1. What is Biotechnology?
Chapter 1

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. 1.1 Defining Biotechnology
Biotechnology is defined as the study and manipulation of living things or their component molecules, cells, tissues, or organs.

4. SELECTIVE BREEDING

5. SELECTIVE BREEDING

6. SELECTIVE BREEDING

7. BIOTECHNOLOGY PRODUCTS USEFUL FOR SOCIETY

8. 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 – a 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

9. 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

10. RESEARCH & DEVELOPMENT

11. CELL GENESYS FERMENTATION TANKS

12. SCIENTIFIC METHOD

13. GLADSTONE INSTITUTE OF VIROLOGY

14. DNA FINGERPRINTING

15. 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

16. 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

17. Vocabulary
Research and development (R&D) –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; the 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

18. 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.

19. 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 syrup
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.

20. BIOTECHNOLOGY ANTIBIOTICS

21. Genetically modified organisms – organisms that contain DNA from another organism and 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.

22. Producing Genetically Engineered t-PA
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.

23. BIOTECHNOLOGY PRODUCTS

24. 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

25. Vocabulary
Antibiotics – molecular agents derived from fungi and/or bacteria that impede the growth and survival of some other microorganisms
Restriction enzyme – an enzyme that cuts DNA at a specific nucleotide sequence
DNA ligase – an enzyme that binds together disconnected strands of a DNA molecule
Recombinant DNA (rDNA) – DNA created by combining DNA from two or more sources
Genetically modified organisms (GMO) – 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

26. 1.2 Review Questions Name two antibiotics used as medicines.
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.

27. 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

28. DNA SEQUENCER

29. Research and Development
Vocabulary
Reagent – a 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) – a 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

30. A 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?
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.

31. STAGES IN PRODUCT DEVELOPMENT

32. THE CELL GENESYS PRODUCT PIPELINE

33. 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 There were 24 new approvals in 2008.

34. 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 (R&D) make it to market? Yes or no? Why?

35. 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
State a testable scientific question or problem based on some information or observation.
Develop a testable hypothesis.
Plan a valid experiment.
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.

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

37. 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.

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

39. 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 – an 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

40. 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.

41. 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

42. Educational Requirements
Nonscientific Positions and Educational Requirements
Bachelor of Science Degree
Biochemistry
Molecular biology
Genetics
2-year college degree
High school specialization
More advanced degrees
Master of Science
Master of Arts
Doctor of Philosophy
Postdoctoral research experience
Employees in nonscientific positions must have an interest in and understanding of the science of biotechnology.
Sales
Marketing
Regulatory
Legal
Financial
Human resources
Administrative staff

43. 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

44. 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

45. 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?

46. 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.

47. 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.

48. 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.

49. Questions and Comments?