Biotechnology: Good or Bad? PDF

Chapter 1 1 What Is Biotechnology? B i o e t h i c s Have you ever eaten yogurt, done laundry, worn contact lenses, B i o t e c h n o l o g y : G o o d o r B a d ?...

Chapter 1 1 What Is Biotechnology? B i o e t h i c s Have you ever eaten yogurt, done laundry, worn contact lenses, B i o t e c h n o l o g y : G o o d o r B a d ? written on paper, or eaten a puffed corn snack? If so, you have used products of biotechnology. Biotechnology, in its broadest Biotechnology is powerful. It can change the genetic makeup of sense, is technology based on biology (see Figure 1.1). organisms including humans. Because of this power, biotechnology Biotechnology seems to be a modern phenomenon; however, is controversial and anti-biotechnology sentiment is common. thousands of years ago humans were applying technology to living Anti-biotechnology activists argue that biotechnology is against things by employing selective breeding to improve yield in plants nature and that biotechnologists may misuse their power. Opponents and utilizing microbes to make yogurt, bread, and wine. A timeline of biotechnology also express concern that biotechnology companies is shown in Figure 1.2 that demonstrates the rapid expansion of consider their profits before taking into account the impact of their biotechnology in the last 150 years. technology on the planet and on human life. Some concerns are unfounded and based on fear rather than scientific data, for example Bi-o-tech-nol-ogy: Any technological application that uses that genetically modified food will genetically modify the person biological systems, living organisms, or derivatives thereof, to eating it. However, biotechnology has real ethical implications that make or modify products or processes for specific use. should be considered in the context of real scientific data. Figure 1.1. Definition of biotechnology from the United Nations Convention on Biological Diversity in 1992. This definition was expanded in 2003. Biotechnologists themselves appreciate the power of the technology. When the implications of DNA technology first became evident, the Nowadays, biotechnology is considered separate from traditional National Academy of the Sciences organized a conference in Asilomar, animal breeding, plant selection, and traditional fermentation. CA, in 1975. The participants drew up principles and guidelines for Biotechnology is the use of modern molecular and microbial conducting recombinant DNA experiments to minimize biohazards techniques to make useful products or processes. There is no that are generated during the experiments. The conference organizers definitive definition of biotechnology since it is constantly also brought the implications of the technology into the public changing; however, a thorough definition of biotechnology was domain to encourage discussion. Today, the ethical implications of new technologies are still central to all scientific discussion. provided by the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (2003), an international treaty Where would you draw the line? Would you accept cancer therapy with on biotechnology. In the treaty, modern biotechnology is defined as the application of techniques "that overcome natural a drug made from a genetically engineered virus? Would you drink milk from a cow treated with a recombinant growth hormone? Would you physiological reproductive or recombination barriers and that are eat genetically modified fish? Would you clone your pet? Would you not techniques used in traditional breeding and selection." These techniques include "in vitro nucleic acid techniques, such as genetically modify a pre-implantation embryo to fix a genetic disease? Would you clone yourself? Consider these questions as you learn more recombinant DNA or direct introduction of nucleic acid into cells about the power of biotechnology. Use the knowledge you gain in this or organelles, or the fusion of cells beyond the taxonomic family." course to make informed decisions in your personal and professional life. Biotechnology is not a pure scientific discipline. It draws on COUNTERTHINK "FISHING FOR GM SALMON" knowledge and techniques from many of the biological sciences, such as genetics, molecular biology, biochemistry, cell biology, and microbiology (see Figure 1.3). Biotechnology also draws on many nonbiological fields of study, such as engineering, chemistry, physics, and information technology. Conversely, many of these GH disciplines also draw on the methods that biotechnology has developed (see Figure 1.4). Biotechnology is distinguished from other biological disciplines by its purpose to develop products and processes. Because commercial products are created by the biotechnology industry, biotechnology makes a direct contribution to the world's economy. The Biotechnology Toolkit Biotechnology is fundamentally a set of tools comprised of a series of techniques that can help solve a multitude of problems. These tools can be biological, chemical, instrumentation, or software. Biotechnology companies such as Bio-Rad Laboratories are in the business of making new and better tools and techniques for researchers and businesses. CHAPTER 1: THE BIOTECHNOLOGY INDUSTRY 3  1 Chapter 1 Chapter 1 Virology Microbiology 1 Chapter Many tools use whole cells or molecules, such as DNA RNA, Who Uses Biotechnology? Basic life science research and proteins that are derived from nature. Scientists modity these Blochemistry Molecular biology cells and molecules to perform new tasks. Chemistry is also Biotechnology is used by many different industnes and scientific important in biotechnology since many tooks rely on chemical Nanotechnology Human origins Cell biology disciplines (see Figure 14). Currently the main users of interactions. Laboratory instruments are used to pertorm and Genetics biotechnology are the life science research, health care. analyze biotechnological procedures and products. Advances in agncultural, food, and manufacturing industries Biotechnology is Forensics Agriculture biotechnological techniques are frequently made by finding new Bloinformatics also important in national defense, research into human ongins ways to use or improve existing tools. The actvities in this book Bioengineering (anthropology), forensics, and nanotechnology will introduce you to many of the tools and techniques used Mining Food in biotechnology. Life Science Research The dividing line between basic life science research and Biotechnology Biological tools include enzymes that cut and reattach DNA. These Biofuels Health care enzymes allow scientists to transfer DNA from one organism to biotechnology research is hazy. Basic life science research is Nanotechnology Chemistry another so that the recipient organism can perform a new and driven by curiosity to understand more about ife. The goal of basic useful task. For example, the human insulin gene was cut out of research is to understand how a system worksThe goal of Biodefense Conservation the human genome and inserted into bacteria to give the bacteria Physics Engineering biotechnology research is to develop something to help solve a the ability to make human insulin. The insulin was subsequently problem; this type of research is called applied research For Pollution monitoring Waste management puntied and is now used as a therapy for diabetes. The process of example, if a new virus that infects humans is discovered, basic moving a gene from one organism and expressing it in another is research scientists would investigate the normal mode of action of called genetic engineering. Genetically engineered bactena and the virus, its nucleic acid sequence, and the proteins that are Industrial manufacturing eukaryotic cells are biological tools that are frequently used as Four 13 Scientill disciplings that contributo so biotechnology rea important for its virulence Applied scientists would take that ores represent botagical scenes and gray banes represent other scente Figure 1 4 Where biotechnology is used factories to produce novel proteins (recombinant proteins). desapines. information and develop drugs and a vaccine to combat the virus Chemical tools include chromatography resins that bind light absorbed by a solution and are used to quantilate bactena Basic life science researchers use many biotechnological tools and approach to life science research. This shift to systems biology on proteins based on particular properties of the proteins, allowing proteins, and DNA. Thermal cyclers rapidly heat and cool tubes techniques in their investigations, and many biotechnological tools the molecular level has become possible only because them to be punfied from other cellular components. For example. or DNA and enzymes, thereby enabling rapid DNA replication by a and techniques are based their discovenes. These tools include cell advances in the biotechnology toolkit available to researchers The chromatography resins are used by pharmaceutical companies to culture and cell expression techniques to understand how cells disciplines using this approach have been termed "-omics" technique called the polymerase chain reaction (PCR). Among purity biological drugs produced in bactena. many other applications, PCR is used in forensic laboratones to function, grow, divide, and die. Researchers also use recombinant fingerprint DNA. DNA techniques to discover how genes and proteins function. ? Genomics investigates the whole genome, the full Biotechnology relies on many instruments that differ based on the complement of DNA in a cell application. Some instruments measure, while other instruments -Omics and Systems Biology Proteomics studies the proteome, the entire proter Biotechnological tools and techniquesa r e constantly bang perform a function. Spectrophotometers measure the amount of There has been a shift in life science research from studying how complement of a cell or organism improved and applied in new and exciting ways to help solve the a single gene or protein functions to investigating how whole cells, Transcriptomics is the study of the transcoptome, every problems of mankind. organisms, populations, or ecosystems function on the molecular RNA transchpt expressed in a cell or organism level.The term "systems biology" is used to describe this ? Metabolomics investigates the metabolome, all metabolites in a cell or organism present at a specific time The lives are thoi 1980: The US Supreme Cour approves The precede el Detenting in orgarten. somatotman UBST, worded menas Pusher on dary cous son, one, an o per en to norease products, coates Doty the sheep the test arenad 2003: (axf13): txe frst transpean, Rs. - 1280: CHYmanno, MAX anchanno envymeasusers the frit lo pruders of capto crope we grown by tarmers lor cutt 1006 on a men canca a mocked 1908. First lets crop vida of tentacto restone genercely 1090: The Hurren Genrema Profect sotarco) in the US and France wees in the US tood nestry ? 1998. 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Timeline of biotechnology. 1 H O 0 1080 1990 8000 2010 A BIOTECHNOLOGY: A LABORATORY SKILLS COURSE CHAPTER 1 THE BIOTECHNOLOGY INDUSTRY  Chapter 1 The theory behind systems biology is that the reaction of a cell. the drugs work as expected mas are laborainals may be vin organism, or ecosystem to an input (for example, a drug therapy) can be predicted only when all these factors have been taken into account. bee beenhad the expression genetical resen of aofgene ass the drug as or genes tireen i gen an Transgenic animals may express the hug tan it o may hat th Each of these -omics generates vast amounts of data,and one of the major challenges of the 21" century will be finding ways to sort and analyze these data. Using information technology specialy animals date again during ang at development. drug oleg do ped during development drag work Precia an ose besting song do ate.it andean. an for biological applications is called bioinformatics. Bioinformatics is a rapidly growing area of biotechnology. Bioinformaticians the concentration at which drugs work best an in to as find ways to gather, store, sort, and analyze data. They then use side effects. the data to make computer models to predictcellular and organismal behavior. Some drugs, like those used in chemotherapy, have serious in effects such as nay and not mut to disras i because n Health Care treat the whole biotechnology body have and not enabled thethe developense development ise. aliase. of therapis ta a Health care is the largest segment of the biotechnology industry. Currently the biotechnology companies that generate the most be delivered directly to diseased tissue and greatly reduce so revenue develop biopharmaceuticals, medical devices, and effects. For example, Rexin-G, a drug that targets parcen diagnostic tools and tests. cancer, has been developed to be delivered on paries cou nanoparticles that are nanometers in diameter. Rexin- g Biotechnology and pharmaceutical companies use biotechnology genetically engineered virus designed to seck out and i care to discover new drugs in a process called drug discovery. These cells that have metastasized or escaped the main tumor. The 1. companies also use biotechnology to develop and manufacture was so effective in clinical trials that the U.S. Food and C. drugs. Drug development is very expensive and time consuming. Administration (FDA), which regulates clinical trials, gave i spen Very few drug candidates actually make it to the market. Most status in 2010 to help speed its approval for clinical use. Rest candidates are rejected before they are tested on people in clinical is an example of nanotechnology and biotechnology test, trials. Many more are rejected during the phases of clinical trials as combined to create the emerging field of nanobiotechnology companies narrow down the best drug to combat the disease. From start to finish, it takes 10-15 years to develop a new drug Clinical Trials and costs around $800 million. This cost includes the research into A drug that has been shown to be effective during preclinical treat all the drugs that were rejected and has the potential to become a new therapeutic drug may re taken into clinical trials. Clinical trials are tests of the drug, Drug Discovery humans. Initial trials test how safe the drug is in a small, hear Drug discovery is the initial hunt for molecules that could treat a population. Later trials then test how effective the drug is agars disease. If a specific disease-causing protein needs to be the disease in actual patients. neutralized, drugsmay be developed to inhibit the protein. Alternatively, an entire network of proteins may be found to be The design of clinical trials is very important and greatly depend S involved in a disease, in which case all the proteins involved in the on the severity of the disease and on how common it is. Clinica disease become targets for drug therapy. trials are usually conducted by splitting patients randomly into tuc groups (or arms); one arm receives the drug while the othe Many biotechnology and pharmaceutical companies use high- receives a placebo (often referred to as a sugar pill) that has beer throughput tools and techniques. High throughput means that designed to mimic the actual drug. Usually neither the physicas hundreds or thousands of targets can be investigated all at once nor the patients know which treatment patients have received- rather than one by one. For example, microarrays are used to this is referred to as a double-blind study. Double-blind stuces simultaneously screen thousands of drug candidate molecules by reduce the possibility of the physicians biasing the results. binding them to a microscope slide and incubating them with the target protein. The candidates that bind to the target can be Clinical trials are conducted in at least three phases. In phase quickly identified and investigated further. small group of healthy individuals, usually fewer than 100, is gre the drug to test for safety and dosage levels, as well as Drug Development determine how the body metabolizes the drug (for example. to Once candidate molecules have been found, they need to be long the drug remains active in the blood stream), In phase l" developed into drugs in a process called drug development. Drug trial is expanded to 100 to 300 participants to investigate wher?? development often involves modifying the original drug candidates the drug helps people suffering from the disease. Phase Ill of " through chemical engineering to make them perform better. The trial is the final hurdle. During this phase, a large trial is conducte. drugs are tested in a phase called preclinical testing in which in the specific patient population, with 1,000-5,000 patter: 6 BIOTECHNOLOGY: A LABORATORY SKILLS COURSE  Chapter 1 monitored for the drug's effectiveness and side effects. In 2009, antibody-based tests may also require a medical laboratory to there were 587 phase Ill clinical trials being conducted in the U.S., have special instrumentation. Laboratory tests can determine the the majority of which were for cancer therapies. actual level of a protein (or multiple proteins) that may change when someone has a certain medical condition, which helps Personalized Medicine diagnose the stage, or seriousness of the condition. Figure 1.5 A new era in personalized medicine, or pharmacogenomics shows a dipstick test that is used in a laboratory to test for HIV. (pharmaceuticals based on genomics), is revolutionizing health care. Similar to having a dentist make a cast of a patient's teeth for a retainer specifically designed for that individual, biotechnological advancements will enable patients to submit tissue samples and receive a treatment regimen designed specifically for them. Individual characteristics affect responses to drugs and determine how well the drugs work. At the present time, only research on the effectiveness of a drug based on broad characteristics, such as race/ethnicity, gender, and family history, has been performed. These factors do have an effect, and some drugs are prescribed depending on these factors. Figure 1.5. Bio-Rad's Genie II HIV1/HIV2" assay. A serum sample is added to the circular area. If the serum is HIV positive, proteins will bind to the reagents in the strip, and colored stripes will develop in the viewing zone, depending on which proteins are present. This assay works similarly to a pregnancy test. As sequencing individual human genomes becomes more cost- effective, there will soon be a time when a drug regimen is determined by the genotype of the patient or the tumor being Agriculture targeted. One of the first drugs to fit this bill is trastuzumab (trade Agriculture uses crops and animals engineered by biotechnology. name Herceptin). Herceptin works only in breast cancers that have Since 1996, genetically modified crops with properties such as a mutation that causes a specific protein, called HER2, to be pest-resistance, herbicide-resistance, and extra nutritional content produced at levels that are too high. The cancer cells are screened have been farmed to increase yields, decrease pesticide use, and to determine whether they are overexpressing HER2 before increase food value. Many of these traits are being "stacked" on patients are given the drug. The decision to administer Herceptin top of one another by interbreeding plants to produce varieties is based on a single gene. In the near future, treatments will be with multiple genetically engineered properties. For example, based on the entire genome of a patient. Smartstax corn has eight different genetically engineered traits. Clinical Diagnostics Since cultivating crops is less expensive than culturing animal cells, agricultural scientists are investigating ways to manufacture In addition to developing drugs, biotechnology is also used to therapeutic drugs in plants. For example, the biotechnology diagnose diseases and other medical conditions. Doctors' offices, hospitals, and medical laboratories often use diagnostic tests company SemBioSys has performed a phase VIl clinical trial with recombinant insulin produced from genetically engineered developed by biotechnology companies for these purposes. safflower (see Figure 1.6). If the drug passes all clinical trials, the Many diseases are caused by microorganisms such as bacteria. price of insulin will be reduced. Researchers are also genetically engineering fruit such as bananas to make vaccines that are Microbiological techniques can be used to identify the cause of an effective when the food is eaten. If such vaccines pass approval, infection, allowing the appropriate therapy to be prescribed. they will have a tremendous impact on the developing world Diagnosis of microbial infections traditionally takes days or even where many people do not have access to vaccines because of weeks since bacteria need to be cultured before they can be identified. Biotechnology has helped to speed up diagnoses. In cost, the lack of skilled personnel to administer vaccines, and the need to keep vaccines refrigerated. some cases, more specialized microbial media have been developed to identify disease-causing bacteria quickly. In other Biotechnology has affected how farmers raise livestock. cases, entirely new tests, often based on PCR or antibodies, have Agricultural scientists found that by treating dairy cows with an been developed injectable growth hormone called recombinant bovine somatotropin (rBST; brand name Posilac), they could increase Antibodies are proteins that specifically recognize and bind to milk production, which subsequently increases farmers' yields other proteins. They are commonly used in diagnostic tests to and reduces the price of milk. Advances in technology that affect identify proteins known to be indicators of medical conditions. food production need to gain consumer acceptance. For Examples of antibody-based diagnostic tests include dipstick tests example, even though scientific tests have shown no significant that are used in laboratories, doctors' offices, and occasionally by differences between milk from cows treated with rBST and non- the general public (for example, pregnancy tests). Dipstick tests rBST-treated cows, many consumers choose to buy milk from show the presence or absence of a protein involved in a medical untreated cows. Therefore, although the treatment increases condition using a urine, saliva, or blood sample. Analysis of profits, it may also decrease sales. CHAPTER 1: THE BIOTECHNOLOGY INDUSTRY 7  1 1 Cha Chapter 1 Botechnology was fest en in thing so an a to n ofyneration processes tor yogurt and hake bread. y soybeans, and curdie milk for bacteria are he se he. in the moderm era, yeast are ure mean tal engin yed of (od processing, or used to be sure importa by vas not or are wore no one on rested in decreased years eistant are no eas engine yields of ted dairya products. prenu that are restant to the wins. ross The food industry also uses biotechnolay to improve the sa or nutritional content of basic food staples. In this rests, Good industry is intimately linked to rice cultral biotechnocen example, golden rice is a type of nee that has been gree engineered to express beta-carotene, a precursor to vitar , Figure 1 6 Safflower This flower is being investigated as an alternative system to help reduce vitamin A deficiency, Vitamin A deficien lease. animal cell culture for the production of insulin. blindness in more than 250,000 children each year ri developing world. Although golden rice may seem to be a Biotechnological practices often go hand in hand with government solution to a global problem, it needs governmental acces legislation. Antibiotics were developed to treat bacterial infections, but before it can be sold for human consumption, and approgs. antibiotic-resistant bacteria are now major health care concerns. Fifty take a long time. Golden rice was developed in the laborator years ago, adding low levels of antibiotics to livestock feed was found to increase the animals' growth. This generated higher yields and 1999 but it is still navigating the governmental regulator 9p in 2010, with clearance expected in 2012. Geneticaly mos reduced the price of meat, and the practice was approved by the FDA. Now, however, there are fears that this practice is increasing the animals with added nutritional value are also being develo such as pigs with high levels of omega-3 fatty acids. As of 2 emergence of antibiotic-resistant bacteria. In 2007 and 2009, the Preservation of Antibiotics for Medical Treatment Act bill was genetically modified animals have not been approved tor introduced by U.S. senators proposing to phase out nontherapeutic use of antibiotics in animal feed. Cows and goats that express therapeutic drugs in their milk are being engineered as a less-expensive alternative to cell culture systems. This practice is termed pharming since it combines the pharmaceutical industry and the use of farm animals. Research is also being conducted into using animals to produce organs for transplant into humans. The donor animal would be humanized, which means it would express human proteins that would be liv personalized to the individual needing the transplant. This would prevent the recipient of the transplanted organ from rejecting the organ as well as negate the need for immunosuppressant drugs. Figure 1.7. Genetically modified salmon. Size comparison of an AquAda CL salmon (background) with a non-transgenic: Atlantic salmon sibling (foreground Fisheries and the aquaculture industry are also involved in same age. Photo courtesy of Aqua-Bounty Technologies. biotechnology. in 2010, controversy surrounded the FDA when it was deciding whether genetically engineered salmon could be sold to U.S. consumers. The genetically engineered salmon express growth hormones from different fish species that make them grow faster (see Figure 1.7). Many people are concerned about the impact of these fish when eaten or if they gain access to the wild. Biotechnological research is also being conducted the environments and populations of wild and farmed fish and shellfish to help conservation, management, and breeding. 8 BIOTECHNOLOGY: A LABORATORY SKILLS COURSE  Chapter 1 1 large chemical companies have joined forces with smaller biotechnology companies to find enzymes that can convert plant sugars into useful polymers to replace traditional plastics. Biological plastics have recently become competitive in price and performance with plastics made from petrochemicals. In addition, biological plastics take fewer resources and energy to produce, and reduce landfill waste because they are biodegradable. Biofuels Biotechnology is being used to develop alternative energy sources. Fossil fuels are limited and are having a detrimental effect on the environment. Plants are a renewable source of energy; however, it is difficult to harvest the energy in plants because it is stored in plant cell walls that are hard to break down. As part of the Energy Independence and Security Act, the U.S. government has dedicated billions of dollars to biofuel development. Many government laboratories are trying to find natural enzymes and to genetically engineer enzymes that can efficiently release the energy stored in plants to make a cost-effective biofuel. Mining Biotechnology has also improved yields in mineral mining. Microorganisms such as Thiobacillus ferrooxidans that get energy by oxidizing sulfur compounds and iron are being used to leach minerals such as copper from mine waste piles (tailings) or low- Figure 1.8. Ancient bakery in Pompeil. grade ore in a process called bioprocessing. The copper can be collected in solution and purified. Mining companies now generate Industrial Manufacturing 25% of the world's copper through bioprocessing. Biotechnology has helped to improve efficiency, increase yields, and reduce environmental impacts from manufacturing industries. Enzymes and microorganisms are currently being used in place of chemicals and energy-intensive processes. For example, in the textile industry, stone-washed jeans used to be washed with stones and acid, which was expensive because it damaged the, machinery. Now an enzyme called cellulase softens the denim. Using the enzyme reduces the environmental impact of the harsh chemicals and reduces the cost of the machinery. Fide Many manufacturing processes require conditions that are not COLDWATER optimal for most enzymes, such as high or low heat, high pressure, or highly acidic, alkaline, or salty conditions. However, some microorganisms thrive in seemingly harsh conditions like hot springs or salt marshes. Research into these organisms is being performed to find enzymes that can be used in traditionally non- optimal conditions. An example close to home is the development Figure 1.9. Tide Coldwater laundry detergent. of laundry detergents that work in the cold wash cycle (see Figure 1.9). These - detergents contain enzymes derived from microorganisms that thrive in cold water. As a result, the enzymes break down fat and protein stains without requiring hot water, thereby reducing the demand for energy to heat the water. Petrochemicals are used to manufacture plastics, and plastic waste creates an environmental problem because plastics do not degrade. Plant-based plastics are now being investigated and produced as a more environmentally friendly alternative. Many CHAPTER 1: THE BIOTECHNOLOGY INDUSTRY 9  Chapter 1 Monk Bio-Rad: Then and Now Bidethnology companies often star with an idea 192, group of students tom tha Oleum Bayo Vista Rodeo virus: At the time tobacco mosa vis (tAl sat, a a a de spite out, ? Hercules that founded Bio Rad Laboratores, had to take on the ta oh hak of producing the on Gateley TA which ok many days to prepare, David Schwarta to at enty graduate we a Pinole dege chemistry, questioned why no one wail one i a mate on, Sayview Montalvin he and Alice were making MV out of a Word War I Quonset hut in Berkeley, CA. Tha via the start of Bio-Rad Laboratories, Tw BIOR AD did, including chromatography resine and stable isotopes. When the compery incorporated in 1957, its annual sales were $25,000. Keeping a start-up company afloat requires wearing many hats. A photographer for Life magazine shot tre photo at left in 1955, commenting that Richmorid David Schwartz still mows the gras Central even though he was the compary president. David was responsitle for sales and marketing, and Alice developes the products. Sixty-plus years later, Bio-Rad revenues in 2009 were neatly S1.8 billion, and David and Alice Schwartz are still on the board of directors for the company, their son, Norman is the president and CEO. Photo of David Schwartz by Robert Lackenbach/Time Life Westbrae Normandy Pictures/Getty Images Village West Berkeley - Berkeley Today, Bio-Rad operates in two industry segments: clínical diagnostics and life science. Southwest - Rochedale Clue Bio-Rad's Clinical Diagnostics Group develops products for medical screening and diagnostics. Berkeley Village including products for diabetes monitoring, blood vinus testing, and genetic disorders testing Fairview The Life Science Group develops laboratory instruments, apparatus, and consumables used CrA for research. These products, which are used to separate, purity, identify, analyze, and ampity biological materials, are based on technologies such as electrophoresis, chromatography, and = Emeryville PCR (the type of equipment and reagents that will be used in this course to support life science research in universities, government laboratories, and biotechnology and pharmaceutical companies. In 1996, an educational arm of the Life Science Group, the Biotechnology Explorer W e s t Program, was started to advance biotechnology education in high schools and colleges. Campbell Oakland Village The program develops hands-on laboratory activities to teach biotechnology skills to students around the world. Oakland 12 BIOTECHNOLOGY: A LABORATORY SKILLS COURSE  Chapter 1 1 Biotechnology number: in 2009 these areas collectively boasted 622 public biotech companies, as well as many more private firms. Examples Industry and Research of large public biotechnology companies are Amgen, Gilead Sciences, and Biogen. Biotechnology companies are frequently Biotechnology emerged in the late 1970s as a distinct industry. acquired by pharmaceutical companies to infuse new technology The first products from the biotechnology industry were based and products into their portfolio. For example, one of the biggest on recombinant DNA technology: drugs manufactured by the biotechnology events in 2009 was the acquisition of Genentech by pharmaceutical industry. One of the earliest biotechnology Roche for $46 billion. companies was Genentech, which was founded in 1976. Genentech developed a process to make a drug called Humulin, a Most biotechnology companies start as private companies and then recombinant human insulin to treat diabetes that was produced "go public" through an initial public offering (IPO) once they have in bacteria. developed technologies or products that appear to have the potential to be profitable. In the U.S. there are many more privately Biotechnology companies are placed in a different business category held biotechnology companies than public companies; in 2006, there were 1,452 privately held biotechnology companies. A brand than pharmaceutical companies (referred to as big pharma), even though pharmaceutical companies use a great deal of biotechnology new biotechnology company is commonly referred to as a "start- in their business. Based on 2009 revenues, the world's largest up." Start-ups are usually very dynamic companies with highly energetic, ground-breaking teams. Employees have the potential to pharmaceutical companies were Johnson & Johnson, Pfizer, and gain experience in many different areas due to the small size of such Roche, each with revenues of around $50 billion. Medical companies. If the technology offered by a start-up is successful, biotechnology companies traditionally develop therapeutics based on biological compounds such as proteins and DNA, while big pharma there is also the opportunity to make a lot of money from stock typically develop therapeutics based on chemicals small options and bonuses. The downside is the lack of job security. molecules. However, these boundaries are becoming blurred as some biotechnology companies work on small molecule therapeutics Many Western biotechnology companies have operations in China and pharmaceutical companies work with biological compounds. The and India, where homegrown biotechnology companies are also main differences between biotechnology companies and big pharma developing, Smaller Asian countries such as Singapore are also are their business models and the way they manufacture and market heavily investing in biotechnology. In fact, there is a campus of therapeutics (see Table 1.1). Many biotechnology companies do not biomedical science research and development in Singapore called Biopolis. Biotechnology is expected to become a major part of the plan to manufacture the drugs they develop; instead, they plan to sell the drug candidate to a larger biotechnology or pharmaceutical global economy in the next decades. company that has manufacturing expertise. Funding Biotechnological Advancements Most of the world's biotechnology companiesare in the U.S., Laboratory research is expensive. There are many different ways although Europe, Canada, and Australiaalso havea significant of funding research, depending on the type of organization where the research is performed and the individuals) performing it (see Table 1.2). Table 1.1. Differences between pharmaceutical and biotechnology companies. Pharmaceutical An established company uses the profits from the products it sells Biotechnology to fund Research and Development (R&D). This practice develops Size Medium to large Start-up to medium a pipeline of products in which products that have already been launched pay for the development of new ones, which, in turn, Development Formal Innovative should eventually pay back their own development costs (this is process Expertise Chemical i Biological Table 1.2. How different organizations fund biotechnology research. Focus Drug development. Drug discovery and manufacture, and development or novel Type of Organization Funding Sources marketing technologies Large biotechnology and Profits from the sales of Industry Health care Health care and/or pharmaceutical companies existing products served many other industries Small biotechnology Venture capital and Financing Shareholders, Private investors, companies and start-ups government grants revenues shareholders Academic institutions,. Government grants and Business Low risk High risk research institutes, hospitals, other funding, foundations, approach government laboratories endowments, and charities CHAPTER 1: THE BIOTECHNOLOGY INDUSTRY 13 1 1 Chapter 1 the most appropnate species, and study the fewest number of plans deler some steam or pose the heal grate, incineration to create steam for power. animals possible to answer a specific question. The USDA, through APHIS, has set forth federal regulations governing the care and use of animals in biomedical research in the Animal Welfare Act (AWA). The AWA sets standards of care for research Perectare rome maywaste. fact amaterial even Me orenadeveloped havegentries. generate vaseducts. useful me a ene For produce ma i brames animals with regard to their housing, feeding, cleanliness, ventilation, and medical needs. It also requires the use of anesthesia or analgesic drugs for potentially painful procedures partena thatindusty, mananacturing degrade s, produce produce mean methane that nocan, can bo ea and during postoperative care. The AWA currently does not cover and used for fuel. rats and mice, which comprise more than 90% of all animals used in laboratory research. The U.S. Public Health Service (PHS) Act Regulation of Nanotechnology covers all laboratory animals in institutions that receive research funds from the NIH, the FDA, or the Centers for Disease Control. Nanotechnology thare are cumentlyand a spendi no spectice regularguding produce. an earn tha ae cona These researchers must adhere to the standards set out in the "Guide for the Care and Use of Laboratory Animals," authored by deo al of the nanoparticles ty poto the Contem not t the National Research Council of the National Academies. rassed that nanoparticles maned a special environment and heath risks. The EPA publishe informati report, ale a u Regulation of Waste Disposal past 2007 10 communicate italiano one. Agencies such as the EPA regulate how companies generate and about nanotechnology, health is vest National inste ; dispose of their waste andconduct their manufacturing Occupational Safety and Harticles investigating prete rea concerns caused by nanoparticles. processes. Each country, state, and institution has specific guidelines that should be followed for waste disposal. These r e g u l a t i o n s p r o t e c t t h eenvironment from pollutants. Workplace Safety Regulation Biotechnologygenerates different types of waste, including Working in a laboratory or brotec ot wores facturing are a nonhazardous liquid and solid waste, biohazardous waste, and be hazardous, and the safety o. Worker is regulates n toxic waste. U.S. by OSHA, part of the U.S, Department of Labor. com encourages employers to reduce workplace hazards ÷ Biohazardous waste includes any type of medical waste, such as develops mandatory job safety and hearth standards, who tissue samples, blood, cell and microbial cultures, stocks of enforced by worksite inspections. These standards incuss viruses, and sharps. Sharps are discarded medical articles such requirement that employees wear appropriate personal protest as hypodermic needles that may cause puncture wounds. Most equipment (PE), In the laboratory, PRE includes a latcas biohazardous waste is treated to kill microorganisms or infectious coat, safety glasses, and gloves. Specific dangers in a laters agents by steam sterilization (autoclaving), gas sterilization, or include hazardous chemicals and biohazards such as micre chemical disinfection such as submersion in bleach. Once cultures and blood-borne pathogens. OSHA requires that wre treated, the waste can be disposed of as nonhazardous. Sharps be trained in the safe use of hazardous materials and in gres and other waste that cannot be disposed of by these methods are laboratory safety. Businesses are aso required to keep a co, transported to specialized facilities for appropriate disposal. workplace injuries and illnesses and to show improvemens, their safety record. All employees in the U.S. have the ngt c safe workplace under the OSH Act and are protected to discrimination that might occur as a result of exercising this -gi animal any mou need a eage in he ran an in to some DNA and protein stains, acids, bases, and heavy metals (for example, mercury in thermometers). The use of radioactive materials in laboratory research is on the decline; however, radioactivity is still used in some biotechnology research and has strict guidelines regulating its use and disposal. Toxic waste may be sealed and disposed of by burying it in a hazardous waste landfill. More often, toxic waste is incinerated to destroy the toxic chemicals. Due to the high cost of disposal, companies are working to reduce the toxic waste they produce. Some industrial 16 BIOTECHNOLOGY: A LABORATORY SKILLS COURSE  Chapter 1 1 Industry Practices How To... In addition to ensuring their business practices meet government regulations, companies also voluntarily adhere to industry Write an SOP standards. Industry standards are rules established by international organizations, such as the Organisation for A standard operating procedure is a document that describes Economic Co-operation and Development or International how to complete a common task. SOPs are necessary to ensure Organization for Standardization (ISO), to ensure that products are workers comply with company policy and industrial standards. SOPs researched, developed, and manufactured correctly and are usually written on a template specific to the company. An SOP consistently. These organizations certify that business processes, should be written clearly so that it can be understood and followed practices, and products adhere to a specific set of standards by anyone expected to perform the procedure. Once drafted, an called a quality system or quality management system. Each SOP is reviewed and approved by a department manager. company voluntarily chooses the standards it will meet, and the standards organization audits the company to ensure the The header of the SOP must be present on every page of the SOP standards are being met. The quality assurance (QA) department and usually contains the SOP title and document number, the within a company ensures that it complies with the requirements author's name and department, the date of creation and approval, of its quality system. Quality systems require that records be and page numbers (see Figure 1.14). The document number allows maintained on the operations happening in the company. For the SOP to be tracked through the company's quality system. example, a laboratory notebook is a record of the research being conducted. One way companies ensure consistent business and Anyschool University Standard Operating P laboratory practices is by deciding on a single way to perform SOP. 001 common tasks or processes and writing the procedure as a Biotechnology Depl Page 1 of 2 rested: 02/11/2011 standard operating procedure (SOP), which must be followed uthor. John Smith horization. Dr. Sume by everyone who performs that task in the company. For example, the task may be a laboratory procedure or a method to calibrate Purpose T h e S u n d r e a laboratory equipment, but it may also be a general business S c o p e practice related to other departments such as customer service or 1 9 3 0 r o o e c a s u r g i o r accounting (see How To... Write an SOP at right). a d e q u a t e t r a m a n l o e r o u s c o m p a n a Additional Docum Industry standards help global business because they harmonize business practices around the world, making communication and Figure 1.14. Example of an SOP