biotech chapter 1
Many companies develop a ___________ for each potential product on the line
"comprehensive product development plan"
fourth step in sm
Conduct outlined experiment and collect and organize data into tables, charts, graphs, or graphics
Recombinant DNA
DNA created by combining DNA from two or more sources
The use of what kind of enzyme allows scientist to paste pieces of DNA together to form recombinant DNA?
DNA ligase
second step in sm
Develop testable hypothesis
Practical Applications (PA)
Discuss meaning/value of experiment results
The plan usually includes
Does the product meet a critical need? Who will use the product? Is the market long 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?
Regulatory guidelines during the production of drugs and cosmetics, chemicals, and crops are written and overseen by agencies such as the
FDA, environmental protection agency (EPA) or US department of agriculture (USDA)
allows tomatoes to ripen on the vine longer for better flavor.
FLAVR SAVR by Calgene
fifth step in sm
Formulate conclusion based on experimental data and error analysis
Where did rubber come from? What did it help invent?
The rubber tree / Tires
How are "stone washed" jeans made today?
They are genetically engineered with enzyme products called IndiAge.
What is Cipro?
a strong antibiotic that kills many bacteria and is produced by Bayer Healthcare
Bleach
a strong oxidizing agent that will fade the colored dye in fabric
Polymerase chain reaction
a technique that involves copying short pieces of DNA and then making millions of copies in a short time.
plasmid
a tiny, circular piece of DNA, usually of bacterial origin; often used in recombinant DNA technologies
Auriculin
is an example of therapeutic drug developed by Scios for kidney failure
Recording, analyzing, and reflecting data
is critical in case disputes arise regarding scientific discoveries
Common for all biotech employees
is the basic understanding of the science and economics of the industry
10 to 15 years for
large pipeline
Bioscience includes
medical, agricultural, and environmental applications, applied chemistry, physics, and computer science
antibiotics
molecular agents derived from fungi and/or bacteria that impede the growth and survival of some other microorganisms
Products are pulled from pipeline for
not being effective
R&D, Sales, and Profit Spiral
once a company starts marketing a product, it earns revenue. If revenue are high enough and the company has profits, it can reinvest those profits into more research and development.
Genome
one entire set of an organism's genetic material
Tissue plasminogen activator (t-Pa)
one of the first genetically engineered products to be sold; a naturally occurring enzyme that breaks down blood clots and clears blocked blood vessels
As biotechnology industry matures
opportunities for employees are immense
genetically modified organisms (GMOs)
organisms that contain DNA from another organism and produce new proteins encoded on the acquired DNA
Goal of every biotechnology company
produce and sell commercial "for-profit" products.
Usually takes about 10 to 15 years for a company to move a drug through the steps called the
product pipeline
antibodies
proteins developed by the immune system that recognize specific molecules
proteases
proteins whose function is to break down other proteins.
The protocols for manufacturing recombinant human growth hormone are almost identical to producing
recombinant human insulin
pharmaceutical
relating to drugs developed for medical use
As the initial investment money is recouped and profits are generated, companies can hire more staff for more
research
Most lab requirements include
4 year college degree
Auriculin was on pipeline for over
5 years
"proof of concept"
A drug must demonstrate ___________ data in the research laboratory before the project moves into the development phase
lovastatin is a drug isolated from a strain of the fungus...
Aspergillus terreus
The major domains of Biotechnology:
1.) Pharmaceutical 2.) Agricultural 3.) Industrial 4.) Diagnostic/Research
What can you genetically engineer to make more t-PA cells?
Genetically modifying chinese hamster ovary (CHO) cells, scientists can make large amounts of t-PA for therapeutic purposes.
Results with evidence and explanation (REE)
Give answer to purpose question using numerical data/results and support/refute hypothesis, explain why using examples
Replication
Multiple/individual trials
Name two antibiotics used as medicines.
Penicillin, Cipro, amoxicillin, carbenicillin (any of these)
Penicillin is from a species of the fungus...
Penicillium sp.
third step in sm
Plan valid experiment Numerical data, Multiple trials, 1 manipulated variable, Control groups can be (positive and negative)
Stages in development
Product identification: a product of interest is identified and evaluated for possible research and manufacturing Research and development: researchers develop the techniques to make new products such as genetically engineered proteins - bacteria is tricked to make human insulin Small scale manufacturing: increasingly larger volumes of product are made for testing and further experimentation Testing for safety and efficacy: a product is tested to make sure it is safe and effective. If the product is to be a pharmaceutical, it must undergo testing called clinical trials Manufacturing: manufacturing involves cell culture and product purification Sales and marketing: product is ready for distribution. Additional testing for other application is done For a pharmaceutical product, it must pass through Phase 3 clinical trials with thousands of patients included in testing before application with FDA for permission for more product to be produced
The use of what kind of enzyme allows scientists to cut DNA?
Restriction Enzymes
first step in sm
State a testable scientific question/problem based on information/observation
Efficacy
The ability to yield a desired result or demonstrate that a product does what it claims to do
Gene engineered stuff
The organism that gets the new genes will then have the potential to express the new traits coded in the newly acquired genes
Reagent
a chemical used in an experiment
Moral
a conviction or justifiable position, having to do with whether something is considered right or wrong
diabetes
a disorder affecting the uptake of sugar by cells, due to inadequate insulin production or ineffective use of insulin
EPA (Environmental Protection Agency)
a federal agency that enforces environmental laws including the use of production of microorganisms, herbicides, pesticides, and genetically modified microorganisms
Cystic Fibrosis
a genetic disorder that clogs the respiratory and digestive systems with mucus
Negative Control
a group of data lacking what is being tested so as to give expected negative results
Positive Control
a group of data that will give predictable positive results
cloning
a method of asexual reproduction that produces identical organisms.
viruses
a particle containing a protein coat and genetic material that is not living and requires a host to replicate.
fermentation
a process by which, in an oxygen-deprived environment, a cell converts sugar into lactic acid or ethanol to create energy.
What is Insulin?
a protein that facilitates the uptake of sugar into cells from blood
E. coli
a rod-shaped bacterium native to the intestines of mammals; commonly used in genetics and biotechnology. Also produces human somatostatin.
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
Therapeutic
an agent that is used to treat diseases or disorders
Hypothesis
an educated guess to answer a scientific question; should be testable
DNA ligase
an enzyme that binds together disconnected strands of a DNA molecule
Restriction Enzyme
an enzyme that cuts DNA at a specific nucleotide sequence
DNA fingerprinting
an experimental technique that is commonly used to identify individuals by distinguishing their unique DNA code.
Control Variable
an experimental trial added to an experiment to ensure that the experiment was run properly
Variable
anything that can vary in an experiment: the independent variable is tested in an experiment to see its effect on dependent variables
Computers
are used to produce reports of all experiments
Flavia Borellini, PhD, Lifecycle leader, Global Product Strategy, Oncology, Genentech, Inc. Dr. Borellini leads a team to develop and implement strategic plans for bringing promising new drugs that
combat cancer to market
recombinant DNA
cutting and combining DNA molecules
Use "REE, PE, PA"
for writing an experimental conclusion
Possible Errors (PE)
identify the possible errors and explain how they affected the experiment
moral ex: Vegans/Vegetarians
immoral to eat meat
Pulmozyme
improves the quality of life for patients with cf reducing the amount of mucus produced
Bachelor degree
in biochemistry, molecular biology, genetics, or biology
Data
information gathered from experimenting
Observation
information/data collected when subject is watched
3 rounds of clinical trials and a large number of patients to check the
safety and effectiveness of a drug
Journals
scientific periodicals or magazines in which scientists publish their experimental work, findings, or conclusions
pure science
scientific research whose main purpose is to enrich the scientific knowledge base
2 to 3 years for
small pipeline,
Microbial agents
synonym for microorganisms; living things too small to be seen without the aid of a microscope; includes bacteria, most algae, many fungi
Humans can only make a small amount of
t-PA cells.
The industry will be studying the meaning of a the DNA sequence for most of the 21st century because of the large amount of data collected by
the Human Genome Project
Concentration
the amount of a substance as a proportion of another substance: usually how much mass in some amount of volume
USDA (United States Department of Agriculture)
the federal agency that regulates the use and production of plants, plant products, plant pests, veterinary supplies and medications, and genetically modified plants and animals
Large Scale Production
the manufacturing of large volumes of a product
applied science
the practice of utilizing scientific knowledge for practical purposes, including the manufacture of a product
Biotechnology
the study and manipulation of living things or their component molecules, cells, tissues, or organs.
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
Genetics
the study of genes and how they are inherited and expressed
Molecular biology
the study of molecules that are found in cells
Ethics
the study of moral standards and how they affect conduct
Biochemistry
the study of the chemical reactions occurring in living things
PCR
was thought of while driving along a twisty mountain road late night in northern California