What is Biotechnology

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Chapter 1

• What is Biotechnology

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Defining Biotechnology

• Biotechnology in one form or another has
  flourished since prehistoric times.
• Planting their own crops and breed their own
  animals, they learned to use biotechnology.
• The discovery that fruit juices fermented into
  wine, or that milk could be converted into cheese
  or yogurt, or that beer could be made by
  fermenting solutions of malt and hops began the
  study of biotechnology.
• When the first bakers found that they could make
  a soft, spongy bread rather than a firm, thin
  cracker, they were acting as fledgling
  biotechnologists.
• The first animal breeders, realizing that
  different physical traits could be either
  magnified or lost by mating appropriate pairs of
  animals, engaged in the manipulations of
  biotechnology.

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Defining Biotechnology

• Biotechnology" refers to the use of living
  organisms or their products to modify human
  health and the human environment.
• Not just for manipulating whole organisms
• Using the techniques of gene splicing and
  recombinant DNA technology we can now actually
  combine the genetic elements of two or more
  living cells.
• Functioning lengths of DNA can be taken from one
  organism and placed into the cells of another
  organism.
• We can cause bacterial cells to produce human
  molecules.
• Cows can produce more milk for the same amount of
  feed.
• And we can synthesize therapeutic molecules that
  have never before existed.
• In other words, Biotechnology is the
  study/manipulation of living things or the their
  component molecules, cells, tissues, organs.

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Defining Biotechnology

• Very expansive field- mostly involves work with
  DNA
• rDNA technology
• Cutting/recombining DNA
• Polymerase chain reaction
• Copying short pieces of DNA
• Making large amount of copies
• Cloning
• Identical organisms
• Essentially many practices from over time
• Selective breeding of animals and plants

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Defining Biotechnology

• Enables production of previously unavailable
  materials
• Insulin
• Proteases
• Removes stains from clothing
• Antibodies
• . not just a science, but an industry, also

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BiotechnologyWorkers and Workplaces

• Many settings
• Companies, universities, government agencies
• Industry
• Development/manufacture of products for sale
• Pharmaceutical, agricultural, industrial
  products, industrial. research instruments
• Universities/government labs
• Mostly pure research

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BiotechnologyWorkers and Workplaces

• Biotechnology companies
• Thousands
• Produce wide variety of products
• Goal is produce and sell commercial products
  for-profit
• Profits go to support internal R D
• Different types of biotech companies
• Pharmaceutical products
• Agricultural products
• Industrial products
• Research or production instruments, reagents, or
  data
• Others sell their services
• DNA/protein sequencing

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BiotechnologyWorkers and Workplaces

• University and Government Research labs
• Usually for pure research
• Not for profit
• Uses same techniques as in industry
• Doesnt provide earnings
• Support from grants
• From industry, foundation, or the government
• Data collected
• Shared at scientific meetings
• Scientific journals
• For the public good
• Information usually used to further for-profit
  work in industry

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Biotechnology-Growth in the Biotechnology Industry

• Where are most of the jobs?
• Medical instruments and diagnostic tools
• Drugs
• Industrial/environmental applications
• New agricultural crops
• Growth
• Very dramatic
• Original companies found
• Bay area
• Boston
• Madison
• North Carolina
• Now can be found anywhere

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The Increasing Variety of Biotechnology Products

• Number of products increases every year
• Antibiotics
• Most are natural products
• Significant impact on life
• Reduced death and suffering
• Penicillin form Penicillium sp.
• Modifications of the penicillin molecule
• Different versions
• Used for mutated versions of the bacteria
• Amoxicillin
• Carbenicillin
• Plant extracts
• Many medical/industrial products
• Rubber-helped fuel industrialization
• Resins
• Turpentine
• Maple syrup

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Domains of Biotechnology

• Industrial and Environmental Biotechnology
• Fermented foods and beverages
• Genetically engineered proteins for industry
• DNA identification/fingerprinting of endangered
  species
• Biocatalysts
• Biopolymers
• Biosensors, bioterrorism, and biodefense
• Bioremediation

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Domains of Biotechnology

• Diagnostic Research Biotechnology
• DNA and protein synthesis
• DNA an protein sequencing, genomics, proteonomics
• Genetic testing and screening
• DNA identification and DNA fingerprinting,
  forensics
• Bioinformatics and microarrays
• Polymerase chain reaction
• ELISA, Western Blots, protein identification,
  purification
• Nanotechnology

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Domains of Biotechnology

• Medical/Pharmaceutical Biotechnology
• Medicines from plants, animals, fungi
• Medicines from genetically engineered cells
• Monoclonal and polyclonal antibodies
• Vaccine and gene therapy
• Prosthetics, artificial or engineered organs and
  tissues
• Designer drugs and antibodies

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Domains of Biotechnology

• Agricultural Biotechnology
• Breeding of livestock and plant crops
• Aquaculture and marine biotechnology
• Horticultural products
• Asexual plant propagation and plant tissue
  culture
• Transgenic plants and animals
• Production of plant fibers
• Pharmaceuticals in genetically engineered plant
  crops

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Bioengineered Products

• A Snowballing Effect-began with structure of DNA
• 1970s
• Restriction enzymes
• Cut DNA a very particular places in the sequence
• DNA ligase
• Anneals DNA-pastes the pieces together
• Creates new combinations
• Called recombinant DNA
• Inserted into cells to give new characteristics
• Called bioengineered or Genetically Modified
  Organisms (GMOs)

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Bioengineered Products

• First GMOs
• Human growth hormone Somatostatin
• Human gene into E. coli plasmids
• Human tissue plasminogen activator (t-PA)
• True bioengineered product
• Blood clot dissolving enzyme
• Clears blocked blood vessels after heart attack
  or stoke
• Only produced in very small amounts by the human
  body
• Now produced by engineered CHO cells (pg 12
  figure 1.18)

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How Companies Select Products to Manufacture

• Companies usually specialize in a group of
  similar products
• Bayer Biotech
• Therapeutic drugs
• Monsanto
• Plant products
• Why?
• Similar products produced in similar ways
• Reduces manufacturing costs
• Reduces supply costs

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How Companies Select Products to Manufacture

• R D
• Goal is to market product ASAP
• R D can take years
• Proof of concept needed from the research
  laboratory
• Then move into development phase
• Several things assessed
• Is it feasible to produce a new medicine in
  amounts needed to treat people
• What to do to ensure safety
• How do you prove efficacy (effective)
• Stability
• If the assessment is favorable, then moves to
  clinical development
• First small scale production
• Then large-scale production
• Pharmaceuticals
• Guided by the FDA
• Takes about 10-15 years to go through the
  pipeline

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R D-Product Development Plan

• Product Planning is critical to any organization
• A well-conceived and comprehensive Product
  Development Plan (PDP) can provide a detailed
  assessment of your product and the most effective
  pathway to market or licensure.
• The PDP is
• A "roadmap" for your product's development
• A concise, product-focused strategic document
  laying out the path to market approval or
  licensure
• A detailed analysis of your product status and
  developmental requirements
• Includes four primary aspects of product
  development
• Manufacturing
• Preclinical
• Regulatory Development
• Clinical Development
• An integrated stand-alone document tying all the
  four main areas of product development with
  budgets, tasks and timelines through Phase 1 or
  beyond

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R D-Product Development Plan

• Why Develop a PDP?
• Planning is crucial at every stage of
  development, particularly at the outset
• Provides a concise detailed analysis of your
  product and the roadmap to market
• Clearly states developmental objectives and
  crucial milestones
• Presents a single (or multiple, if desired)
  focused regulatory strategy for presenting your
  product to the FDA
• Presents strategies for dealing with potential
  roadblocks and hurdles in the product development
  process
• Lays out accurate and realistic budgets and
  timelines through clinical development

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Regulations Governing Product Development

• All biotech products heavily regulated
• EPA or USDA
• Drugs and cosmetics
• Chemicals
• Crops
• See page 18, figure 1.24

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Scientific Methodology in a Research Facility

• Goal To ensure unbiased, reproducible data
• Usually occurs in 5 general steps of asking and
  answering scientific questions
• 1. State a testable scientific question/problem
  based on some information or observation
• Usually comes from previous experimental results
  or a new idea
• 2. Develop a testable hypothesis
• A statement that attempts to answer the
  scientific question
• Implies how to test and the kind of data to be
  collected

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Scientific Methodology in a Research Facility

• 3. Plan a valid experiment
• Contains quantitative data, multiple
  replications, a SINGLE manipulated variable, and
  a control
• Control- 2 types
• -Positive control-gives predictable results
• -Negative control- lacks what is being tested so
  as to give expected negative results
• 4. Conduct the outlined experiment and collect
  and organize the data into tables, charts,
  graphs, or graphics
• 5. Formulate a conclusion based on experimental
  data and error analysis
• -conclusion also suggests further
  experimentation and applications of the findings