1. Introduction to Biotechnology!

2. 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

3. Defining Biotechnology Biotechnology- the study and manipulation of living things or their component molecules, cells, tissues, or organs.

4. The beginning of biotechnology Humans have been manipulating living things for thousands of years Selective breeding- manipulating living things with desired characteristics Why? Examples?

5. Beginning of Biotechnology Over 100 breeds of dogs created through selective breeding

6. Beginning of Biotechnology Different varieties of apples commonly found in grocery stores

7. Beginning of Biotechnology Range of size, color, and fragrance for a variety of roses

8. Beginning of Biotechnology Cows, goats, sheep, and chickens for milk, meat, and egg production

9. Beginning of Biotechnology Fermentation of foods and beverages

10. The 1970’s Scientists began experimenting with molecules, cells, tissues, and organs (moving away from entire organisms). WHY? New technologies are applied to the research and development of products from plant and animal tissues The term “Biotechnology” was coined

11. Levels of Biological Organization Cells of multicellular organisms are usually grouped into functional units: –Tissues –Organs Cells are the smallest units of life. Some cells contain even smaller, nonliving units.

12. Biotechnology today Focuses on DNA Deoxyribonucleic Acid- a double- stranded helical molecule that stores genetic information for the production of all the organism’s proteins

13. The Central Dogma of Biology states that DNA codes for RNA and that RNA codes for proteins (DNA -> mRNA -> proteins). Moving genes into cells to produce new proteins is the basic principle in genetic engineering. The Central Dogma of Biology.

14. Recent uses of biotechnology Insulin- made in bacteria cells to treat diabetes Originally insulin was harvested from the pancreas of a slaughtered animal for treatment

15. Recent uses of biotechnology Proteases- proteins that break down other proteins Commonly used in stain removal products

16. Recent uses of biotechnology Antibiotics- proteins developed by the immune system that recognize a specific molecule (antigen) Used to fight diseases

17. Recent uses of biotechnology Indiage- protein (enzyme) that causes denim to fade to produce “stonewashed” appearance

18. Recent uses of Biotechnology Mouse cells “tricked” into growing outer portion of a human ear which can be surgically transferred to a human patient

19. Recent Advances in Biotechnology come from Manipulation of DNA! What do you think of when you hear this?

20. Techniques used to manipulate DNA Recombinant DNA (rDNA) technology- cutting and recombining DNA molecules E. Coli transformation

21. Techniques used to manipulate DNA Polymerase Chain Reaction (PCR)- copying short pieces of DNA Amplifies DNA sample

22. Techniques used to manipulate DNA Cloning- producing identical organisms

23. Who is practicing Biotechnology?

24. The Biotechnology Workplace  Biotechnology Companies - goal is to produce and sell commercial “for-profit” products  Staff- scientists, researchers, lab technicians, manufacturing, marketing, sales  Universities and Government Labs - conduct “pure science” research, nonprofit “pure science” research, nonprofit  Report results in scientific journals or meetings for the “public good”

25. Domains of Biotechnology. The major domains of biotechnology include 1) industrial and environmental; 2) medical/pharmaceutical; 3) agricultural; and 4) diagnostic/research

26. Government Agencies CDC 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 NIH National Institutes of Health- the federal agency that funds and conducts biomedical research

27. Other institutions DNA fingerprinting used by: –Forensic scientists within police departments to identify suspects –Ecologists to determine parentage of endangered species for breeding purposes –Wildlife biologists/customs agents to identify illegally poached or transported animals (bear gall bladders, rhinoceros horns, ivory from tusks, exotic birds) –Evolutionary biologists to determine relatedness of organisms (red panda is more closely related to the raccoon than it is to the black and white panda bear)

28. 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.” As the methods of manipulating livings have become more sophisticated, the number and variety of biological products have increased at an incredible rate

29. Techniques That Make Manipulation Possible Restriction enzymes – cuts nucleotide sequence at specific sites on DNA molecule DNA ligase – enzyme that pastes DNA molecules together allowing for new combinations Together these allow for us to make recombinant DNA molecules!

30. Techniques That Make Manipulation Possible Plasmids – tiny circular pieces of DNA usually from bacteria that is used to insert recombinant DNA into an organism

31. rDNA to GMO Recombinant DNA – DNA created from two or more sources Genetically modified organism (GMO) – organism that contains DNA from another organism and produces new proteins encoded on the acquired DNA Restriction enzymes, DNA ligase, and plasmids leads to

32. What is Genetic Engineering? Genetic engineering refers to the modification of genetic material to achieve specific goals We can modify organisms to express genes they never had and make proteins they never have before

33. Gene Engineered Plant. Scientists have learned how to insert 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. Examples of GMOs

34. foodsanimals

35. Producing Genetically Engineered t-PA. Humans make only a small amount of human tissue plasminogen activator (t-PA) naturally. By genetically modifying Chinese hamster ovary (CHO) cells, scientists can make large amounts of t- PA for therapeutic purposes, such as to clear blood vessels in the event of a heart attack or stroke. Examples of GMOs

36. Recombinant DNA and genetic engineering produces 100’s of products Examples of GMOs

37. The Human Genome Project Determined the human DNA sequence Determined the human DNA sequence Scientists now work on: Scientists now work on: Identifying all of the genes Identifying all of the genes Determining their functions Determining their functions Understanding how and when genes are turned on and off Understanding how and when genes are turned on and off What can this project do to advance biotechnology? What can this project do to advance biotechnology?

38. How Companies Select Products to Manufacture Each biotechnology company usually specializes in a group of similar products Plant products Plant products Fermentation equipment Fermentation equipment Viral therapies Viral therapies DNA sequencers for research DNA sequencers for research Enzymes for food processing Enzymes for food processing Developing Ideas for New Products Ideas come from many sources: What are some?What are some?

39. Step 1: Product Development Plan Product Development Plan usually includes the following criteria: Does the product meet a critical need? Who will use the product?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?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?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 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?Can the company make a profit on the product? How much will it cost to make it? How much can it be sold for? Before going into research and development, company officials must determine whether or not it is worth the investment of company resources. “The Product Pipeline”

40. Step 2: Research and Development Research: Is it feasible to produce new medicine in sufficient amounts?Is it feasible to produce new medicine in sufficient amounts? Is it safe?Is it safe? Is there proof of efficacy? (product does what it claims to do)Is there proof of efficacy? (product does what it claims to do) Is it stable over time?Is it stable over time? Clinical Development: Small then large scale productionSmall then large scale production Clinical trials- strict testing that evaluates effectivenessClinical trials- strict testing that evaluates effectiveness Drugs must pass 3 phases of clinical trials with 1000’s of patients before permission from FDA to take product to marketDrugs must pass 3 phases of clinical trials with 1000’s of patients before permission from FDA to take product to market While the product is in the product pipeline, it is constantly being evaluated by the Product Development Plan (10 to 15 years) Situations That End Product Development Product development is stopped if testing shows the product is not effective.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.When this happens, companies can lose millions of dollars and years of research and development time. “The Product Pipeline”

41. Federal agencies governing product development Food and Drug Administration (FDA)- regulates the use and production of food, feed, food additives, veterinary drugs, human drugs, and medical devices Food and Drug Administration (FDA)- regulates the use and production of food, feed, food additives, veterinary drugs, human drugs, and medical devices Environmental Protection Agency (EPA)- enforces environmental laws including the use and production of microorganisms, herbicides, pesticides, and genetically modified microorganisms Environmental Protection Agency (EPA)- enforces environmental laws including the use and production of microorganisms, herbicides, pesticides, and genetically modified microorganisms United States Department of Agriculture (USDA)- regulates the use and production of plants, plant products, plant tests, veterinary supplies and medications, and genetically modified plants and animals United States Department of Agriculture (USDA)- regulates the use and production of plants, plant products, plant tests, veterinary supplies and medications, and genetically modified plants and animals

42. Regulations Governing Product Development New Biotech Drug Approvals. Even with all the government regulations, the number of new drugs approved for market increased nearly seven times in the 10 years between 1990 and 2000.

43. Students are often taught that there is a “scientific method.” What are the steps? Lets Define some key terms Doing Biotechnology

44. Fact vs. Inference FACT An Observation –a thing that has been done –something shown to exist –something known to have existed –Confined to what one observes; cannot be made about the future INFERENCE Educated guess as to what happened based on facts (observations) –Conclusion –deduction –Judgment –Goes beyond what one observes; may concern the past, present or future

45. What is this item? List some facts.

46. IPOD Touch Magnifying lens picture may have told you it could surf the web What does the star represent? Other Facts?

47. What are the facts? 1.Deals with Algebra 2.Its hard 3.It has numbers on the cover 4.1 & 2 5.1 & 3 6.2 & 3 7.None of the above

48. What are the facts? 1.Deals with Algebra 2.Its hard 3.It has numbers on the cover 4.1 & 2 5.1 & 3 6.2 & 3 7.None of the above

49. What are the inferences? 1.He has something to do with baseball 2.He is wearing a uniform 3.He has gloves on 4.He just hit a ball 5.1 & 2 6.1 & 4 7.3 & 4

50. What are the inferences? 1.He has something to do with baseball 2.He is wearing a uniform 3.He has gloves on 4.He just hit a ball 5.1 & 2 6.1 & 4 7.3 & 4

51. Observations All scientific inquiry begins with careful and systematic observation Observations are used to form a question about something

52. Hypothesis Proposed answer for a scientific question Is specific and testable Based on education Usually takes many experiments to get enough data to form a conclusion

53. Experimentation Scientist use experimentation to test hypotheses We conduct an experiment and observations lead to data

54. Types of Data Qualitative –Subjective –Data can be interpreted differently depending on the person –What are some examples? Quantitative –Objective measurements –What are some examples?

55. Types of Data What are some qualitative and quantitative observations you have about this picture?

56. Experimentation During experimentation we study factors called independent and dependent variables to find cause-and-affect relationships

57. Independent Variables Independent variable: –A condition that is manipulated or changed by the scientist in the experiment –Only one independent variable should be tested at a time

58. Dependent Variables Are variables that are observed and measured during an experiment The experimental data Changes in the dependent variable depend on the manipulation of the independent variable

59. Cause and Effect The independent variable is the presumed cause and the dependent variable is the presumed effect

60. Try These Hypothesis: If a high school biology student participates in a study group for 30 minutes every night, they will score higher on the Biology EOCT than a student that does not participate. What is the Independent Variable? What is the Dependent Variable?

61. Try These A high school student believes that her biology teacher might give better test scores when she receives chocolate. Hypothesis: The more chocolate you give a teacher before she grades an exam, the better score she will give What is the Independent Variable? What is the Dependent Variable? PS. You are welcome to bring chocolate but you wont get a better grade

62. Constants If we only test one independent variable per experiment, all other conditions must stay the same The conditions that stay the same during an experiment are called the constants What is a control group? How many control groups must every experiment have?

63. Experimentation Once you have designed your experiment, you must conduct it A good experiment must be conducted at least 3 times. Why?

64. Accuracy vs. Precision Accuracy The accuracy of an experiment/object/value is a measure of how closely the experimental results agree with a true or accepted value Precision The precision of an experiment/object/value is a measure of the reliability of the experiment, or how reproducible the experiment is

65. Example We measure the length of a 1 foot ruler and get values of: 13.01 in, 13.00 in, 12.99 in, 13.00 in. Are our results Accurate? Are they Precise?

66. Example These numbers are precise enough for us to believe that if we measure it again we would get 13.00+0.01 in. These measurements are precise but accurate. Why?

67. More on experimentation Data is usually quantitative Multiple trials In Biotechnology, you will almost always have two controls: –Positive control- a group of data that will give predictable positive results –Negative control – a group of data that will give predictable negative results

68. Analyzing Data After data collection, we must analyze the data and form a conclusion If the data supports the conclusion and is statistically significant then we accept the hypothesis If the data does not support the conclusion and is not statistically significant we reject the hypothesis

69. After Many Experiments After many experiments by different scientists, we can form a theory Theory: A proposed explanation for observational and experimental results that is supported by evidence –These are not proven but can be accepted –Can change over time –They are the WHY!!!!!

70. After Many Experiments Law: A mathematical statement that allows you to model the world –Tells you what will happen –Does not explain why –How is this different from a theory? –What are some scientific laws?

71. More on conclusions REE, PE, PA Method –REE- results with evidence and explanation –PE- possible errors –PA- practical application How are the findings valuable to the company? Recommendations for further experimentation proofread and witnessed by member not involved in experiment

72. Sharing Experimental Results with the Scientific Community Once an experiment is complete, the work is reported to others through: Publications Publications Presentations Presentations Annual conferences Annual conferences

73. One of the fastest growing commercial industries 7 out of 10 jobs posted with large companies are for laboratory technicians Industry will be studying DNA sequence for most of the 21 st century Careers in the Biotechnology Industry

75. Categories of Biotechnology Jobs Scientific PositionsScientific Positions Research and DevelopmentResearch and Development Manufacturing and ProductionManufacturing and Production Clinical ResearchClinical Research Quality ControlQuality Control Nonscientific PositionsNonscientific Positions Information SystemsInformation Systems Marketing and SalesMarketing and Sales Regulatory AffairsRegulatory Affairs Administration/Legal AffairsAdministration/Legal Affairs