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