Intro Biotech Unit 1

Biotechnology Companies four categories

Pharmaceutical/Medical products, Agricultural products, Industrial/Environmental products, Research or production instruments, reagents, or data

What group of potential products must be tested in clinical trials before it can be marketed?

Pharmaceuticals

Each biotechnology company usually specializes in a group of similar products and they are

Plant products, Fermentation equipment, Viral therapies, DNA sequencers for research, Enzymes for food processing

Antibodies

Proteins developed by the immune system that recognize specific molecules (antigens)

Proteases

Proteins whose function is to break down other proteins

Once an experiment is complete, the work is reported to others through:

Publications, Presentations, Annual conferences

Bioengineered or genetically modified organisms (GMOs).

Recombinant DNA can be inserted into cells, where it is used to produce new products.

Pharmaceutical

Relating to drugs developed for medical use

Categories of Scientific Career Positions:

Research and development • manufacturing and production • clinical research • quality control Categories of Nonscientific Positions: • information systems • marketing and sales • regulatory affairs • administration/ legal affairs

What kind of enzymes allow scientists to cut and paste pieces of DNA together to form recombinant DNA?

Restriction Enzymes (cuts DNA) DNA ligase (pastes DNA together)

Conclusion Guidelines

Results with evidence and explanation of support of refute of hypothesis Possible errors in experimental design and how to minimize them Practical applications of results and how they may be used (REE PEE PA)

the number and variety of new biological products have increased or decreased?

Increased at an incredible rate.

Data

Information gathered from experimentation

Why does it take nearly 15 years to bring a drug to market?

Long process: 1. Product identification 2. Research and Development 3. Small-scale manufacturing 4. Testing for safety and efficacy 5. Manufacturing 6. Sales and Marketing

Why are the stages in product development different at every company

because each product has specific requirements, but most product development follows the basic outline

To be a more advance Research Associate you have to...

Masters (MS/MA)

Microbial agents

Microorganisms; living things too small to be seen without the aid of a microscope; includes bacteria, most algae, many fungi

Antibiotics

Molecular agents derived from fungi and/or bacteria that impede the growth and survival of some other microorganisms

Does every product in research and development (R&D) make it to market? Yes or no?

No, it may be too costly to produce

Data Tables and Graphs

Observations and measurements are reported in data tables. Individual trials (replications) as well as averages are shown. Numerical data are shown in picture form using graphs.

Genome

One entire set of an organism's genetic material (from a single cell)

Genetically modified organisms

Organisms that contain DNA from another organism and produce new proteins encoded on the acquired DNA

Biotechnology

the application of science and engineering to manipulate cells and their components to produce products or services that may improve the quality of human life.

To be a scientist you have to...

Doctorate (PhD), Post-Doctorate

t-PA

(tissue plasminogen activator) - a naturally occurring enzyme that breaks down blood clots and clears blocked blood vessels

Domains of Biotechnology.

1) industrial and environmental; 2)medical/pharm ceutical; 3) agricultural; and 4) diagnostic/ research

Scientists search for products that improve the quality of life. (categories)

1. Antibiotics and other medical products 2. Industrial products such as rubber, turpentine, and maple syrup 3. Agricultural products

Strategy for Values Clarification

1. Identify and understand the problem or issue. Learn as much as possible about the issue 2. List all possible solutions to the issue. 3. 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. 4. Based on the pros and cons for each solution, rank all solutions from best to worst. 5. 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.

Scientific Method

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 data into tables, charts, graphs, or graphics. 5. Formulate a conclusion based on experimental data and error analysis

Reagent

A chemical used in an experiment

Moral

A conviction or justifiable position, having to do with whether something is right or wrong

Cystic fibrosis (CF)

A genetic disorder that clogs the respiratory and digestive systems with mucus

Negative control

A group of data that will give predictable negative results

Positive control

A group of data that will give predictable positive results

Cloning

A method of asexual reproduction that produces identical organisms

Virus

A particle containing a protein coat and genetic materials (either DNA or RNA) that is not living and requires a host to replicate

Company officials must determine whether or not a...

A product is worth the investment of company resources

Insulin

A protein that facilitates the uptake of sugar into cells from the blood

E. coli

A rod-shaped bacterium native to the intestines of mammals; commonly used in genetics and biotechnology

Clinical trials

A strict series of tests that evaluates the effectiveness and safety of a medical treatment in humans

Polymerase chain reaction (PCR)

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 extra chromosomal DNA, used in recombinant DNA technologies

To be a Lab Technician/ Assistant or Biotechnician you have to...

AA/AS (2-year college degree/certificate)

CDC

Abbreviation for Centers for Disease Control and Prevention; the national research center for developing and applying disease prevention and control, environmental health, and health promotion and education activities to improve public health

NIH

Abbreviation for National Institutes of Health; the federal agency that funds and conducts biomedical research

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

DNA

Abbreviation for deoxyribonucleic acid, a double-stranded helical molecule that stores genetic information for the production of all of an organism's proteins

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

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

Hypothesis

An educated guess to answer 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

An experimental trial added to an experiment to ensure that the experiment was run properly; see positive control and negative control

Variable

Anything that can vary in an experiment; the independent variable is tested in an experiment to see its effect on dependent variables

To be a Research Associate you have to...

Bachelor of Science Degree in (Biochemistry, Molecular biology, Genetics)

Universities and Government Labs

Conduct "pure science" research, nonprofit

Recombinant DNA (rDNA) technology

Cutting and recombining DNA molecules

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

Developing Ideas for New Products

Discussions lead to new ideas, Reading literature reviews can lead to new ideas, Sometimes even daydreaming can lead to new ideas

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?

(T/F) New technologies generate ethical questions that can be answered using scientific methods.

False its cannot

Biotechnology Companies

Goal is to produce and sell commercial "for-profit" products.

How can the Strategy for Values Clarification can be used to solve a problem such as the use of embryonic stem cells?

Helps an individual form a position on an issue and be able to justify it

Why might having lab experience be a benefit for a nonscientific employee at a biotechnology company

Helps employees work more productively with all members of the company

To be a Lab Technician/Assistant you have to...

High school specialization

Process of 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.

Majors or minors in a scientific field along with a business degree and experience is helpful for careers in:

Sales, Marketing, Regulatory, Legal, Financial, Human resources, Administrative staff

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

Genetically 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.

What types of biotechnology employees is currently in large demand?

Technicians and Lab directors, senior scientists, staff scientists

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.

Efficacy

The ability to yield a desired result or demonstrate that a product does what it claims to do

Concentration

The amount of a substance as a proportion of another substance; usually how much mass in some amount of volume

Research and development (R&D)

The early stages in product development that include discovery of the structure and function of a potential product and initial small-scale production

Large-scale production

The manufacture of large volumes of a product

Applied science

The practice of utilizing scientific knowledge for practical purposes, including the manufacture of a product

Genetics

The study of genes and how they are inherited and expressed

Molecular biology

The study of molecules that are found in cells

Bioethics

The study of moral decisions and making decisions made because of advances in biology, medicine, and technology

Ethics

The study of moral standards and how they affect conduct

Biochemistry

The study of the chemical reactions occurring in living things

(T/F) Biotechnology is of the fastest growing commercial industries

True

Besides biotechnology companies, where can biotechnologist work?

University labs, Government agencies

Diabetes

a disorder affecting the uptake of sugar by cells, due to inadequate insulin production or ineffective use of insulin

Fermentation

a process by which, in an oxygen-deprived environment, a cell converts sugar into lactic acid or ethanol to create energy