C HAPTER 1: W HAT IS B IOTECHNOLOGY ? Introduction to Biotechnology, BIOL1414 Austin Community College, Biotechnology Dept

L EARNING O UTCOMES Define biotechnology, provide examples of biotechnology products Give examples of careers and job responsibilities associated with biotechnology Describe how scientific methodologies are used to conduct experiments and develop products Define and apply bioethics

D EFINING B IOTECHNOLOGY  Biotechnology is defined as the study and manipulation of living things or their component molecules, cells, tissues, or organs.

T HE H ISTORY OF B IOTECHNOLOGY We think of biotechnology as a relatively new field of science, but the word “biotechnology” was first used in 1919 by a Hungarian engineer. He used it to describe using another living organism for one’s own benefit. By this definition, biotechnology is not new. In fact, it dates all the way back to the very beginnings of civilization. Fermentation:

Biotechnology is used in:  Agriculture – reducing the use of harmful pesticides  Bioremediation – cleaning up the environment  Food Processing – genetically modified food  Forensics – criminal investigations  Archeology – determine ancestry of mummies and fossils  Medicine – cheaper medicines and diagnostic tests R ELATING B IOTECHNOLOGY TO C URRENT W ORLD I SSUES Explore! Click here! Explore! Click here! What is Biotechnology? What is Biotechnology?

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V OCABULARY  DNA – abbreviation for deoxyribonucleic acid, a double- stranded helical molecule that stores genetic information for the production of all of an organism’s proteins  Recombinant DNA (rDNA) technology – cutting and recombining DNA molecules  Polymerase chain reaction (PCR) – a technique that involves copying short pieces of DNA and then making millions of copies in a short time  Cloning – a method of asexual reproduction that produces identical organisms  Proteases – proteins whose function is to break down other proteins  Antibodies – proteins developed by the immune system that recognize specific molecules (antigens)  Pharmaceutical – relating to drugs developed for medical use

THE B IOTECHNOLOGY W ORKPLACE  Biotechnology Companies - goal is to produce and sell commercial “for- profit” products  Universities and Government Labs - conduct “pure science” research, nonprofit

D OMAINS OF B IOTECHNOLOGY

L OOKING A HEAD  Science and Business of Biotechnology  Basic Biology &Chemistry Concepts  Recombinant Protein Product  Applications of Biotechnology in Agriculture & Pharmaceuticals  Recent Advances in Biotechnology

V OCABULARY  Research and development (R&D) –the early stages in product development that include discovery and initial small- scale production  Virus – a particle containing a protein coat and genetic materials (DNA or RNA) that requires a host to replicate  Applied science – the practice of utilizing scientific knowledge for practical purposes, including the manufacture of a product  NIH –National Institutes of Health; the federal agency that funds and conducts biomedical research  CDC –Centers for Disease Control and Prevention; developing and applying disease prevention and control, environmental health, and health promotion  DNA fingerprinting – an experimental technique that is commonly used to identify individuals by distinguishing their unique DNA code

T HE I NCREASING V ARIETY OF B IOTECHNOLOGY P RODUCTS In the past 100 years, scientists have increased the pace of searching for products that improve the quality of life.  Antibiotics  Industrial products such as rubber, turpentine, and maple syrup Bioengineered Products  As the methods of manipulating living things have become more sophisticated, the number and variety of biological products have increased at an incredible rate.

G ENETICALLY MODIFIED ORGANISMS  Genetically modified organisms – organisms that contain DNA from another organism and produce new proteins encoded on the acquired DNA  Genetically Engineered Plant. Scientists have learned how to move genes that code for certain traits and transfer them from one species to another.

P RODUCING R ECOMBINANT P ROTEIN  Humans make only a small amount of tissue plasminogen activator 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.

T HE H UMAN G ENOME P ROJECT  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

V OCABULARY  Antibiotics – molecular agents derived from fungi and/or bacteria that impede the growth and survival of some other microorganisms  Restriction enzyme – an enzyme that cuts DNA at a specific nucleotide sequence  DNA ligase – an enzyme that binds together disconnected strands of a DNA molecule  Recombinant DNA (rDNA) – DNA created by combining DNA from two or more sources  Genetically modified organisms (GMO) – organisms that contain DNA from another organism and produce new proteins encoded on the acquired DNA  E. coli – a rod-shaped bacterium native to the intestines of mammals; commonly used in genetics and biotechnology

D EVELOPING I DEAS FOR N EW P RODUCTS 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 Ideas come from many sources:  Discussions lead to new ideas  Reading literature reviews can lead to new ideas  Sometimes even daydreaming can lead to new ideas

R ESEARCH AND D EVELOPMENT Vocabulary  Reagent – a chemical used in an experiment  Large-scale production – the manufacture of large volumes of a product  Clinical trials – a strict series of tests that evaluates the effectiveness and safety of a medical treatment in humans  Therapeutic – an agent that is used to treat diseases or disorders

R ESEARCH AND D EVELOPMENT Vocabulary  FDA –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  EPA –Environmental Protection Agency; the federal agency that enforces environmental laws including the use and production of microorganisms, herbicides, pesticides, and genetically modified microorganisms  USDA –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

A P RODUCT D EVELOPMENT P LAN  Before going into research and development, company officials must determine whether or not it is worth the investment of company resources.  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?

R EGULATIONS G OVERNING P RODUCT D EVELOPMENT New Biotech Drug Approvals. There were 35 new approvals in 2011 (FDA.gov).

D OING B IOTECHNOLOGY : S CIENTIFIC M ETHODOLOGY IN A R ESEARCH F ACILITY Students are often taught that there is a “scientific method.” Conducting an Experiment Using Scientific Methodologies 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 the data into tables, charts, graphs, or graphics. 5. Formulate a conclusion based on experimental data and error analysis.

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D EVELOP A TESTABLE HYPOTHESIS Diluting Bleach Hypothesis. Higher concentrations of bleach should cause more color fading.

C OLLECTING D ATA  Data Table and Graph. Observations and measurements are reported in data table. Individual trials (replications) as well as averages are shown.  Numerical data are shown in picture form using graphs.

S HARING E XPERIMENTAL R ESULTS WITH THE S CIENTIFIC C OMMUNITY Once an experiment is complete, the work is reported to others through:  Publications  Presentations  Annual conferences

V OCABULARY  Data – information gathered from experimentation  Hypothesis – an educated guess to answer scientific question; should be testable  Variable – anything that can vary in an experiment; the independent variable is tested in an experiment to see its effect on dependent variables  Concentration – the amount of a substance as a proportion of another substance; usually how much mass in some amount of volume  Journals – scientific periodicals or magazines in which scientists publish their experimental work, findings, or conclusions

V OCABULARY  Control – an experimental trial added to an experiment to ensure that the experiment was run properly; see positive control and negative control Positive control – a group of data that will give predictable positive results Negative control – a group of data that will give predictable negative results

C AREERS IN B IOTECHNOLOGY

C AREERS IN THE B IOTECHNOLOGY I NDUSTRY  One of the fastest growing commercial industries  Career opportunities in: Bioscience: Medical, Agricultural, Environmental Applied chemistry Physics Computer science  Industry will be studying DNA sequence for most of the 21 st century

T YPICAL J OBS & D EGREE R EQUIREMENTS IN B IOTECHNOLOGY

C AREERS IN THE B IOTECHNOLOGY I NDUSTRY  Bachelor of Science Degree  Biochemistry  Molecular biology  Genetics  2-year college degree  High school specialization  More advanced degrees  Master of Science  Master of Arts  Doctor of Philosophy  Postdoctoral research experience Employees in nonscientific positions must have an interest in and understanding of the science of biotechnology. Sales Marketing Regulatory Legal Financial Human resources Administrative staff Scientific Educational Requirements Nonscientific Educational Requirements

O RGANIZATION OF A B IOTECH C OMPANY

 Research and Development Organizational unit in a company that finds ideas for products Directly involved in designing and running experiments to see if the ideas are feasible Responsible for developing promising ideas into marketable products

 Production/Manufacturing Manufactures products that have been given to them by R&D Often involves scale-up of protocols Routine cleaning, calibration and maintenance of equipment Organization of a Biotech Company

 Quality Assurance/ Quality Control Monitors and checks final products for quality before they are sent to the consumer Compares data to established standards Maintains documentation Organization of a Biotech Company

 Support Departments Filling and packaging bulk products in individual containers for customer use Metrology ensures instruments are operating properly Facilities technicians maintain critical day to day functions such as housekeeping and repairs Organization of a Biotech Company

 Business Services Marketing and sale of the product Accounting department manages financial reports Customer service interacts with customers to address questions and complaints Organization of a Biotech Company

 Regulatory Affairs Many products are regulated by government agencies and a regulatory affairs staff is needed to interpret the rules and ensure compliance with these three federal agencies 1. Food and Drug Administration (FDA) – regulates the safety of genetically modified food and pharmaceutical products 2. U.S. Department of Agriculture (USDA) – regulates the purity and quality of meat, poultry and eggs and monitors safety of genetically modified food and plants 3. Environmental Protection Agency (EPA) – regulates environmental release of genetically modified organisms Organization of a Biotech Company

J OBS IN B IOTECHNOLOGY

Organization of a Biotech Company Explore! Click here! Explore! Click here! Careers in Biotechnology Careers in Biotechnology Watch this video! Watch this video! Cool Biotech Jobs in Austin! Cool Biotech Jobs in Austin! Explore! Click here! Explore! Click here! Tour of a Biotech Company Tour of a Biotech Company Watch this video! Watch this video! Cool Careers in Biotechnology! Cool Careers in Biotechnology!

V OCABULARY Genome – one entire set of an organism’s genetic material (from a single cell) Biochemistry – the study of the chemical reactions occurring in living things Molecular biology – the study of molecules that are found in cells Genetics – the study of genes and how they are inherited and expressed

B IOTECHNOLOGY WITH A C ONSCIENCE - B IOETHICS  How do we learn what is right and wrong behavior?  As new situations arise in your life, how do you decide what is acceptable behavior and what is unacceptable? Moral Standards  Being able to distinguish between right and wrong and to make decisions based on that knowledge is considered “having good morals.”  The study of moral standards and how they affect conduct is called ethics.  New technologies generate ethical questions that cannot be answered using scientific methods.  Products are regulated by FDA, USDA, and EPA.

E THICS  Identify and understand the problem or issue. Learn as much as possible about the issue.  List all possible solutions to the issue.  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.  Based on the pros and cons for each solution, rank all solutions from best to worst.  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

Q UESTIONS AND C OMMENTS ?

R EVIEW Q UESTIONS Your Turn! Put your name at the top of a sheet of paper, answer these questions and hand in: 1.What is biotechnology? 2.Give an example of a biotechnology product that helps to improve your life. 3.What group of potential products must be tested in clinical trials before it can be marketed? 4.Scientific methods used by scientists vary from lab to lab and situation to situation. One approach to scientific studies is to follow a five-step process in which a question is asked and answered. Outline these five steps. 5.Why do valid experiments contain many trials repeating the same version of an experiment? 6.In a conclusion, evidence for statements must be given. Describe the kind if evidence that is given in a conclusion statement. 7.What area of biotechnology are you currently interested in getting a job? 8.Define the term “bioethics.”