1. The Biotechnology Century and Its Workforce
Chapter 1
The Biotechnology Century and Its Workforce
Welcome to Introduction to biotechnology. This class is designed to give you an overview of the biotechnology field and an introduction to the latest information and discoveries in biotechnology.

2. Define Biotechnology
The use of living organisms and biological molecules to solve problems or make useful products.
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.

3. History of Biotechnology
Fermentation
From the beginning of time, agriculture has concentrated on improving food production. The earliest and most familiar bioprocess is microbial fermentation. Fermentation is a metabolic process where by-products of glucose metabolism such as carbon dioxide and lactic acid can be used to leaven bread, make yogurt and cheese, and brew wine and beer.

4. History of Biotechnology
Selective breeding
For thousands of years humans have used an agricultural biotechnology application called selective breeding to cultivate superior crops and livestock that show an improved growth rate or other desirable traits. It is common sense to know that if you breed a male and female with a desirable trait, the offspring will all carry that trait. However, until only a few hundred years ago no one understood the biology behind this common sense.

5. History of Biotechnology
Mendel’s work in genetics
In the 1800’s Gregor Mendel began to study inheritance patterns of a common garden pea. Mendel’s observations led him to believe that some traits were “dominant” and would always be expressed, whereas other traits were “recessive” and would only be expressed if both parents exhibited this trait. Mendel’s work went largely unnoticed until the early 1900’s and has since been considered the foundation of population genetics. It is important to note that at this time no one understood that DNA was the mechanism of inheritance.

6. History of Biotechnology
Vaccinations
In the late 18th century Edward Jenner demonstrated that people injected with a live cowpox virus were immune to smallpox. How could that possibly have worked? Well, you have to understand a little bit about the immune system. Antigens are on the surface of all pathogens. A pathogen is a bacteria or virus that makes you sick. Your body reacts to these foreign antigens by stimulating white blood cells to produce antibodies that attach to the antigens on the pathogen and mark them for destruction, thereby killing all of that pathogen that is circulating in your body. However, while your body is carrying out this immune response you feel very sick. BUT some of those white blood cells become something called “memory cells” so that if your body ever encounters the same antigen again, the antibodies are ready to attack! So how did Jenner’s vaccination work to protect people from smallpox? Well, the cowpox virus is very similar to the smallpox virus. So while people who received the injection did not get sick, the injection did stimulate the immune response and the memory cells would recognize the smallpox virus if the person ever came in contact with it. Therefore, the injected people had immunity to the smallpox virus without ever becoming ill with virus. Today more than 325 million people worldwide have been helped by biotechnology derived drugs and vaccines.

7. History of Biotechnology
Pharmaceuticals
Another huge advancement for the pharmaceutical industry was the discovery of penicillin. In 1928 Alexander Fleming noticed that certain bacteria would not grow in the proximity of a particular mold. Fleming, being a typically inquisitive scientist, investigated the cause of this phenomenon. Flemings research led to the discovery and purification of the first antibiotic, penicillin. Antibiotics work by either directly killing the microorganism or by inhibiting it’s replication. Antibiotics ONLY work for bacterial infections, not for viral infections like colds. Since Flemings discovery, the biotech industry has been dominated by the discovery of new drugs. Much research has been done but we still only have a limited number of antibiotics, so it is important not to abuse them by taking them to treat viral infections which they are not effective at treating, anyway!

8. History of Biotechnology
Genetic engineering
When one thinks of modern biotechnology, however, gene engineering and recombinant organisms take center stage. Biotechnology was revolutionized when scientists first learned how to isolate and clone genes and discovered that it was possible to insert these cloned genes in a different organism and have the protein expressed. For example, scientists isolated a gene from jellyfish called the GFP gene. This gene expresses a protein that fluoresces green under UV light and is thus called the Green Fluorescent protein. Scientists have been able to clone this gene into many other organisms, including the fish in this picture, and when the GFP gene is expressed these organisms glow green under UV light! The remainder of this module will explain this exciting biological revolution.

9. Relating Biotechnology to Current World Issues
Biotechnology is used in:
Agriculture – reducing the use of harmful pesticides
Bioremediation – cleaning up the environment
Food Processing – genetically modified food
Textile industry– enzymes replacing harmful chemicals
Forensics – criminal investigations
Archeology – determine ancestry of mummies and fossils
Medicine – cheaper medicines and diagnostic tests
The purpose of this online curriculum is to show you that regardless of where your interests lie, there is an application for biotechnology. The chart above is merely the tip of the iceberg regarding biotechnology applications in the fields of agriculture, environmental bioremediation, food processing, textile industry, forensics, archeology, and the medical field. The remainder of this module will help you understand the basic concepts of biotechnology so that we can explore the applications listed above in the next 2 modules and help you figure out a way to integrate biotechnology concepts into your classroom.

10. Introductory Biotech Video
                              
                              
                              
                                 
This slide is a collage of some topics you have heard about on the news. Biotechnology encompasses a number of controversial topics such as cloning, stem cell research, using animals in research, genetically modified food, and creating “designer babies”. Click on the link to the Introductory Biotech Video to further your understanding of the applications in this exciting field.
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11. Biotechnology: A Science of Many Disciplines
Basic sciences form the roots for biotech

12. Distribution of US Biotech Companies
There are over 1500 biotech companies in the US and the industry employs over 200,000 people.

13. Jobs in Biotechnology
Let’s look around a typical biotechnology company and see what kinds of jobs are available.

14. Organization of a Biotech Company
The exact organization of a biotechnology company depends on what type of company it is: whether it is marketing a service or a product, whether it is marketing agricultural, medical, environmental, forensics, or research products. Biotech companies also vary in size, but most share a similar organizational structure. Let’s first visit Research and Development (R&D for short).

15. Organization of a Biotech Company
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
Development of a new biotech product is a long and expensive process and it all begins with the Research and Development department. This department researches ideas for new products. The potential product then goes through a period of development during which the idea is transformed into an actual workable and most importantly marketable product.

16. Organization of a Biotech Company
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
The procedure or protocol that has been developed by R&D for making this new product is then handed over to the production department. The protocol goes through rigorous testing and modifications so that it can be scaled up to larger quantities. It would be analogous to using a recipe designed to feed a family of four and modifying it to cater a banquet for 200 people. Modifications must be made so that the product is made in a consistent, reproducible, and economically efficient way. The production department is also responsible for the routine maintenance and calibration of the equipment they use to produce the product.

17. 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
As a product moves through its lifecycle from development into production, the tasks of the quality control (QC) and quality assurance (QA) departments mature along with it. Quality Control is the department that is responsible for maintaining the quality of the product. A QC technician tests a sample from every lot before it is sent out to ensure the customer receives a quality product. The Quality Assurance department plays a key role during development and production of a new product. QA monitors all of the paperwork associated with a product to ensure it is complete and accurate. QA is also responsible for investigating and correcting potential problems and assuring all procedures adhere to the company’s standard requirements.

18. 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
There are a number of support departments that are critical to the lifecycle of a new biotech product. Once the product has been made in the production department it must be dispensed into individual containers for customer use, packaged, and shipped to the customer. There are also numerous employees at biotech companies that maintain and calibrate equipment and manage repairs and housekeeping duties. Without each of these employees, the company could not produce a successful product.

19. 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
An amazing new product amounts to nothing if it is not profitable for the company. Employees in business services are responsible for marketing and selling the product to new clients. An understanding of the science behind the product they are selling is essential to a successful marketing campaign. The accounting department oversees the company’s finances and are often involved in raising funds from partners or venture capitalists seeking to invest in a biotech company. Finally, a good customer service department is critical to a successful company. This department answers all customer inquiries and complaints about the product and also addresses technical questions about the use of the product.

20. 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
Food and Drug Administration (FDA) – regulates the safety of genetically modified food and pharmaceutical products
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
Environmental Protection Agency (EPA) – regulates environmental release of genetically modified organisms
Most products from biotech companies are very highly regulated by three government agencies, the FDA, the USDA, and the EPA. A biotech company’s Regulatory Affairs department is responsible for ensuring compliance with all federal regulations. Depending on the product being manufactured, it can be regulated by one or all three government agencies. The FDA regulates genetically modified food and all new drugs, therapies, and medical diagnostic tests. The USDA regulates genetically modified meat, poultry, eggs and plants. The EPA monitors the effects of genetically modified organisms on the environment. These agencies mandate strict adherence to federal guidelines and if a company does not comply it can be fined or even shut down.

21. Organization of a Biotech Company
Virtual Tour of a Biotech Company
As you can tell, the design and marketing of a new biotech product is quite complex, but it all begins with critical thinking and good problem solving skills. Click on the link to take a virtual tour of a company in Austin, TX that manufactures products related to RNA research.