Introduction to Biotechnology!

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

Defining Biotechnology

Biotechnology- the study and manipulation of living things or their

component molecules, cells, tissues, or organs.

The beginning of biotechnology

• Humans have been manipulating living things for thousands of years

• Selective breeding- manipulating living things with desired characteristics

• Why?

• Examples?

Beginning of Biotechnology

• Over 100 breeds of dogs created through selective breeding

Beginning of Biotechnology

• Different varieties of apples commonly found in grocery stores

Beginning of Biotechnology

• Range of size, color, and fragrance for a variety of roses

Beginning of Biotechnology

• Cows, goats, sheep, and chickens for milk, meat, and egg production

Beginning of Biotechnology

• Fermentation of foods and beverages

The 1970’s

• Scientists began experimenting with molecules, cells, tissues, and organs (moving away from entire organisms). WHY?

• New technologies are applied to the research and development of products from plant and animal tissues

• The term “Biotechnology” was coined

Levels of Biological Organization

• Cells of multicellular organisms are usually grouped into functional units:– Tissues– Organs

• Cells are the smallest units of life. Some cells contain even smaller, nonliving units.

Biotechnology today

• Focuses on DNA Deoxyribonucleic Acid- a double-stranded helical molecule that stores genetic information for the production of all the organism’s proteins

The Central Dogma of Biology states that DNA codes for RNA and that RNA codes for proteins (DNA -> mRNA -> proteins). Moving genes into cells to produce new proteins is the basic principle in genetic engineering.

The Central Dogma of Biology.

Recent uses of biotechnology

• Insulin- made in bacteria cells to treat diabetes

• Originally insulin was harvested from the pancreas of a slaughtered animal for treatment

Recent uses of biotechnology

• Proteases- proteins that break down other proteins

• Commonly used in stain removal products

Recent uses of biotechnology

• Antibiotics- proteins developed by the immune system that recognize a specific molecule (antigen)

• Used to fight diseases

Recent uses of biotechnology

• Indiage- protein (enzyme) that causes denim to fade to produce “stonewashed” appearance

Recent uses of Biotechnology

• Mouse cells “tricked” into growing outer portion of a human ear which can be surgically transferred to a human patient

Recent Advances in Biotechnology come from Manipulation of DNA!

What do you think of when you hear this?

Techniques used to manipulate DNA

• Recombinant DNA (rDNA) technology- cutting and recombining DNA molecules

E. Coli transformation

Techniques used to manipulate DNA

• Polymerase Chain Reaction (PCR)- copying short pieces of DNA

• Amplifies DNA sample

Techniques used to manipulate DNA

• Cloning- producing identical organisms

Who is practicing Biotechnology?

The Biotechnology Workplace Biotechnology Companies - goal is to produce

and sell commercial “for-profit” productsStaff- scientists, researchers, lab technicians, manufacturing, marketing, sales

Universities and Government Labs - conduct “pure science” research, nonprofit

Report results in scientific journals or meetings for the “public good”

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

Government Agencies

• CDC 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

• NIH National Institutes of Health- the federal agency that funds and conducts biomedical research

Other institutions• DNA fingerprinting used by:

– Forensic scientists within police departments to identify suspects

– Ecologists to determine parentage of endangered species for breeding purposes

– Wildlife biologists/customs agents to identify illegally poached or transported animals (bear gall bladders, rhinoceros horns, ivory from tusks, exotic birds)

– Evolutionary biologists to determine relatedness of organisms (red panda is more closely related to the raccoon than it is to the black and white panda bear)

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.”

As the methods of manipulating livings have become more sophisticated, the number and variety of biological products have increased at an incredible rate

Techniques That Make Manipulation Possible

• Restriction enzymes – cuts nucleotide sequence at specific sites on DNA molecule

• DNA ligase – enzyme that pastes DNA molecules together allowing for new combinations

Together these allow for us to make recombinant DNA molecules!

Techniques That Make Manipulation Possible

• Plasmids – tiny circular pieces of DNA usually from bacteria that is used to insert recombinant DNA into an organism

rDNA to GMO

• Recombinant DNA – DNA created from two or more sources

• Genetically modified organism (GMO) – organism that contains DNA from another organism and produces new proteins encoded on the acquired DNA

Restriction enzymes, DNA ligase, and plasmids

leads to

What is Genetic Engineering?

• Genetic engineering refers to the modification of genetic material to achieve specific goals

• We can modify organisms to express genes they never had and make proteins they never have before

Gene Engineered Plant. Scientists have learned how to insert 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.

Examples of GMOs

Examples of GMOs

foods animals

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.

Examples of

GMOs

• Recombinant DNA and genetic engineering produces 100’s of products

Examples of GMOs

The Human Genome Project

Determined the human DNA sequence Scientists now work on:

Identifying all of the genes Determining their functions Understanding how and when genes are

turned on and off

What can this project do to advance biotechnology?

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

Developing Ideas for New ProductsIdeas come from many sources:• What are some?

Step 1: 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

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?

Before going into research and development, company officials must determine whether or not it is worth the investment of company resources.

“The Product Pipeline”

Step 2: Research and Development

Research:• Is it feasible to produce new medicine in sufficient amounts?• Is it safe?• Is there proof of efficacy? (product does what it claims to do)• Is it stable over time?Clinical Development:• Small then large scale production• Clinical trials- strict testing that evaluates effectiveness• Drugs must pass 3 phases of clinical trials with 1000’s of patients before

permission from FDA to take product to market

While the product is in the product pipeline, it is constantly being evaluated by the Product Development Plan (10 to 15 years)

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.

“The Product Pipeline”

Federal agencies governing product development

Food and Drug Administration (FDA)- regulates the use and production of food, feed, food additives, veterinary drugs, human drugs, and medical devices

Environmental Protection Agency (EPA)- enforces environmental laws including the use and production of microorganisms, herbicides, pesticides, and genetically modified microorganisms

United States Department of Agriculture (USDA)- regulates the use and production of plants, plant products, plant tests, veterinary supplies and medications, and genetically modified plants and animals

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.

Students are often taught that there is a “scientific method.”

What are the steps?

Lets Define some key terms

Doing Biotechnology

Fact vs. Inference

FACT• An Observation

– a thing that has been done

– something shown to exist

– something known to have existed

– Confined to what one observes; cannot be made about the future

INFERENCE• Educated guess as to

what happened based on facts (observations)– Conclusion– deduction – Judgment– Goes beyond what

one observes; may concern the past, present or future

What is this item?List some facts.

IPOD Touch

• Magnifying lens picture may have told you it could surf the web

• What does the star represent?

• Other Facts?

What are the facts?

1. Deals with Algebra

2. Its hard

3. It has numbers on the cover

4. 1 & 2

5. 1 & 3

6. 2 & 3

7. None of the above

What are the facts?

1. Deals with Algebra

2. Its hard

3. It has numbers on the cover

4. 1 & 2

5. 1 & 3

6. 2 & 3

7. None of the above

What are the inferences?

1. He has something to do with baseball

2. He is wearing a uniform

3. He has gloves on

4. He just hit a ball

5. 1 & 2

6. 1 & 4

7. 3 & 4

What are the inferences?

1. He has something to do with baseball

2. He is wearing a uniform

3. He has gloves on

4. He just hit a ball

5. 1 & 2

6. 1 & 4

7. 3 & 4

Observations

• All scientific inquiry begins with careful and systematic observation

• Observations are used to form a question about something

Hypothesis

• Proposed answer for a scientific question • Is specific and testable• Based on education• Usually takes many experiments to get enough

data to form a conclusion

Experimentation

• Scientist use experimentation to test hypotheses• We conduct an experiment and observations lead

to data

Types of Data

• Qualitative– Subjective– Data can be interpreted differently depending on the

person– What are some examples?

• Quantitative– Objective measurements– What are some examples?

Types of Data

• What are some qualitative and quantitative observations you have about this picture?

Experimentation

• During experimentation we study factors called independent and dependent variables to find cause-and-affect relationships

Independent Variables

• Independent variable:– A condition that is manipulated or changed by the

scientist in the experiment– Only one independent variable should be tested at a

time

Dependent Variables

• Are variables that are observed and measured during an experiment

• The experimental data• Changes in the dependent variable depend on

the manipulation of the independent variable

Cause and Effect

• The independent variable is the presumed cause and the dependent variable is the presumed effect

Try These

• Hypothesis: If a high school biology student participates in a study group for 30 minutes every night, they will score higher on the Biology EOCT than a student that does not participate.

• What is the Independent Variable?• What is the Dependent Variable?

Try These• A high school student believes that her biology

teacher might give better test scores when she receives chocolate. Hypothesis: The more chocolate you give a teacher before she grades an exam, the better score she will give

• What is the Independent Variable?• What is the Dependent Variable?• PS. You are welcome to bring chocolate but you

wont get a better grade

Constants

• If we only test one independent variable per experiment, all other conditions must stay the same

• The conditions that stay the same during an experiment are called the constants

• What is a control group? How many control groups must every experiment have?

Experimentation

• Once you have designed your experiment, you must conduct it

• A good experiment must be conducted at least 3 times. Why?

Accuracy vs. Precision

Accuracy• The accuracy of an

experiment/object/value is a measure of how closely the experimental results agree with a true or accepted value

Precision• The precision of an

experiment/object/value is a measure of the reliability of the experiment, or how reproducible the experiment is

Example

• We measure the length of a 1 foot ruler and get values of: 13.01 in, 13.00 in, 12.99 in, 13.00 in.

• Are our results Accurate? Are they Precise?

Example

• These numbers are precise enough for us to believe that if we measure it again we would get 13.00+0.01 in.

• These measurements are precise but accurate. Why?

More on experimentation

• Data is usually quantitative

• Multiple trials

• In Biotechnology, you will almost always have two controls:– Positive control- a group of data that will give

predictable positive results– Negative control – a group of data that will give

predictable negative results

Analyzing Data

• After data collection, we must analyze the data and form a conclusion

• If the data supports the conclusion and is statistically significant then we accept the hypothesis

• If the data does not support the conclusion and is not statistically significant we reject the hypothesis

After Many Experiments

• After many experiments by different scientists, we can form a theory

• Theory: A proposed explanation for observational and experimental results that is supported by evidence– These are not proven but can be accepted– Can change over time– They are the WHY!!!!!

After Many Experiments

• Law: A mathematical statement that allows you to model the world– Tells you what will happen– Does not explain why– How is this different from a theory?

– What are some scientific laws?

More on conclusions

• REE, PE, PA Method – REE- results with evidence and explanation– PE- possible errors– PA- practical application

• How are the findings valuable to the company?• Recommendations for further experimentation

• proofread and witnessed by member not involved in experiment

Sharing Experimental Results with the Scientific Community

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

• One of the fastest growing commercial industries

• 7 out of 10 jobs posted with large companies are for laboratory technicians

• Industry will be studying DNA sequence for most of the 21st century

Careers in the Biotechnology Industry

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