Transcript Identifying a Potential

Identifying a Potential
Biotechnology Product
Chapter 6
Learning Outcomes
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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
6.1 Sources of Potential Products
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:
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Pancreas of livestock is used to make insulin.
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Foxglove plant is used to regulate irregular heartbeat.
Harnessing the Potential of Materials Produced in Nature
Sometimes a product is made in very small quantities in nature so it must be produced
Modeling the Research and Development of a Potential Product
Estimating market size
Identifying product sources
Creating a Comprehensive Product Development Plan (CPDP)
1. Does the product meet a critical need? Who will use the product?
2. Is the market large enough to produce sufficient sales? How many customers are
there?
3. Does preliminary data support that the product will work? Will it do what the company
claims?
4. Can patent protection be secured? Can the company prevent other companies from
producing it?
5. Can the company make a profit on the product? How much will it cost to make it? How
much can it be sold for?
Vocabulary
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Amylase – an enzyme that functions to break down the polysaccharide amylose
(plant starch) to the disaccharide maltose
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Assay – a test
6.1 Review Questions
1.
Why are antibiotics important biotechnology products?
2.
What is the function of the enzyme, amylase?
3.
Why might a company be interested in producing amylase
as a product?
4.
Summarize the criteria that a potential product must meet
in a CPDP review.
6.2 The Use of Assays
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
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Activity assay – an experiment designed to show a molecule is conducting the
reaction that is expected
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Concentration assay – a test designed to show the amount of molecule present in
a solution
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Investigational New Drug (IND) – documented procedure indicating the status of
a drug after the FDA has approved that it can be tested on humans
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Pharmacodynamic (PD) assay – experiment designed to show how a drug is
metabolized (processed) in the body
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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
6.2 Review Questions
1.
What kind of assay would use Bradford reagent in the test?
2.
For what purpose would a technician use an ELISA?
3.
What does a stability assay measure?
4.
In a large company, which department would have several
employees developing and conducting assays?
6.3 Looking for New Products in Nature
Herbal remedies from the rainforest
Vocabulary
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Herbal remedies – products developed from plants that exhibit or are
thought to exhibit some medicinal property
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Antimicrobial – a substance that kills or slows the growth of one or
more microorganisms
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Antiseptic – antimicrobial solution, such as alcohol or iodine, that is
used to clean surfaces
6.3 Review Questions
1.
From where do scientists expect that most of the remaining
naturally occurring biotechnology products will come?
2.
How can a technician know if a certain type of bacteria is
sensitive to an antimicrobial substance?
3.
List a few herbal products that claim to have therapeutic value
against depression.
4.
How can molecules be extracted from plant samples for testing
purposes?
6.4 Studying Plant Proteins as Possible Products
Many plants contain proteins of
agricultural or medicinal value.
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.
Extracting Protein Molecules from Cells
Plants are sometimes dense.
Grating a sample increases extraction yields.
Grinding a sample in liquid nitrogen can increase yields.
Removing or Weakening Cell Walls
Enzymes can be used.
Cell walls can be crushed.
Cells can be burst open by “freeze fracture.”
Visualizing Protein Samples
If a gel shows evidence of a protein of
interest, more studies are conducted.
Vocabulary
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Phenotype – the characteristics observed from the expression of genes, or genotype
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Genotype – the genetic makeup of an organism; the particular form of a gene present
for a specific trait
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Genetically modified organism – an organism produced by genetic engineering
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Cellulase – an enzyme that weakens plant cell walls by degrading cellulose
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Pectinase – an enzyme that weakens plant cell walls by degrading pectin
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Protoblast – a cell in which the cell wall has been degraded and is surrounded by only
a membrane
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Macerated – crushed, ground up, or shredded
6.4 Review Questions
1.
Distinguish between phenotype and genotype using
examples.
2.
What does GMO stand for? Explain how Monsanto
Canada, Inc’s Roundup Ready® soybeans are an
example of a GMO.
3.
What is the most challenging part about trying to
isolate plant DNA or plant proteins from cells?
4.
Of what value are plant cell protoplasts?
6.5 Producing Recombinant DNA (rDNA) Protein Products
rDNA was first produced in the mid 1970s.
Vocabulary
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Transfection – genetic engineering, or transformation of mammalian cell lines
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Formulation – the form of a product, as in tablet, powder, injectable liquid, etc.
6.5 Review Questions
1.
What are CHO cells and what are they used for?
2.
How long does it take to develop, test, and market a typical
rDNA protein product?
3.
What does GMO stand for and what does it cover?
4.
Biotechnology products must be formulated before they can be
marketed. Name two formulations for a pharmaceutical product
other than tablet form.
Questions and Comments?