What is Biotechnology?

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What is Biotechnology?
Chapter 1
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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

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

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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

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

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Vocabulary

• Research and development (RD) 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

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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.

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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.
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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.
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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.
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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

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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

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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.

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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

• 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

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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

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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.

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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.
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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?

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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.

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Develop a testable hypothesis
Diluting Bleach Hypothesis. Higher concentrations
of bleach should cause more color fading.
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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.
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Sharing Experimental Results with the Scientific
Community

• Once an experiment is complete, the work is
  reported to others through
• Publications
• Presentations
• Annual conferences

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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

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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.

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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

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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

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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

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Vocabulary

• Genome one entire set of an organisms 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

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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?

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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.

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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.

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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.

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• Questions and Comments?