News & Comment

For years scientists have dreamed of cleaning up the environment and eliminating pollution by genetic engineering of microorganisms. They have made some progress, but serious technical and regulatory obstacles stand in their way. Because the outlook for profits is not encouraging, industry is showing little enthusiasm for substantial development of microbial pollution control.

Patterns of biotechnology financing have undergone subtle shifts in recent months, and the shifts are an indication that the industry is moving from childhood into adolescence. Once the central source of support for U.S. biotechnology, venture capital has become somewhat less important, while tax-saving R&D limited partnerships are on the rise, and the trickle of public stock offerings has become a torrent. Around the world, but especially in Europe, governments are encouraging indigenous efforts in biotechnology. Many are backing up their encouragement with cash.

DNA probes are today's most sophisticated and sensitive technology for identifying genes. Recent technological advances are opening new commercial avenues in diagnosing infectious diseases, identifying food contaminants, and engineering genes. Industrial researchers expect to market half a dozen DNA probe diagnostics during the next year. With Wall Street analysts predicting that probes will be next biotechnology glamour child, the tests may garner substantial shares of several lucrative markets.

Biogen, perhaps the most international and certainly one of the most successful of the biotech specialist firms, is trying to graduate from a research corporation into a pharmaceutical manufacturer and marketer. Its recent public offering was designed to propel the company into this new stage by expanding its clinical testing program and building production facilities. With only one small-volume product on the market, and facing fierce competition from both the established pharmaceutical multinationals and the research-oriented gene splicing companies, Biogen struggles to position itself for the future.

Blood clots are the major cause of disabling diseases and death in the U.S. and Europe. If a clot cuts off blood flow to the heart it results in a heart attack. If blood flow to part of the brain is eliminated, a stroke occurs. And if a clot lodges between the heart and the lungs, it results in a pulmonary embolism. Medical researchers have now isolated a group of biological compounds that destroys dangerous blood clots by harnessing the body's natural clot-dissolving system. High manufacturing costs and major production problems make it difficult for pharmaceutical companies to effectively market these substances, known as plasminogen activators. But a variety of biotechnological techniques may soon increase the supply and variety of available PAs. Commercialization of these techniques should result in an effective set of new blood treatment drugs that can be manufactured and marketed at a fraction of current costs.

Government oversight of genetic engineering in the U.S. is on the verge of shifting its concerns from safety in experimentation to areas such as gene therapy and other uses that affect humans directly. To the relief of industrial observers, this oversight will probably focus on clinical applications rather than the manufacturing of substances. Few similiar signs are apparent elsewhere, but other countries are keeping an eye on U.S. developments. Around the world, the trend toward relaxation of regulation continues.

Biotechnology is widely known to be a focus of interest in the pharmaceutical and diagnostics industries, but other industries are also investigating biotechnology's potential in some of the more esoteric areas. Although only one U.S. specialty company is now concentrating on application of biotechnology to the mining and metals industry—in contrast to the 150 or more new biotechnical companies specializing in medical or laboratory R&D—several major mining and metals companies are exploring potentially useful applications of microbial and genetic engineering techniques.

Liposomes were once touted as membranous “magic bullets” that would be modern, all-purpose carriers for drugs, enzymes, and genetic material. While this overoptimistic appraisal led to disappointment, researchers have found new applications for liposome technology and new ways to engineer liposomes to perform specific functions. These applications have attracted investment in several liposome-based companies and in research programs at multinational pharmaceutical houses. A number of liposome-based diagnostic, therapeutic, and veterinary products will soon face the test of the marketplace. Meanwhile, promising research results indicate that highly focused R&D programs could lead to a new generation of immune stimulants and anti-cancer agents based upon the liposome's ability to stimulate cellular processes.

Commercialization of monoclonal antibodies may be the biotechnology success story of the 1980s. While most products of genetic engineering are still characterized as having potential or hypothetical commercial applications, there are at least 30 monoclonal antibody-based products on the market now. Hybritech, a California biotechnology firm, leads the field in production and marketing of new applications for monoclonal antibodies.

The new Congress is taking a long, hard look at biotechnology. A number of proposals will be debated in committee rooms and on the floors of the House and Senate this year, proposals which could have important effects upon the negotiation, funding, and commercialization of biotechnology research.

While many of the leaders in the chemical and pharmaceutical industries rushed to invest in biotechnology over the past decade, W. R. Grace seemed to sit idle. But now that the multinationals have completed their first round of investments at top dollar and biotechnology novices have begun feeling the pain of long-term research financing, the sleeping giant seems to have awakened.