use agricultural and forestry-based materials and other renewable resources. Bioproducts for use in food production and in foods (animal health-care biologics, biological plant-growth promoters and pesticides, nutritional supplements, and food additives) present large-tonnage product opportunities that can be tapped in the coming decade, provided that suitably efficient and economical manufacturing facilities can be designed and built. Such capabilities do not exist, and their creation is a major challenge for bioprocess engineering. The use of biomass for the production of industrial chemicals and of liquid and gaseous fuels represents a major hope for reducing U.S. dependence on imported hydrocarbons. The processing of renewable resources must have high national priority in the coming decade, so that the necessary know-how and production infrastructure for its practical implementation can be developed. Bioprocessing in space presents unique opportunities, particularly in bioregenerative life support and as a research platform for the study of new types of manufacturing processes.

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Putting Biotechnology to Work Bioprocess Engineering Bioprocessing for protection and beneficiation of the environment represents another large and important opportunity. Biological processes could offer alternatives to environmentally polluting or fossil-fuel-consuming manufacturing processes and could help to remove toxic pollutants from industrial and municipal wastes. Bioremediation's promise is in its potentially lower cost, compared with other types of technology for cleaning up the environment. NEEDS Generic applied research is critical to the optimal exploitation of bioprocess engineering by industry, in that it addresses technologies that are too risky for companies or that require too long a period for results. This category of research bridges the gap between basic biological science that is carried out by university and government laboratories and the industrial applied research that assists in converting biotechnology into products and services. For biopharmaceuticals, needs identified by the committee are to Improve analytical methods that facilitate rapid testing of products for purity and activity. Develop high-resolution protein-purification methods for scaleup and application in the industrial manufacture of ultrapure products. Develop process-control technology for integrating biological production sequences into stable and robust automated manufacturing systems. Enhance biological and biochemical technology for increasing the efficiency of protein folding and improving the expression of recombinant proteins. For specialty bioproducts and industrial chemicals, key needs are to Develop separation and purification technologies that are specially adapted to the recovery of products from dilute aqueous streams characteristic of materials derived from microbial fermentation, plant cell culture, or whole plant material. Develop processing technologies that will facilitate the economical conversion of cellulose-based materials into industrial chemicals and fuels. Develop specially adapted or genetically altered microorganisms that can transform biomass materials into industrial chemicals and other products. Develop bioproduct manufacturing processes that are controlled and regulated and have predictable performance. Appropriate bioreactor design and operating conditions must be implemented on scaleup to ensure that product characteristics are maintained,

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Putting Biotechnology to Work Bioprocess Engineering regardless of the type of product. Bioprocess engineers are particularly well suited to integrate bioreaction engineering concepts with the subtleties of cellular metabolism to achieve the necessary product qualities. Bioprocess engineering input is important for environmental applications of biotechnology, where the needs are to Study the role of microbial interactions in degrading of toxic wastes in the environment and detoxifying industrial wastes at the plant site. Define standards by which the effects of bioprocessing in detoxifying wastes will be measured. Implement bioprocess-engineering methods in the design of waste-processing technologies. RECOMMENDATIONS To meet the global challenges of competition in industrialization of biotechnology and to address national needs, the committee recommends A coordinated, long-term plan of research, development, training, and education in bioprocess engineering, with well-defined goals that involve participation of industry, academe, and the federal government. A research and educational program in bioprocess engineering that emphasizes cross-disciplinary interactions between scientists and engineers and a multidisciplinary team approach to problem-solving, which has historically been the keystone of success in American industrial development. Increased cooperation between industry and the Food and Drug Administration for the express purpose of developing quality-control methods and standards and good manufacturing practices for the manufacture of biotechnology products. Sustained funding by the federal government is essential to the success of research and education programs for training bioprocess engineers, as is the participation of industry—in planning, training, and supply of physical and financial resources. The ability of the United States to sustain a dominant global position in biotechnology lies in developing a strong resource base for bioprocess engineering and bioproduct manufacturing and maintaining its primacy in basic life-science research. The United States has made an enormous, and enormously successful, investment in basic biological science. To protect the investment and to capitalize on it, there must now also be an investment in bioprocess engineering.

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Putting Biotechnology to Work Bioprocess Engineering A PLAN FOR ACTION The discoveries emanating from the basic life sciences provide the knowledge that supports new concepts for biologically based products and manufacturing systems. The committee strongly recommends that federal funding of research in biotechnology be extended to support efforts that provide the science and technology base for producing and manufacturing products from biology. Targeted long-term research support would speed the development of commercial products, provide the trained personnel needed to support industrial activities, protect entry-level U.S. products, provide the basis for low-cost production of the largest-volume (and highest-revenue) products, and help to integrate processes and concepts from biological science and bioprocess engineering. The Committee on Bioprocess Engineering recommends these actions to improve U.S. strength in bioprocess engineering and U.S. competitiveness in commercial biotechnology. Human-Resources Development The committee recommends a major commitment to developing the human-resources base through funding of research programs in universities, continuing-education programs, and research directed toward industrial problems (applied-engineering research) by the cognizant government agencies, including the National Science Foundation (NSF), the National Institutes of Health (NIH), the Department of Energy (DOE), and the Department of Agriculture (USDA). New resources must be provided to strengthen the infrastructure for bioprocess engineering and biotechnology in this context. A major commitment is needed to educate personnel skilled in bioprocess engineering. These are the individuals who will develop bioprocesses and support biologically based manufacturing technologies if the U.S. biotechnology industry is to remain competitive with those of Japan and Europe. Assessing Developments Abroad The committee recommends vigorous efforts in technology assessment in Japan and Europe and support for exchange-scholar, exchange-student, and collaborative research programs. For bioprocess engineering, particular emphasis should be placed on tracking developments in process technology for manufacture of new bioproducts. Germany, Switzerland, Austria, the United Kingdom, France, Scandinavia, Italy, the Netherlands, and other European nations have a strong base serving biotechnology in products and services. Given the upcoming economic unification of Europe, we recommend a separate study on bioprocessing in Europe.

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Putting Biotechnology to Work Bioprocess Engineering Cross-disciplinary Research Several government-agency programs, including those of the NSF Engineering Research Center Initiative and the NIH Interdisciplinary Biotechnology Training Grant Program in the National Institute of General Medical Sciences, foster cross-disciplinary and interdisciplinary training. Cross-disciplinary research should be part of the training of the bioprocess engineer and include activities at the postgraduate level. For example, a postdoctoral scholarship program for biological scientists to gain exposure to engineering activities should be considered. The committee recommends that cross-disciplinary interactions continue to be fostered by the programs of NSF, NIH, USDA, and DOE. Promoting Awareness of Importance of Manufacturing Technology The committee strongly recommends formulating a federal strategy for fostering increased awareness of the importance of manufacturing technology in the research and university communities through education and training. Postdoctoral and graduate students should have contact with issues in manufacturing through research, course work, teaching laboratories, and industrial experiences. Continuing education is also critical for bioprocess engineering because of the rapidity of advances in the biological sciences and should be part of the training offered by universities to leaders in the bioproduct industry. Such programs should be created by industry, universities, and government in a cooperative fashion. Teaching laboratories for bioprocess engineering should be upgraded so that they can provide a high-quality training experience for a larger number of students. Competitive-Grants Program The committee recommends that research funding be allocated to topics listed in this report through a competitive-grants program for bioprocesses in the manufacture of biopharmaceuticals and other bioproducts that cover a wide range of biological, chemical, and engineering disciplines. We believe that structuring the research in a manner that requires an industry-university or industry-government interaction would catalyze further research. Role of National Laboratories and Research Centers Industry involvement and the special facilities and capabilities of government laboratories, such as those under the auspices of USDA and DOE, could help to speed adaptation of some types of new bioprocesses on a commercial scale. Similarly, the NSF Engineering Research Centers pro

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Putting Biotechnology to Work Bioprocess Engineering gram and more recently the National Aeronautics and Space Administration Scientific Centers for research and training provide cross-disciplinary environments for research related to manufacturing or large-scale systems. The committee recommends that these laboratories and centers be examined as models and applied, in a suitably modified form, to the processing of renewable resources. Bioprocessing for Cleanup of Environmental Hazards The committee recommends an analysis of the costs of biological treatment compared with other technologies. Bioremediation promises lower costs than other types of technology for cleaning up certain environmental hazards.