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. 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
5. 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
6. Domains of Biotechnology. The major domains of biotechnology include 1) industrial
and environmental; 2) medical/pharmaceutical; 3) agricultural; and 4) diagnostic/research
7. 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
8. 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
9. 1.1 Review Questions
1. 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.
10. 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.
11. 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.
12. 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.
13. 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
14. 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
15. 1.2 Review Questions
1. 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.
16. 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
17. 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
18. 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.
19. 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.
20. 1.3 Review Questions
1. 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?
21. 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
1. 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.
22. Develop a testable hypothesis
Diluting Bleach Hypothesis.
Higher concentrations of bleach
should cause more color fading.
23. 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.
24. Sharing Experimental Results with the Scientific Community
Once an experiment is complete, the work is reported to others through:
• Publications
• Presentations
• Annual conferences
25. 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
26. 1.4 Review Questions
1. 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.
27. 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
28. 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
29. 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
30. 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
31. 1.5 Review Questions
1. 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?
32. 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.
33. 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.
34. 1.6 Review Questions
1. 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.
