By THOM SENZEE Contributing Reporter According to Wikipedia, biotechnology is technology based on biology, especially when used in agriculture, food science, and medicine. The online open-source encyclopedia of everything also cites the United Nations Convention on Biological Diversity, which defines biotechnology as “any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use.” But the very fact that an article about the definition of biotech warrants inclusion in this special report rightly indicates that there is some ambiguity in terms of the final answer to the question: What is biotech? “I would define biotechnology in the broadest sense as the use of cells, tissues, or micro-organisms (or their parts) to produce a desired product (food, drug, chemical, etc.), or the deliberate manipulation of the characteristics of a living organism to enhance its utility to man,” says John Philo, PhD. Philo is vice president and director of biophysical chemistry at Alliance Protein Laboratories (APL) in Camarillo. He says his definition means the making of wine and cheese and the leavening of bread with yeast could be considered biotechnology. “Starting in the 1970’s biotech increasingly came to mean large-scale commercial methods based on laboratory research techniques such as genetic engineering and cell culture,” Philo said. “The production of drugs by genetic engineering of bacteria or mammalian cells is classic biotech in that context.” Furthermore, he says, today biotech also encompasses gene therapy, individualized production of skin grafts for burn victims and individualized cancer vaccines, as well as the cloning of livestock, and much more. But another local biotech executive-scientist describes his industry more narrowly. In fact, Greg Cauchon, PhD., founder of Designed Polymers, Inc. of Thousand Oaks specifically excludes wine and bread from his biotech menu. “Biotechnology implies to me the manipulation of genetic information to coax living organisms to achieve a human purpose,” Cauchon says. “Describing it this way excludes such ancient and honorable traditions as bread-making and the fermenting of alcoholic beverages.” To Cauchon, however, the term biotechnology encompasses more modern practices such as, “expressing large quantities of proteins through the use of recombinant genetics.” The future definition of biotechnology, or more precisely the inventions that will shape its future definition, is what really matters, says Cauchon, who’s company provides analytic services to biotech firms along the 101 Biotech Corridor and around the world. ” This century is expected to usher in an explosion of exciting new biotech products ranging from medical devices, electronics, and nanotechnology to green-tech and environmental science,” Cauchon says. Wider definitions As Greg Cauchon’s comments indicate, many include more than drugs for treating diseases in their definitions of biotech. Companies like Kythera Biopharmaceuticals, of Westlake Village are already reinventing the still-young biotech industry. Kythera uses microbiology for the purpose of developing aesthetic, (i.e., beauty) products. Kythera’s CEO, Dr. Keith Leonard, says the term biotech can also include references to non-biological products, such as medical devices. In fact, he says, some modern medical devices are more akin to biotechnology than are traditional pharmaceutical drugs. “I think of biotech as very different from pharmaceuticals, which tend to be chemistry-based and very search-based,” Leonard says. “In pharmaceuticals we tend to bang a lot of chemicals against it and see what makes our model move.” Leonard believes biotech is closer to pure science. “It’s more fundamentally science driven. So let’s understand the biology really well and then understand, hopefully in an even more natural way, by mimicking the body’s own proteins or antibodies, perturb a very particular and well-understood pathway to block a disease or create a particular phenotype.” Leonard describes conventional pharmaceuticals as more of a shotgun approach to medical treatment as compared to biotechnology even in comparison to some devices. “Now there are a lot of devices, because of the nature of what they are trying to do, that are incorporating a kind of biotechnology approach, which is starting with the biology first and then understanding very elegantly ‘where can I go in with a piece of equipment instead of a drug,'” But science is not the only definer of biotech today. Money is also shaping what people think of as the biotech industry. Brent Reinke, founder of The Biotech Forum, a regional biotech business and networking group, believes investors looking to make money in biotech are broadening the term with their attentions and dollars. “It’s a lot more difficult to develop a true pharmaceutical-drug development company than a medical device maker,” Reinke says. “And it’s an easier timeline with medical devices. It’s a shorter time frame from creation, to regulatory approval, to liquidity from an investor’s point of view.” And, he says, there are plenty of investors wanting to put their money into biotech. By including medical devices, and, in some cases, even support services such as data management, and laboratory services, in the overall biotech category the door is open wider for growing the biotech industry along the Conejo Valley’s “DNA Highway” along the 101 Corridor. However, like Greg Cauchon, Reinke believes there is a more important question about definition that comes to mind when he hears the word biotech. Reinke is concerned about what characteristics will come to define the 101 Biotech Corridor itself a few years from now, especially with the recent laying off of more than 700 scientists from mega-biotech firm, Amgen. Will it stay a small cluster of biotech companies, or will it grow toward parity with Northern California’s and New England’s sprawling life-sciences (a term Reinke and many others prefer to biotech) industries? “How many places in the world have an Amgen right in their backyards?” Reinke asks rhetorically. “How many times do you have 700 people coming out of Amgen at once; it may never happen again. We’ve got a window of opportunity in the next 12 to 18 months to gain some traction and get some of these companies funded and make the next Amgen happen right here again.” On the other end of the spectrum of definitions for the term biotech is that of Dr. Tsutomu Arakawa (PhD). “Once genes are cloned from cells, they can be purified from the cells or chemically synthesized,” says Arakawa, who is president of APL. “These genes are then transfected into appropriate cells depending on the need, leading to expression of corresponding proteins. “Any study and business arising from the manipulation of the transfected cells or cells expressing the proteins are defined as biotechnology. For example, purified proteins are used as therapeutic proteins. The transfected cells are used for assay to screen drugs,” Arakawa further explains. His definition, while technically in harmony with that of his colleague, stands in stark contrast to the tone of Philo’s definition, who helps run the same company he and Arakawa co-founded. Philo’s description of the field of biotechnology borders on poetic, while Arakawa’s definition would sound purely technical to the average layperson. So where can one turn to for the definition of biotech, and why does it matter? Going back to the United Nations Convention on Biological Diversity reveals that defining biotech could, in theory, effect the very survival of humanity. The Convention on Biological Diversity (CBD) lays out multiple protocols relating to transportation of biologically dangerous materials, preventing bioterrorism, protecting vulnerable socio-economic groups from unethical experimentation and biological pollution, and numerous other so-called biosafety issues. The CBD is an evolving document (sometimes referred to as the Cartagena Protocols, in recognition of the Colombian city where the first CBD conference was held) with a growing number of signatory states, including most of the major powers of Europe, as well as China and India. The U.S. is not currently a signatory of the protocols. But in order for the specific protections of the CBD to be asserted, there must be a clear definition of what is, among other things, biotechnology. As a biotech leader some say the biotech leader Amgen’s mission statement is perhaps the simplest, most altruistic definition of the purpose of biotech: “To serve patients.” Amgen’s definition That is Amgen’s mission statement. The definition of biotech, which the company supplied to the Business Journal is this: “Simply defined, biotechnology is any technology that relies on living organisms or biological systems to make products. By this definition, human beings have been using biotechnology for thousands of years to produce food products, textiles and other necessary items. Several familiar items including yeast-rising bread, yogurt, cheese, wine, beer and vinegar are all produced with the help of cultured microorganisms.” It was the advent of recombinant DNA during the 1970s that first opened the door for gene-based therapies. Recombinant DNA refers to the practice of using genes from one organism to benefit another. Whether one has a broad or narrow definition of biotech, the “etymology” of its science is recombinant DNA. The responses to the question “what is biotech?” given by the scientists and executives interviewed for this article came in a sort of binary manner when compared one from another. Half were narrow definitions, while the other half were broad definitions of biotechnology. Also, half of the answers were highly technical, while the other half was downright philosophical. In the case of one scientist, Designed Polymers’ Cauchon, we were given a technical definition as noted above, as well as some circumspect commentary about biotech’s long-term impact on humanity. “One day our descendants will look back at the latter half of the twentieth century as just the prelude to an enormous revolution in the way we think about ourselves and our world,” Cauchon said. That, he says, is biotech.
