What is Biotechnology

workkinkajouBiotechnology

Dec 5, 2012 (4 years and 6 months ago)

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Chapter 1

What is Biotechnology

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.

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.

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

Defining Biotechnology


Enables production of previously unavailable
materials


Insulin


Proteases


Removes stains from clothing


Antibodies


.: not just a science, but an industry, also

Biotechnology

Workers 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

Biotechnology

Workers 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

Biotechnology

Workers and Workplaces


University and Government Research labs


Usually for “pure research”


Not for profit


Uses same techniques as in industry


Doesn’t 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

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

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

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

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

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

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

Bioengineered Products




A Snowballing Effect
-
began with structure of
DNA


1970’s


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)

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)

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

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”

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


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

Regulations Governing Product
Development


All biotech products heavily regulated


EPA or USDA


Drugs and cosmetics


Chemicals


Crops

See page 18, figure 1.24

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

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