1. Chapter 1
What is Biotechnology?

2. Chp. 1- 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. 1.1 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
Produces variety/diversity in living things

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 have learned not just to manipulate whole organisms but also molecules, cells, tissues, and organs
New technologies are applied to the research and development of products from plant and animal tissues
The term “Biotechnology” was coined

11. 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

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

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

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

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

16. 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

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

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

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

20. Biotechnology Workers and the Biotechnology Workplace
Biotechnology Companies - goal is to produce and sell commercial “for-profit” products
Staff- scientists, researchers, lab technicians, manufacturing, marketing, sales
Lovastatin (trade name: Mevacor) is a cholesterol lowering drug while cyclopamine is a cancer drug.
Cyclopamine works by blocking the so-called “hedgehog” pathway, long known to promote and guide cell and organ growth while lovastatin (aside from cholesterol-clogging effects) is known to curb destruction of proteins that put the brakes on cell growth, causing cancer cells to self-destruct through a process called apoptosis.
The unlikely pair of these two compounds has been found by researchers at the Johns Hopkins Kimmel Cancer Center to dramatically kill brain cancer cells.
Fermentation tanks grow cells that produce pharmaceutical proteins for cancer vaccines and therapies at Genesys.

21. Biotechnology Workers and the Biotechnology Workplace
Universities and Government Labs - conduct “pure science” research, nonprofit
Report results in scientific journals or meetings for the “public good”

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

23. 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

24. 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)

25. Biotechnology Workers and the Biotechnology Workplace
Growth in the Biotechnology Industry:
Began in San Francisco Bay area, Boston, Massachusetts, Madison, WI, and in North Carolina. Now in most metropolitan areas.
Scientific and nonscientific support staff
By end of 2003: 198,000 biotech industry employees in 1500 biotech companies

26. 1.1 Review Questions
What is biotechnology?
Name a biotechnology product that has a medical use.
Besides biotechnology companies, where can biotechnologists work?
Biotechnology companies are grouped into four categories based on the products they make and sell. Name the four categories of products.

27. 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.” p. 10
Antibiotics
Industrial products such as rubber, turpentine, and maple syrup

28. Bioengineered Products
As the methods of manipulating living things have become more sophisticated, the number and variety of biological products have increased at an incredible rate

29. Techniques created in the 70’s
Restriction enzymes – cuts nucleotide sequence at specific sites on DNA molecule
DNA ligase – enzyme that pastes DNA molecules together allowing for new combinations

30. Techniques created in the 70’s
Plasmid – tiny circular piece of DNA usually from bacteria that is used to insert recombinant DNA into an organism

31. Techniques created in the 70’s
Restriction enzymes, DNA ligase, and plasmids
allows for
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
leads to

32. Examples of GMOs
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.

33. Examples of GMOs
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.

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

35. The Human Genome Project
Determined the human DNA sequence
Scientists now work on:
Identifying all of the genes
Determining their functions
Understanding how and when
genes are turned on and off

36. 1.2 Review Questions
The use of what kind of enzymes allows scientists to cut and paste pieces of DNA together to form recombinant DNA?
Explain how making human tissue plasminogen activator (t-PA) in Chinese hamster ovary (CHO) cells is an example of genetic engineering.

37. Developing Ideas for New Products
1.3 How Companies Select Products to Manufacture
Each biotechnology company usually specializes in a group of similar products
Plant products
Fermentation equipment
Viral therapies
DNA sequencers for research
Enzymes for food processing
Developing Ideas for New Products
Ideas 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

38. Step 1: Product Development Plan
“The Product Pipeline”
Step 1: Product Development Plan
Before going into research and development, company officials must determine 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?
Does 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?

39. Step 2: Research and Development
“The Product Pipeline”
Step 2: Research and Development
While the product is in the product pipeline, it is constantly being evaluated by the Product Development Plan (10 to 15 years)
Research:
Is it feasible to produce new medicine in sufficient amounts?
Is it safe?
Is there proof of efficacy? (product does what it claims to do)
Is it stable over time?
Clinical Development:
Small then large scale production
Clinical 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 market
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.

40. 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
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

41. 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.

42. 1.3 Review Questions
What group of potential products must be tested in clinical trials before it can be marketed?
A drug discovery process can take nearly 15 years. Explain why it takes so long to bring a new drug to market.
Which questions must be answered to the satisfaction of company officials before a product goes into research and then into development?
Does every product in research and development make it to market? Yes or no? Why?

43. 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 Methodologies
Testable scientific question or problem based on some information or observation.
Hypothesis- statement that attempts to answer question being posed
Experimentation
Conduct the outlined experiment and collect and organize the data into tables, charts, graphs, or graphics.
Formulate a conclusion based on experimental data and error analysis. Includes application of findings and suggestions for further experimentation.

44. More on experimentation
Data is usually quantitative
Multiple trials
Variables
Independent (manipulated)- changed during experiment
Dependent (responding)- measured
Positive control- a group of data that will give predictable positive results
Negative control – a group of data that will give predictable negative results

45. 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

46. Develop a testable hypothesis
Diluting Bleach Hypothesis. Higher concentrations of bleach should cause more color fading.

47. Data Table and Graph. Observations and measurements are reported in data table. Individual trials (replications) as well as averages are shown. Numerical data are shown in picture form using graphs.

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

49. 1.4 Review Questions
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.
Why do valid experiments contain many trials repeating the same version of an experiment?
In a conclusion, evidence for statements must be given. Describe the kind if evidence that is given in a conclusion statement.
Name two ways that scientists share their experimental results with other scientists.

50. One of the fastest growing commercial industries
1.5 Careers in the Biotechnology Industry
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 21st century

52. 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

53. 1.5 Review Questions
For which types of biotechnology employees is there currently a large demand? What are the educational requirements for these types of employees?
Scientific positions in most biotechnology companies fall into one of four categories. List them.
Why might having laboratory experience be a benefit for a nonscientific employee at a biotechnology company?

54. 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?
Read p

55. Bioethics Morals- a person’s beliefs of right and wrong
Ethics- the study of moral standards and how they affect conduct
New technologies generate ethical questions that cannot be answered using scientific methods.
Bioethics- the study of decision-making as it applies to moral decisions that have to be made because of advances in biology, medicine, and technology

56. 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 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.

57. 1.6 Review Questions
Define the term “bioethics.”
Give an example of an event that might lead a lab employee to be faced with an ethical issue.
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.