Describe the science of biotechnology and
identify its product domains
Give examples of careers and job
responsibilities associated with
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
Apply the strategy for values clarification to
1.1 Defining Biotechnology
Biotechnology is defined
as the study and
manipulation of living
things or their component
molecules, cells, tissues,
– a protein that facilitates the uptake of sugar into cells
from the blood
– 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
– method of asexual reproduction that produces
– a process by which, in an oxygen
deprived environment, a cell converts sugar into lactic
acid or ethanol to create energy
– a disorder affecting the uptake of sugar
by cells, due to inadequate insulin production or
ineffective use of insulin
– proteins whose function is to break
down other proteins
– proteins developed by the immune
system that recognize specific molecules (antigens)
– relating to drugs developed for
Biotechnology Workers and the Biotechnology Workplace
Biotechnology Companies goal is to
produce and sell commercial “forprofit”
Universities and Government Labs conduct
“pure science” research, nonprofit
Growth in the Biotechnology Industry
Domains of Biotechnology
. The major domains of biotechnology include 1) industrial
and environmental; 2) medical/pharmaceutical; 3) agricultural; and 4) diagnostic/research
Science and Business of Biotechnology
Basic Biology and Chemistry Concepts
Recombinant Protein Product
Applications of Biotechnology in Agriculture
Recent Advances in Biotechnology
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 smallscale production
– scientific research whose main
purpose is to enrich the scientific knowledge base
– a particle containing a protein coat and
genetic materials (either DNA or RNA) that is not
living and requires a host to replicate
– the practice of utilizing scientific knowledge for
practical purposes, including the manufacture of a product
– abbreviation for National Institutes of Health; the federal agency
that funds and conducts biomedical research
– 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
– an experimental technique that is commonly
used to identify individuals by distinguishing their unique DNA code
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.
Industrial products such as rubber, turpentine, and maple
As the methods of manipulating living things have
become more sophisticated, the number and
variety of biological products have increased at an
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
Humans make only a
small amount of human
activator (tPA) 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.
The Human Genome Project
Determining the human DNA sequence
Understanding the function of the human genetic
Identifying all of the genes
Determining their functions
Understanding how and when genes are turned
on and off throughout the lifetime of an individual
– molecular agents derived from fungi and/or bacteria that
impede the growth and survival of some other microorganisms
– enzyme that cuts DNA at a specific nucleotide
– an enzyme that binds together disconnected strands of a
– DNA created by combining DNA from two or more
Genetically modified organisms
– organisms that contain DNA from
another organism and produce new proteins encoded on the acquired DNA
– a rodshaped bacterium native to the intestines of mammals;
commonly used in genetics and biotechnology
1.3 How Companies Select Products to Manufacture
Each biotechnology company usually specializes in a group of
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
Research and Development
– chemical used in an experiment
– the ability to yield a desired result or demonstrate that a product does what it claims to do
– the manufacture of large volumes of a product
– a strict series of tests that evaluates the effectiveness and safety of a medical
treatment in humans
– 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
– an agent that is used to treat diseases or disorders
– 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
– 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 Plan
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
Do preliminary data support that the product will work? Will the product do what the
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?
Before going into research and development, company officials must
determine whether or not it is worth the investment of company resources.
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 Development
New Biotech Drug
all the government
number of new drugs
approved for market
increased nearly seven
times in the 10 years
between 1990 and
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
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
State a testable scientific question or problem based on some information
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.
Develop a testable hypothesis
Diluting Bleach Hypothesis
Higher concentrations of bleach
should cause more color fading.
Data Table and Graph
and measurements are reported in data
table. Individual trials (replications) as
well as averages are shown. Numerical
data are shown in picture form using
Sharing Experimental Results with the Scientific
Once an experiment is complete, the work is reported to others through:
– information gathered from experimentation
– an educated guess to answer scientific question; should be testable
– anything that can vary in an experiment; the independent variable is tested in an
experiment to see its effect on dependent variables
– experimental trial added to an experiment to ensure that the experiment was run
– a group of data that will give predictable positive results
– a group of data that will give predictable negative results
– the amount of a substance as a proportion of another substance; usually
how much mass in some amount of volume
– scientific periodicals or magazines in which scientists publish their experimental
work, findings, or conclusions
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
fivestep 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
One of the fastest growing commercial industries
Career opportunities in:
Industry will be studying DNA sequence for most of the
1.5 Careers in the Biotechnology Industry
Bachelor of Science Degree
2year college degree
High school specialization
More advanced degrees
Master of Science
Master of Arts
Doctor of Philosophy
Postdoctoral research experience
Nonscientific Positions and
Employees in nonscientific positions must have
an interest in and understanding of the science
Categories of Biotechnology Jobs
Research and Development
Manufacturing and Production
Marketing and Sales
– one entire set of an organism’s genetic material (from a single cell)
– the study of the chemical reactions occurring in living things
– the study of molecules that are found in cells
– the study of genes and how they are inherited and expressed
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
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?
1.6 Biotechnology with a Conscience
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?
Being able to distinguish between right and wrong and to make
decisions based on that knowledge is considered “having good
The study of moral standards and how they affect conduct is called
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
Based on the pros and cons for each solution, rank all solutions from best
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 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
Questions and Comments?