What is Biotechnology ? Chapter 1

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

1.1 Defining Biotechnology Biotechnology is defined as the study and manipulation of living things or their component molecules, cells, tissues, or organs.

Vocabulary Insulin – a protein that facilitates the uptake of sugar into cells from the blood 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 Fermentation – a process by which, in an oxygen-deprived environment, a cell converts sugar into lactic acid or ethanol to create energy Diabetes – a disorder affecting the uptake of sugar by cells, due to inadequate insulin production or ineffective use of insulin 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

Biotechnology Workers and the Biotechnology Workplace Biotechnology Companies - goal is to produce and sell commercial “for-profit” products Universities and Government Labs - conduct “pure science” research, nonprofit Growth in the Biotechnology Industry

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

Looking Ahead  Science and Business of Biotechnology  Basic Biology and Chemistry Concepts  Recombinant Protein Product  Applications of Biotechnology in Agriculture and Pharmaceuticals  Recent Advances in Biotechnology

Vocabulary 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 Pure science – scientific research whose main purpose is to enrich the scientific knowledge base Virus – a particle containing a protein coat and genetic materials (either DNA or RNA) that is not living and requires a host to replicate Applied science – the practice of utilizing scientific knowledge for practical purposes, including the manufacture of a product NIH – abbreviation for National Institutes of Health; the federal agency that funds and conducts biomedical research 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 DNA fingerprinting – an experimental technique that is commonly used to identify individuals by distinguishing their unique DNA code

1.1 Review Questions 1.What is biotechnology? 2.Name a biotechnology product that has a medical use. 3.Besides biotechnology companies, where can biotechnologists work? 4.Biotechnology companies are grouped into four categories based on the products they make and sell. Name the four categories of products.

Lab Books

1.2 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. Antibiotics -> such as penicillin, amoxicillin, carbenicillin. Cipro – strong enough to kill any bacteria including anthrax 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. Example- use of restriction enzymes to cut DNA into pieces. Using DNA ligase for pasting the pieces together in a new modified order.

Genetically modified organisms – organisms that contain DNA from another organism and produce new proteins encoded on the acquired DNA Gene 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.

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.

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

1.3 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 Products 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

A 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. 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.

Research and Development (R & D) Often requires several years Because the drug must demonstrate ‘proof of concepts’ data Does it really work? Does it do what it’s supposed to do? Did it pass clinical studies? It could take 10 years for R&D to work out the process for making and testing a product. After that it could take 5+ years to conduct all the clinical trials/testig

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 There were 24 new approvals in 2008.

Today Notes Questions Vocab Tomorrow Lab

1.4 Doing Biotechnology: Scientific Methodology in a Research Facility Conducting an Experiment Using Scientific Methodologies 1.State a testable scientific question or problem based on some information or observation. - Ask a question that is testable 2.Develop a testable hypothesis. - Must be able to test in lab setting with equipment available 3.Plan a valid experiment. - Follow given procedures 4.Conduct the outlined experiment and collect and organize the data into tables, charts, graphs, or graphics. -Write down anything that happens during the lab -Color changis -Bubbles formed -Errors that may have happened 5.Formulate a conclusion based on experimental data and error analysis. -Restate facts found from the lab to support your conclusion -Use evidential research to help support your conclusion

Develop a testable hypothesis Diluting Bleach Hypothesis. Higher concentrations of bleach should cause more color fading.

Retesting an Experiment Once a test is completed it must be retested Why? Need to make sure that the product of the test is reproducible and not just a one time fluke Need to make sure that experimental process can be followed by others

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 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 1.5 Careers in the Biotechnology Industry

Educational Requirements 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 Nonscientific Positions and Educational Requirements 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

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

1.6 Biotechnology with a Conscience - Bioethics 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.

Strategy for Values Clarification 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.