Learning Outcomes Describe the science of biotechnology and identify its product domains Give examples of careers and job responsibilities associated with biotechnology Outline the steps in producing and delivering a product made through recombinant DNA technology Describe how scientific methodologies are used to conduct experiments and develop products Apply the strategy for values clarification to bioethical issues
1.1 Defining Biotechnology Biotechnology is defined as the study and manipulation of living things or their component molecules, cells, tissues, or organs.
Vocabulary• Insulin – a protein that facilitates the uptake of sugar into cells from the blood• DNA – abbreviation for deoxyribonucleic acid, a double-stranded helical molecule that stores genetic information for the production of all of an organism’s proteins• Recombinant DNA (rDNA) technology – cutting and recombining DNA molecules• Polymerase chain reaction (PCR) – a technique that involves copying short pieces of DNA and then making millions of copies in a short time• Cloning – method of asexual reproduction that produces identical organisms• Fermentation – a process by which, in an oxygen-deprived environment, a cell converts sugar into lactic acid or ethanol to create energy• Diabetes – a disorder affecting the uptake of sugar by cells, due to inadequate insulin production or ineffective use of insulin• Proteases – proteins whose function is to break down other proteins• Antibodies – proteins developed by the immune system that recognize specific molecules (antigens)• Pharmaceutical – relating to drugs developed for medical use
Biotechnology Workers and the Biotechnology Workplace• Biotechnology Companies - goal is to produce and sell commercial “for-profit” products• Universities and Government Labs - conduct “pure science” research, nonprofit• Growth in the Biotechnology Industry
Domains of Biotechnology. The major domains of biotechnology include 1) industrialand environmental; 2) medical/pharmaceutical; 3) agricultural; and 4) diagnostic/research
Looking Ahead Science and Business of Biotechnology Basic Biology and Chemistry Concepts Recombinant Protein Product Applications of Biotechnology in Agriculture and Pharmaceuticals Recent Advances in Biotechnology
Vocabulary• Research and development (R&D) – refers to the early stages in product development that include discovery of the structure and function of a potential product and initial small- scale production• Pure science – scientific research whose main purpose is to enrich the scientific knowledge base• Virus – a particle containing a protein coat and genetic materials (either DNA or RNA) that is not living and requires a host to replicate• Applied science – the practice of utilizing scientific knowledge for practical purposes, including the manufacture of a product• NIH – abbreviation for National Institutes of Health; the federal agency that funds and conducts biomedical research• CDC – abbreviation for Centers for Disease Control and Prevention; national research center for developing and applying disease prevention and control, environmental health, and health promotion and education activities to improve public health• DNA fingerprinting – an experimental technique that is commonly used to identify individuals by distinguishing their unique DNA code
1.1 Review Questions1. What is biotechnology?2. Name a biotechnology product that has a medical use.3. Besides biotechnology companies, where can biotechnologists work?4. Biotechnology companies are grouped into four categories based on the products they make and sell. Name the four categories of products.
1.2 The Increasing Variety of Biotechnology Products In the past 100 years, scientists have increased the pace of searching for products that improve the quality of life. • Antibiotics • Industrial products such as rubber, turpentine, and maple syrupBioengineered ProductsAs the methods of manipulating living things havebecome more sophisticated, the number andvariety of biological products have increased at anincredible rate.
Genetically modified organisms – organisms that contain DNA from another organismand produce new proteins encoded on the acquired DNA Gene Engineered Plant. Scientists have learned how to genes that code for certain traits and transfer them from one species to another. The organism that gets the new genes will then have the potential to express the new traits coded in the newly acquired genes.
Producing GeneticallyEngineered t-PA. Humansmake only a small amount ofhuman tissue plasminogenactivator (t-PA) naturally. Bygenetically modifying Chinesehamster ovary (CHO) cells,scientists can make large amountsof t-PA for therapeutic purposes,such as to clear blood vessels inthe event of a heart attack orstroke.
The Human Genome Project• Determining the human DNA sequence• Understanding the function of the human genetic code• Identifying all of the genes• Determining their functions• Understanding how and when genes are turned on and off throughout the lifetime of an individual
Vocabulary• Antibiotics – molecular agents derived from fungi and/or bacteria that impede the growth and survival of some other microorganisms• Restriction enzyme – enzyme that cuts DNA at a specific nucleotide sequence• DNA ligase – an enzyme that binds together disconnected strands of a DNA molecule• Recombinant DNA – DNA created by combining DNA from two or more sources• Genetically modified organisms – organisms that contain DNA from another organism and produce new proteins encoded on the acquired DNA• E. coli – a rod-shaped bacterium native to the intestines of mammals; commonly used in genetics and biotechnology
1.2 Review Questions1. Name two antibiotics used as medicines.2. The use of what kind of enzymes allows scientists to cut and paste pieces of DNA together to form recombinant DNA?3. Explain how making human tissue plasminogen activator (t-PA) in Chinese hamster ovary (CHO) cells is an example of genetic engineering.
1.3 How Companies Select Products to ManufactureEach biotechnology company usually specializes in a group of similarproducts• Plant products• Fermentation equipment• Viral therapies• DNA sequencers for research• Enzymes for food processingDeveloping Ideas for New ProductsIdeas come from many sources:• Discussions lead to new ideas• Reading literature reviews can lead to new ideas• Sometimes even daydreaming can lead to new ideas
Research and Development Vocabulary• Reagent – chemical used in an experiment• Efficacy – the ability to yield a desired result or demonstrate that a product does what it claims to do• Large-scale production – the manufacture of large volumes of a product• Clinical trials – a strict series of tests that evaluates the effectiveness and safety of a medical treatment in humans• FDA – abbreviation for the Food and Drug Administration; the federal agency that regulates the use and production of food, feed, food additives, veterinary drugs, human drugs, and medical devices• Cystic fibrosis (CF) – genetic disorder that clogs the respiratory and digestive systems with mucus• Therapeutic – an agent that is used to treat diseases or disorders• EPA – abbreviation for the Environmental Protection Agency; the federal agency that enforces environmental laws including the use and production of microorganisms, herbicides, pesticides, and genetically modified microorganisms• USDA – abbreviation for United States Department of Agriculture; the federal agency that regulates the use and production of plants, plant products, plant tests, veterinary supplies and medications, and genetically modified plants and animals
A Product Development PlanBefore going into research and development, company officials mustdetermine whether or not it is worth the investment of company resources.Product Development Plan usually includes the following criteria:• Does the product meet a critical need? Who will use the product?• Is the market large enough to produce enough sales? How many customers are there?• Do preliminary data support that the product will work? Will the product do what the company claims?• Can patent protection be secured? Can the company prevent other companies from producing it?• Can the company make a profit on the product? How much will it cost to make it? How much can it be sold for?Situations That End Product Development• Product development is stopped if testing shows the product is not effective.• When this happens, companies can lose millions of dollars and years of research and development time.
Regulations Governing Product DevelopmentNew Biotech DrugApprovals. Even withall the governmentregulations, thenumber of new drugsapproved for marketincreased nearly seventimes in the 10 yearsbetween 1990 and2000.
1.3 Review Questions1. What group of potential products must be tested in clinical trials before it can be marketed?2. A drug discovery process can take nearly 15 years. Explain why it takes so long to bring a new drug to market.3. Which questions must be answered to the satisfaction of company officials before a product goes into research and then into development?4. Does every product in research and development make it to market? Yes or no? Why?
1.4 Doing Biotechnology: Scientific Methodology in a Research Facility Students are often taught that there is a “scientific method.”Conducting an Experiment Using Scientific Methodologies1. State a testable scientific question or problem based on some information or observation.2. Develop a testable hypothesis.3. Plan a valid experiment.4. Conduct the outlined experiment and collect and organize the data into tables, charts, graphs, or graphics.5. Formulate a conclusion based on experimental data and error analysis.
Develop a testable hypothesis Diluting Bleach Hypothesis. Higher concentrations of bleach should cause more color fading.
Data Table and Graph. Observationsand measurements are reported in datatable. Individual trials (replications) aswell as averages are shown. Numericaldata are shown in picture form usinggraphs.
Sharing Experimental Results with the Scientific Community Once an experiment is complete, the work is reported to others through: • Publications • Presentations • Annual conferences
Vocabulary• Data – information gathered from experimentation• Hypothesis – an educated guess to answer scientific question; should be testable• Variable – anything that can vary in an experiment; the independent variable is tested in an experiment to see its effect on dependent variables• Control – experimental trial added to an experiment to ensure that the experiment was run properly; see positive control and negative control• Positive control – a group of data that will give predictable positive results• Negative control – a group of data that will give predictable negative results• Concentration – the amount of a substance as a proportion of another substance; usually how much mass in some amount of volume• Journals – scientific periodicals or magazines in which scientists publish their experimental work, findings, or conclusions
1.4 Review Questions1. Scientific methods used by scientists vary from lab to lab and situation to situation. One approach to scientific studies is to follow a five-step process in which a question is asked and answered. Outline these five steps.2. Why do valid experiments contain many trials repeating the same version of an experiment?3. In a conclusion, evidence for statements must be given. Describe the kind if evidence that is given in a conclusion statement.4. Name two ways that scientists share their experimental results with other scientists.
1.5 Careers in the Biotechnology Industry • One of the fastest growing commercial industries • Career opportunities in: • Bioscience • Medical • Agricultural • Environmental • Applied chemistry • Physics • Computer science • Industry will be studying DNA sequence for most of the 21st century
Educational Requirements Nonscientific Positions and• Bachelor of Science Degree Educational Requirements • Biochemistry • Molecular biology Employees in nonscientific positions must have • Genetics an interest in and understanding of the science• 2-year college degree of biotechnology.• High school specialization • Sales• More advanced degrees • Marketing • Master of Science • Regulatory • Master of Arts • Legal • Doctor of Philosophy • Financial • Postdoctoral research experience • Human resources • Administrative staff
Categories of Biotechnology Jobs• Scientific Positions • Research and Development • Manufacturing and Production • Clinical Research • Quality Control• Nonscientific Positions • Information Systems • Marketing and Sales • Regulatory Affairs • Administration/Legal Affairs
Vocabulary• Genome – one entire set of an organism’s genetic material (from a single cell)• Biochemistry – the study of the chemical reactions occurring in living things• Molecular biology – the study of molecules that are found in cells• Genetics – the study of genes and how they are inherited and expressed
1.5 Review Questions1. For which types of biotechnology employees is there currently a large demand? What are the educational requirements for these types of employees?2. Scientific positions in most biotechnology companies fall into one of four categories. List them.3. Why might having laboratory experience be a benefit for a nonscientific employee at a biotechnology company?
1.6 Biotechnology with a Conscience - Bioethics• How do we learn what is right and wrong behavior?• As new situations arise in your life, how do you decide what is acceptable behavior and what is unacceptable?• How do you decide what is fair and just?Moral Standards• Being able to distinguish between right and wrong and to make decisions based on that knowledge is considered “having good morals.”• The study of moral standards and how they affect conduct is called ethics.• New technologies generate ethical questions that cannot be answered using scientific methods.• Products are regulated by FDA, USDA, and EPA.
Strategy for Values Clarification• Identify and understand the problem or issue. Learn as much as possible about the issue.• List all possible solutions to the issue.• Identify the pros and cons of adopting each solution. Examine the consequences of adopting one solution (or position) as opposed to another. Consider legal, financial, medical, personal, social, and environmental aspects.• Based on the pros and cons for each solution, rank all solutions from best to worst.• Decide if the problem is important enough to take a position. If it is, decide what your position is and be prepared to describe and defend it.
1.6 Review Questions1. Define the term “bioethics.”2. Give an example of an event that might lead a lab employee to be faced with an ethical issue.3. Describe how the Strategy for Values Clarification can be used to solve a problem such as the use of embryonic stem cells for basic research.