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Producing Human Products |
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Biotechnology can be used to
produce large amounts of
proteins, hormones and
enzymes that are of benefit
to humans and to produce new
and safer vaccines.
As well as using
genetically modified
bacterial cells, GM yeasts
are often used to produce
the large protein molecules
of some hormones. |
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Insulin for diabetes
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Diabetes is a common and
sometimes fatal disease that
occurs when the supply of
insulin is insufficient for
the body to break down sugar
properly.
The majority of insulin
used by people to manage
diabetes is produced using
biotechnology. Bacterial
cells are genetically
modified to produce large
quantities of human insulin,
which is then purified for
therapeutic use. Millions of
people worldwide now use
Humuline, which is a major
brand name for ‘human’
insulin produced using GM
bacteria.
For many years,
individuals with diabetes
were treated with insulin
derived from the pancreases
of abattoir animals (usually
pigs and cows). Although
animal insulin is similar to
the human form, there are
some differences. This means
that some individuals cannot
tolerate it. There are also
issues regarding the
sustainable use of animals
for this purpose.
Some human proteins that
have been generated in
similar ways to insulin
include human growth
hormone, blood-clotting
factors needed to treat
haemophilia, and
erythropoietin, which is
used to treat anaemia. |
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As well as
using genetically engineered
bacterial cells, engineered
yeast are often used to
produce the large protein
molecules of some hormones.
For many years,
individuals with diabetes
were treated with insulin
derived from the pancreas of
abattoir animals (usually
pigs and cows). Although
animal insulin is similar to
the human form, there are
differences which means some
individuals cannot tolerate
it and there are issues
regarding the sustainable
use of animals for this
purpose. The advent of
biotechnology radically
changed this. By inserting a
copy of the human insulin
gene into a bacterial
vector, it was possible to
produce insulin chemically
identical to the naturally
produced form.
Millions of people
worldwide now use Humulinë,
which is a major brand name
for ‘human‘ insulin produced
using this method |
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Vaccines
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Vaccines are a product of
biotechnology. The process
of vaccination relies on
boosting the body’s immune
response — its natural
defence system. Most
vaccines contain one of the
following:
- low doses of dead
pathogenic
(disease-causing)
microorganisms
- inactivated toxins
from pathogenic bacteria
- weakened live
pathogenic organisms that
are unable to cause the
severe form of the
disease.
The body recognises a
vaccine as a foreign
substance. The cells of the
immune system mount an
immune response to destroy
it, producing specific
antibodies that recognise
the foreign substance. The
antibodies remain in the
body, ready to fight future
infections of the
naturally-occurring form of
the disease.
Read more about the
immune system:
http://health.howstuffworks.com/immune-system.htm
Vaccines have
revolutionised the fight
against infectious diseases.
They are used to control
life-threatening illnesses
such as measles, polio,
tuberculosis, tetanus,
rabies, smallpox, cholera,
typhoid fever, diphtheria,
pertussis (whooping cough),
Japanese encephalitis and
yellow fever.
The practice of
vaccination began in England
in 1796, when Edward Jenner
vaccinated an eight-year-old
boy against smallpox by
using the closely related
cow pox virus. Smallpox is
an acute, contagious, and
sometimes fatal disease
causing fever and raised
skin rashes. In 1980, after
a worldwide vaccination
program, smallpox was
declared completely
eradicated.

A global campaign to
eradicate polio is currently
underway. Polio is a highly
infectious disease that
mainly infects children,
particularly in developing
countries. The polio virus
attacks the nervous system
and can cause total
paralysis in a matter of
hours. Those who survive are
faced with life-long health
problems.
These days, v accines are
researched and developed in
a very different way from
earlier methods. Genetic
modification techniques
allows a gene coding for a
protein of a disease-causing
organism to be isolated and
transferred into bacteria.
The GM bacteria then
produce large quantities of
the protein that can be
purified and used as a
vaccine. This approach has
also been used with GM
yeast, which produce
hepatitis B vaccine. |
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Vaccines in our food?
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Imagine if you went to the
doctor and instead of an
injection, you were handed
an apple to eat.
Researchers have been
looking at ways to produce
edible vaccines, making
vaccination programs as easy
as eating a piece of fruit
or vegetable. They hoped
that such foods could be
grown and administered in
developing countries,
providing cheap sources of
vaccines without needing
costly refrigeration or
needle injections.
However, developers
decided not to pursue this
research, to avoid any
possibility of vaccine-laden
food straying into shops or
markets. If this occurred,
it could be unwittingly
eaten by consumers, with
unpredictable results.
Instead, developers are now
focusing on making vaccines
in edible parts of plants
that are not sold as food.
While edible vaccine
research has been largely
directed at preventing human
diseases, the same
technology could be valuable
for the production of
vaccines to add to animal
feed.
The first ‘prototype’
edible vaccines were
produced in GM potatoes and
tobacco leaves. The plants
were genetically modified to
produce a toxin from the
bacterial Escherichia
coli strain that causes
severe intestinal disease,
which can be fatal in
developing countries. The GM
potatoes and tobacco leaves
were fed to laboratory mice.
Their immune systems mounted
a sufficient response to the
toxin to protect their
bodies from the bacterium in
further experiments.
In similar experiments,
the gene for a non-toxic
part of the cholera toxin
has been inserted in GM
alfalfa plants. Mice fed
with this alfalfa produced
an immune response against
the cholera toxin.
GM tomato and lettuce
plants have also been
produced that contain the
gene encoding the hepatitis
B surface protein. GM rice
and lettuce for use as a
measles vaccine, GM tomatoes
for rabies and HIV vaccines,
and GM tomato and potatoes
for respiratory syncytial
virus vaccine are also under
development. |
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DNA vaccines
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Instead of stimulating the
body’s immune system using a
dead or weakened form of the
pathogen itself, DNA
vaccines use the pathogen’s
genes. One or more genes
from a pathogen are copied
and multiplied using a
common laboratory technique
called polymerase chain
reaction (PCR). The copied
genes are injected into
muscle cells of the organism
to be vaccinated.
A few muscle cells will
take up the genes and make
their protein product. For
viral pathogens, this will
usually be a virus surface
protein. The organism’s
immune system recognises the
gene product as foreign and
remembers it, just as in
conventional vaccination.
Some advantages of DNA
vaccination are:
- Purity: because DNA
vaccines are made
artificially, they are
much purer than if made
directly from pathogens.
- Specificity: the
vaccine contains only one
of the many genes
necessary for pathogen
reproduction. The small
amount of DNA is enough
for the recipient’s immune
system to recognise as
foreign, but not enough to
cause illness.
- Different genes can be
mixed and injected at the
same time, making it
possible to simultaneously
vaccinate against variants
of a pathogen or several
different pathogens.
- Cost and ease of
storage. Unlike
conventional
protein-based vaccines,
DNA vaccines are
inexpensive to produce,
don’t require
refrigeration and can be
stored for a long time.
DNA vaccination is still
an experimental procedure,
as very few trials have
demonstrated an immune
response strong enough to
protect against disease.
Current studies include
avian influenza and West
Nile virus DNA vaccines, and
a DNA vaccination against
multiple sclerosis |
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Biopharming
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Biopharming, also known as
‘molecular pharming', uses
genetically modified (GM)
plants or animals to produce
pharmaceutical proteins and
chemicals such as vaccines,
hormones, blood clotting and
thinning agents, and
industrial enzymes.
Any GM animal or plant
used for pharmaceutical or
chemical production must be
able to produce the desired
compound at high levels,
while not endangering its
own health. It must also be
able to pass this ability to
its offspring. |
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Pharming with animals
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Some animals have been
genetically modified to
produce human proteins in
their milk. These animals,
such as cows, sheep, pigs,
goats, rabbits and mice, act
as living pharmaceutical
‘factories' . The section
of human DNA containing the
genes for the required
protein is injected into the
animal embryo. The embryo is
then placed into the uterus
of a surrogate mother where
it develops to full term.
The adult GM animal's milk
produces the human protein,
which is purified for
therapeutic use for humans.
This technology was first
used in 1987. GM mice
produced tissue plasminogen
activator, a human protein
used to treat blood clots.
Other research has included:
- cows that produce
- human serum albumin,
used to maintain fluid
balance in the blood
- lactoferrin, a
protein from breast milk
that promotes infant
growth
- sheep that produce
- factor VIII and
factor IX, essential for
blood clotting
- natural
anticoagulants used
during heart surgery
- proteins to treat
lung and liver disease
- rabbits that produce
- human lactoferrin
- human interleukin-2,
a protein essential in
the immune response to
infection and may be
useful in fighting some
types of cancer.
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Pharming with plants
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Researchers have discovered
a lot about plant molecular
make-up — such as proteins,
minerals, sugars and fibres
— as well as the genes
responsible for these
components. Plants can be
bred to emphasise certain
traits, and to overproduce
therapeutically-beneficient
compounds .
Plants make relatively
cheap pharmaceutical and
chemical ‘factories'. In the
same way that sugarcane is
harvested and refined to
produce sugar, compounds
produced inside a GM plant
are extracted and processed
after harvesting. Instead of
producing a food or fibre
product, the end result
could be a medicine, a
plastic, or even an additive
used in the manufacture of
paper. For example,
researchers in South Africa
and England are developing
GM tobacco, bananas and
potatoes containing a
vaccine for human papilloma
virus, which causes cervical
cancer.
Corn is by far the most
popular biopharm plant,
followed by soybeans,
tobacco and rice. Around the
world some 400 biopharm
products are reportedly in
the pipeline, and more than
300 open-air field trials
have already been conducted
in locations across the USA. |
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Tobacco, bananas and
sugarcane have several
advantages for biopharming
over other plants:
- tobacco is a non-food
crop, reducing the risk of
someone accidentally
eating a plant containing
pharmaceuticals. In
Australia , it is also
grown in a highly
regulated environment.
- bananas are sterile,
so there is no risk of the
new gene being transferred
to other banana plants
through cross-pollination.
- sugarcane produces
large amounts of plant
material or biomass and
can also be grown
essentially as a sterile
crop.
Commercial production of
biopharmed pharmaceuticals
is still some time away,
although some compounds are
already produced in plants
for laboratory and
diagnostic work. Issues of
commercial production that
need consideration include:
- the large scale of
crops required to produce
compounds in sufficient
quantity
- ensuring that the
plants do not
cross-pollinate,
potentially transferring
modified genes to other
plant species. One way to
prevent this is by
creating sterile male
plants.
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