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Chapter 6
Learning Outcomes
Give examples of biotechnology products derived from plant and animal sources and discuss the challenges of extracting compounds Identify the steps in a Comprehensive Product Development Plan and use it to determine whether a potential biotechnology product is worth manufacturing Discuss the types of assays done as potential products move through process development and identify the additional assays required for pharmaceutical development Explain how scientists test the effectiveness of antibiotics and antimicrobials and discuss the significance of antibiotic resistance. Describe the role of CHO cells in protein product development Describe the typical recombinant DNA protein product pipeline, additional steps required by the FDA for pharmaceutical proteins, and possible formulations of the final product
For thousands of years, people have used plant and animal organs for many purposes.
Recently, scientists have learned how to use plant and animal parts as sources of products:
Pancreas of livestock is used to make insulin. Foxglove plant is used to regulate irregular heartbeat.
Vocabulary
Amylase an enzyme that functions to break down the polysaccharide amylose (plant starch) to the disaccharide maltose
Assay a test
1. 2. 3. 4.
Why are antibiotics important biotechnology products? What is the function of the enzyme, amylase? Why might a company be interested in producing amylase as a product? Summarize the criteria that a potential product must meet in a CPDP review.
If a substance is chosen as a potential product, researchers must be able to test for its presence, activity, and concentration. The product must be assayed. Other assays are done for potency, toxicity, and stability. Assays are performed at every step in the development of a product.
The 24-well plate reveals samples with different amounts of amylase activity. Amylase breaks down starch to sugar. In the activity assay, as amylase breaks down starch, the dark color of a starch/iodine mixture becomes lighter. The lighter the color, the more active the amylase.
Decreasing amounts of protein are indicated by less blue color in the tube. The right-hand tube is a negative control that contains no protein. The tubes to the left are 0.01, 0.1, and 1 mg/mL, respectively.
Vocabulary
Activity assay an experiment designed to show a molecule is conducting the reaction that is expected Concentration assay a test designed to show the amount of molecule present in a solution Investigational New Drug (IND) documented procedure indicating the status of a drug after the FDA has approved that it can be tested on humans Pharmacodynamic (PD) assay experiment designed to show how a drug is metabolized (processed) in the body Potency assay experiment designed to show the biochemical effect of a drug on the body Toxicology assay experiment designed to find what quantities of a drug are toxic to cells, tissues, and model organisms Stability assay experiment designed to determine the conditions that affect the shelf life of a drug
1. 2.
What kind of assay would use Bradford reagent in the test? For what purpose would a technician use an ELISA?
3.
4.
Vocabulary
Herbal remedies products developed from plants that exhibit or are thought to exhibit some medicinal property Antimicrobial a substance that kills or slows the growth of one or more microorganisms Antiseptic antimicrobial solution, such as alcohol or iodine, that is used to clean surfaces
1. 2. 3. 4.
From where do scientists expect that most of the remaining naturally occurring biotechnology products will come? How can a technician know if a certain type of bacteria is sensitive to an antimicrobial substance? List a few herbal products that claim to have therapeutic value against depression. How can molecules be extracted from plant samples for testing purposes?
Plant Characteristics
Phenotypes are the observable expressions of genes. Spherical is a phenotype. Dented is another phenotype. Phenotypes result from the presence or lack of specific proteins.
Vocabulary
Phenotype the characteristics observed from the expression of genes, or genotype Genotype the genetic makeup of an organism; the particular form of a gene present for a specific trait Genetically modified organism an organism produced by genetic engineering Cellulase an enzyme that weakens plant cell walls by degrading cellulose Pectinase an enzyme that weakens plant cell walls by degrading pectin Protoblast a cell in which the cell wall has been degraded and is surrounded by only a membrane Macerated crushed, ground up, or shredded
1. 2.
Distinguish between phenotype and genotype using examples. What does GMO stand for? Explain how Monsanto Canada, Incs Roundup Ready soybeans are an example of a GMO. What is the most challenging part about trying to isolate plant DNA or plant proteins from cells? Of what value are plant cell protoplasts?
3. 4.
Vocabulary
Transfection genetic engineering, or transformation of mammalian cell lines Formulation the form of a product, as in tablet, powder, injectable liquid, etc.
1. 2.
What are CHO cells and what are they used for? How long does it take to develop, test, and market a typical rDNA protein product?
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4.