1. Introduction to the Biotechnology Workplace
Biotechnology and the workplace

2. What is Biotechnology?
It is the use of organisms, or materials derived from organisms, to make useful products.
Thousands of years old
Bread making
Wine making
Cheese making
We refer to cloned sheep, gene therapies, DNA fingerprinting

3. Molecular Biology
DNA-genetic substance by which parents pass info to their offspring (4 nucleotides)
GENE: ordered sequence of nucleotides containing genetic info on how to make a particular protein
CHROMOSOME: cell containing many organized genes (X, Y, 2*23, Procaryotic/Eucaryotic cells)
DNA > mRNA > Protein

4. What is technology?
It is the application of scientific knowledge to make products useful to humans.
It is also the application of knowledge about living systems in ways useful to humans

5. Technologies of Modern Biotechnology
Genetically engineered is a term meaning that a biologist makes a cell take up a gene from another cell.
Recombinant DNA is a term meaning that the DNA contains sequences from different sources of DNA
DNA contains codes that direct the cell to make proteins. DNA > mRNA > Pritein
When the protein is produced by a cell it is expressed.

6. Continued
DNA can be transferred to recipient cells in a number of ways.
Genes may be spliced into plasmids
Plasmids which carry genes into recipient cells are called vectors
Plasmids are small, circular molecules of DNA found in many types of bacteria, which exists separately from the bacterial chromosome.

7. Fermentation Used to cultivate microorganisms
Bacteria cells were induced to express the human insulin gene.
This bacteria containing the human insulin gene can be grown in large quantities
The insulin can be isolated and used to treat diabetes.
Fermenter vs. Bioreactor (p8)

8. Culturing of cells
Are grown in flasks, dishes, vats, and other containers outside a living organism
The gene of interest can be introduced into mammalian cells that can produce a desired protein
Mammalian cells produce this protein more slowly and have greater nutritional requirements than do bacteria

9. Continued
Genes of interest may also be introduced into plants and animals
A plant or animal whose cells are genetically modified using the techniques of Biotechnology is called transgenic
Growth hormones can be introduced into a fertilized egg to cause the offspring to have the hormone in all cells.
What problems could arise from genes given to a mouse to enhance growth, being passed on to its offspring?
Some Genetic therapies will treat an illness and not be passed on the offspring and not affect other areas of the body.

10. Monoclonal Antibodies
Antibodies are proteins, made by the immune system, that recognize and bind to substances invading the body
An antibody will bind to only one target
Monoclonal antibodies have found many applications in research and in medical diagnosis
Home pregnancy kits (HCG): Human Chorionic gonadotropin
Monoclonal antibodies are exceptionally homogeneous populations of antibodies directed against a specific target
They are produced by hybridoma cells that result from the fusion of an antibody-producing cell and a cultured cell

11. Applications of Biotechnology
Medical/Veterinary Applications
Biopharmaceuticals
Gene therapy
Agricultural/Food applications
Genetically modified foods
Other applications
Identification of individuals
Biopharmaceuticals are pharmaceutical products, like insulin, that are manufactured using genetically modified organisms as production systems
Gene therapy involves replacing a gene that is missing, or correcting the function of a faulty gene, in order to treat or cure an illness

12. Organization of a Biotech Company
Research and Development
Finds ideas for products, performs research and testing and develops ideas into products
Production
Produces the products developed by R&D
Quality Control/Quality Assurance
Monitors processes and tests products
Other Functions in a Company
“Cultures” within a Company

13. Responsibilities of R&D
Identify products of commercial value
Identify properties of products
Establish product specifications
Develop testing methods
Develop process to make the product
Describe cells or organism needed
Determine Raw materials
Determine equipment needs
Develop a plan for production of product

14. Responsibilities of Production
Making the product
Working with large scale equipment and large volume reactors
Monitoring and control of environment required for product
Cleaning, calibration, and cleaning of eq.
Following written procedures and performing tasks related to production

15. Continued Monitoring processes associated with making the product
Initiating corrective actions in needed
Completing forms, labeling, filling in logbooks, and maintaining other required documents

16. Responsibilities of QA/QC
Monitoring equipment, facilities, environment, personnel, and product
Reviewing all production procedures
Ensuring that all documents are accurate, complete, and available
Testing samples of the product and raw materials for acceptability
Comparing data to established standards

17. Continued
Deciding whether or not to approve the product for release to consumers
Reviewing customer complaints

18. Other Functions in a Company
Engineering
Facility maintenance and housekeeping
Receiving and shipping
Dispensing
Metrology
Marketing and Sales
Metrology assures that instruments in lab and production operate properly

19. Cultures within the company
R&D in an atmosphere of change and unpredictability
Production in a predictable environment
QC intent on quality assurance
In small companies the differences between these three are often blurred!!!