• Biotechnology is the study and manipulation of living things or their component molecules, cells, tissues, or organs for the benefit of humans (or other animals).
– This term has been used since the 1970’s to reflect the application of exciting new technologies to the research and development of products from plant and animal cells.

(but is not limited to)
• Recombinant DNA (rDNA) technology
• Polymerase Chain Reaction (PCR)
• Cloning
• Fermentation
• The creation of
– Insulin to treat diabetes
– Proteases (enzymes used to remove stains from clothing)
– Antibodies (for recognizing and fighting certain diseases
– Selective Breeding (dog breeds, flowers, fruits)
– Pharmaceutical drugs
– Cellular manipulation products (growing human ears on mice)

• Human ears are sometime lost through accidents. Mouse cells can be “tricked” into growing the outer portion of the human ear, which is then surgically transferred to the human patient.
http://www.youtube.com/watch?v=PEc7QXAjsL4&feature=fvsr

In 1997 Scientists at the
Rosalind Institute in
Scotland announced that they had cloned a sheep they had named “Dolly”.
Dolly was created by transferring the nucleus of a mammary cell from an udder to an egg.
The Clone Age (part1)

• Historical accounts have shown that the Chinese, Greeks, Romans,
Babylonians, and Egyptians (among many others) have been involved in Biotech since 2000 BC!
• Early ancestors took advantage of microorganisms and used fermentation to make breads, cheeses, yogurts, and alcoholic beverages such as beer and wine.

Fermentation is when strains of yeast decompose sugars to derive energy, and in the process they produce ethanol (alcohol) and carbon dioxide as a waste product.
– When bread dough is being made, added yeast
( saccharamyces cerevisiae ) ferments sugar releasing carbon dioxide, which causes the dough to rise and creates holes in the bread. The alcohol produced by the yeast evaporates when the bread is cooked.
– When making cheese, added bacteria undergo fermentation by breaking down Lactose (milk sugar) and converting it to Lactic Acid which causes the milk to curdle and form cheese!
•  WE WILL BE DOING THIS 

• For thousands of years, humans have used selective breeding .
– Selective Breeding: Organisms with desirable features are purposely mated to produce offspring with the same desirable characteristics .

• In 500 BC the Chinese used moldy curds as an antibiotic to treat boils
• 100 BC: Chinese use powdered chrysanthemum as an insecticide

• In 1928 Alexander Fleming discovered that mold
Penicillium inhibited the growth of Stapholococcus aureus. His discovery came from a pile of
“contaminated” Petri dishes.
Learn More about Fleming!
MRSA
(pic of a sore)

Edward Jenner was an English country doctor who pioneered vaccination. Jenner's discovery in 1796 that inoculation with cowpox gave immunity to smallpox, was an immense medical breakthrough and has saved countless lives.
See Jenner’s Story!

• In 1972 the DNA composition of humans is shown to be 99% similar to that of chimps and gorillas
• In 1981 the first genetically-engineered plant is reported and the 1st mouse was successfully cloned
• In 1982 Humulin (a human insulin drug), was produced by genetically-engineered bacteria and was the first biotech drug approved by the FDA

• In 1994 the first breast cancer gene is discovered
• In 1996 scientists clone identical lambs from early embryonic sheep
• In

• The Human Genome Project (HGP) was an international, 13 year effort that began in 1999 and was completed in 2003.
The project goals were to
• Determine the complete sequence of the 3 billion
DNA subunits (bases)
• Identify all human genes, and make them accessible for further biological study.
– As part of the HGP, parallel sequencing was done for selected model organisms such as the bacterium E.coli
to help develop the technology and interpret human gene function.
Mapping the Human Genome Video Clip

• Biotechnologists work in a variety of settings, including corporate labs, government agencies/ labs, and academic (college and university) research facilities.
• Biotechnology is a broad field that includes the domains of medicine and pharmaceuticals, agriculture, industry, the environment, instrumentation, and diagnostics

The domain areas in Biotechnology can be simplified into eight different concentrations
1. Microbial
2. Agricultural
3. Animal
4. Forensic
5. Bioremediation
6. Aquatic
7. Medical
8. Regulatory

• Microbial Biotechnology: The manipulation of microorganisms such as yeast and bacteria.
Example: Fermentation
• Agricultural Biotechnology: The genetic engineering of plants in hopes of
– Giving the plant pest resistance
– Producing foods with a higher protein or vitamin content
– Developing drugs that can be grown and isolated in plant products
What is Agricultural Biotechnology

• Animal Biotechnology: This branch includes
– Using animals as a source of medically valuable proteins
• Antibodies
– Using animals as an important model in basic research
• Gene “knockout” experiments (where genes have been turned off)
• Designs and testing of drugs and genetic therapies
– Animal cloning
• Source of transgenic organs (animal organs that can be transplanted into humans without fear of rejection).

• Forensic Biotechnology
– DNA fingerprinting
• Inclusion or exclusion of a person from suspicion
• Paternity cases
• Identification of human remains
• Endangered species
• Tracking and confirmation of the spread of disease
• Bioremediation
(video clip)
– The use of biotechnology to process and degrade a variety of natural and manmade substances
• Particularly those that contribute to pollution
– For example, bacteria that degrade components in crude oil
• 1989 Exxon Valdez oil spill in Alaska
• Gulf Oil Spill

• Aquatic Biotechnology
(video clip)
– Aquaculture – raising finfish or shellfish in controlled conditions for use as food sources
• 30% of all fish consumed by humans worldwide
– Genetic engineering
• Disease-resistant strains of oysters
– Vaccines against viruses that infect salmon and other finfish
– Rich and valuable sources of new genes, proteins and metabolic processes with important applications for human benefits
• Marine plankton and snails found to be rich sources of antitumor and anticancer molecules

• Medical Biotechnology
• Involved with the whole spectrum of human medicine
• Preventive medicine
• Diagnosis of health and illness
• Treatment of human diseases
• New information from Human Genome Project
• Gene therapy
• Stem cell technologies
• Regulatory Biotechnology
– Quality Assurance (QA)
• All activities involved in regulating the final quality of a product
– Quality Control (QC)
• Part of QA process that involves lab testing and monitoring of processes and applications to ensure consistent product standards

• Products developed through biotechnology must have a market large enough to generate the profit required to fund future research and development
• To begin research and development on a potential product, companies must have satisfactory answers to such questions as, “Who will use the product?”,
“Is it economical to produce?”
• Stages in product development (product pipeline) include product identification, research and development, small-scale manufacturing
(fermentation), testing for safety and efficacy
(including clinical trials), manufacturing, and sales and marketing.

• Biotechnology is a global industry
– Generates more than $63 billion in worldwide revenues
– $40 billion in sales of biological drugs in the United
States

• Some discoveries may or may not lead to product development, but the information contributes to our scientific knowledge.
This is considered “pure science.”
• Although the discovery process and product pipelines are different for every product, it usually takes 10 to 15 years to bring a product to market .
(Some products take longer to come to market, particularly pharmaceuticals that must undergo clinical trials).
• Agencies that regulate the development and approval of biotechnology products include the FDA, the USDA, and the EPA .

• During the 2012 Super Bowl, a representative of the pharmaceutical company Eli Lilly posted on the company’s corporate blog that the average cost of bringing a new drug to market is $1.3 billion , a price that would buy 371 Super Bowl ads, 16 million official NFL footballs, two pro football stadiums, pay of almost all NFL football players, and every seat in every NFL stadium for six weeks in a row. This is, of course, ludicrous.
• The average drug developed by a major pharmaceutical company costs at least $4 billion, and it can be as much as $11 billion .

All scientists follow a set of procedures to answer their scientific questions. Most follow a scientific methodology that begins with
1.
Ask a testable question or state a problem based on some information or observation
2.
Predict the answer and develop a testable hypothesis
3.
Plan and conduct a valid experiment that includes
 on experimental data and error A single manipulated variable
 Control groups (both + and -)
4.
Collect and analyze measurable data
5.
Report their findings and discoveries by formulating a conclusion based analysis.

Massachusetts has the highest educated workforce in the United States. It ranks 1st in the nation in percentage of residents with a bachelors degree or higher. Its elementary and secondary students perform best in the nation on national assessments.
• There are 49,825 biopharma employees in
Massachusetts (2011 estimate) and the companies employing those workers are responsible for over $4.6 billion of in-state payroll.

• The Massachusetts biopharma industry grew by
53% between 2002 and 2011.
Source: U.S. Bureau of Labor Statistics, County Business Patterns and MassBio analysis

• Most jobs at a biotechnology company are in the following areas: research and development, manufacturing and production, clinical research, quality control, information systems, marketing and sales, regulatory affairs, and administration/legal affairs.
• Many laboratory positions require a minimum of a
4-year college degree. Manufacturing and quality control staff need either a 2- or 4-year degree . A scientific background is helpful for nonscientific employees as well.