1/87 BIOTECHNOLOGY - Japan Key Technology Center

1987 is thought to be the year when the f'irst blockbuster biotechnology developed product is expected to hit the market. The agent tissue plasminogen activator (TPA), which was developed using genetic engineering,, dissolves blood clots after heart attacks and helps prevent further attacks, is said to be that product.

Let’s look at the number of Japanese corporations which have succeeded in comnercializing biotechnology products by industry the companies are in are: chemicals (12 companies), pharmaceuticals (13 companies), foods (20 companies), animal breeding (8 companies), construction plant engineering (15 companies), electricl device's & machinery (17 companies), textiles and paper (5 companies)

In Japan the market for biotechnology related products is projected to reach 5.7.trillion yen by the year 2000. By that year 23 Japanese companies project that biotechnology related sales will account for as much as' 70% of their sales. Another estimate has it that by the year 2000 the bioindustry will account for 114 of Japan's GNP. During fiscal year 1986 average biotechnology sales at biotechnology related firms reached 1672 million yen with the firms: investing an average of 450 million yen in research and development efforts. Present commercialization of biotechnology is concentrated on food prodocts and pharmaceuticals. Equipment and chemicals are other strong areas. In terms of production methods, mass cell culture is the main emphasis in applying biotechnology; Other production methods include bioreactors', cell fusion and genetic engineering. At present, the highest profits are being generated in food products or pharmaceuticals using fermentation technology as well as facilities' for genetic engineering such as clean rooms.

GOVERNMENT SPONSORED' RESEARCH AND DEVELOPMENT In recent months some of the lead in the development of biotechnology has beeii taken up by the Ministry of Agriculture and Forestry and the Ministry of Health and Welfare while MITI is increasingly finding itself facing budget limitations, In October 1986 the Ministry of Agriculture and Forestry, together with 830 companies, formed the Bio-Oriented Technology Research Advancement Institution (BRAIN) and in the same month the Ministry of Health and Welfare and 91 corporations created a human science project organization. The following is a brief outline of major projects being sponsored by varibus government organizations and how much funding the ministry will provide during fiscal year 1987.

Ministry of International Trade and Industry. Development of biochip technologies (150 million yen). Planning for bioindustry promotioh measures (167 million yen). Promoting biotechnology in the R&D of Basic technoibgy for Future Industries (1232 million yen). Biomass related technologies development (874 million yen). Promotion of biotechnologies under the Conditional Loans for R & D of Innovative Technologies to Revitalize the Basic Materials Industry" project (426 million yen). Water recycling system research under the National R&D (large scale) project" (2123 million yen). Production of physiologically active substances via international cooperation (l27 million yen).

Ministry of Agriculture and Forestry:

Enzyme function transformation technology development for use in food production (110 million yen). Bioreactor development for use in food production (244 million yen). Bio-Oriented Technclogy Research Advancement Institution research (3800 million yen). Classification of genes, gene preparation and gene structural analysis (69 million yen). Protein engineering for heat resistant entymes. (110 million yen).

Ministry of Health and Welfare:

Loan system for health industries (1000 million yen). Life expectancy prolongation basic research (1041 million yen). AIDS research (110 millicn yen). Establishment of a Center for Health Research for developing biotechnology medicines and medical eguipment.

Science and Technology Agency:

Development of science technology (2200 million yen). Life Science research project (255 million yen). R&D Corporation Of Japan research (3386 million yen).

PROTEIN ENGINEERING

The Japan Key Technology Center is providing funding for the Protein Engineering Research Institute. Under. the guidance of MITI the research institute is to receive the equivalent of 1125 million (at present exchange rates) to conduct basic research for a period of 8-10 years. Differing from genetic engineering, which strives to produce existing substances such as insulin, protein engineering works to produce totally new substances which hare never existed before, such as. new enzymes

GENETIC ENGINEERING.

In October, 1986 the Ministry of International Trade and Industry approved applications for the comnercial production of amino acids and enzymes using genetic engineering from eight Japanese companies, including Kyowa Hakko Kogyo, Takara Shuzo, Mitsubishi Petrochemicals and.Showa Denko. MITI approved the applications as they met the guidelines promulgated by the ministry in June 1986 for recombinant DNA technology. Those guidelines are not legally binding, but applications go through faster if they are met. In December 1986 the Ministry of Health and Welfare formulated guidelines for the production of pharmaceuticals on a commercial basis using genetic engineering. Henceforth drugs approved for production by the ministry will be able to use biotechnology methods for production so long as they follow the ministry's guidelines. Previously the ministry had limited blotechnology methods to laboratory testing only. The ministry's guidelines have five chapters. The first provides definitions. The second chapter sets out conditions for facilities. The third chapter requires the establishment of manufacturing safety commissions. What is good news for business is that in setting out the conditions for facilities, where micro-organisms already used in industry are utilized, it was made possible to use existing drug production facilities at levels where standards have been eased the most. Thus in most cases it will be possible to use existing equipment. It is also possible to use fermentation and extraction facilities already used in laboratory work. Thus to the extent that there is not a massive increase in production, even laboratory equipment may be used for production. Nevertheless, stricter standards are still imposed for processes using relatively new bacteria and yeasts in production.

BIOSENSORS. Japan already has biosensors being used in many practical applications, from testing blood chemical levels to monitoring fermentation processes in making beer and sake to testing how fresh a fish is. The sensors combine an organic material with an electronic meter. Together, via the monitoring of a chemical reaction set off by the organic material, the presence of other materials can be measured. At present about ten Japanese companies manufacture biosensor devices with the largest sectors being in the medical fields and industrial processes. In terms of research and development, more than 50 companies and five government ministries are conducting biosensor research. Many believe that the market for biosensors will reach $1 billion by 1995. Although most of the basic research in this field has been made in the US and the UK, and indeed they are still believed to be in the lead, in the area of commercial applications it is the Japanese that are running away with the market. Even then, the government is eagerly increasing support for research with assistance coming from MITI, the Ministry of Agriculture and Forestry, the Miniistry of Education, and several government research Institutes.

BIOCHIPS. Biochips will involve`the use of proteins to create information processing systems working in much the way that living brains perform. Some Japanese companies have found that some proteins can replace some metals in semiconductors and they plan to market such devices in a few years. But the true development of biochlps is still believed many years away. True biochips would use various biological functions such as energy conversion, light sensing. memory and recognition to be more than 100,000 times more powerful than the presently most advanced semiconductors. The Japanese government is now planning to base its sixth generation supercomputer around biochips. In line with these development efforts, an advisory body to the Ministry of International Trade and Industry, the Industrial Technology Council, has recomnended that eight Japanese companies (Matsushita Electric Industrial. Sharp, Sanyo Electric. NEC. Hitachi. Fujitsu, Mitsubishi Chemical Industries and Mitsubishi Electric) form a consortium to develop such chips; In addition, the Agency of Industrial Science and Technology, a MITI affiliate will provide 5 billion yen in government funds over a period of ten years to push the effort. The group is to study how data is processed in the nervous system of lower orders of animals and the application of this to algorithms and the development of elements into which are built genes which can handle light and other signals.

THE JAPAN LAWLETTER. January 1987. By Roderick Seeman