Frequently Asked
Questions - General
What is
Healthcare
Biotechnology?
Healthcare biotechnology
refers to a medicinal or
diagnostic product or a
vaccine that consists
of, or has been produced
in, living organisms and
may be manufactured via
recombinant technology
(recombinant DNA is a
form of DNA that does
not exist naturally. It
is created by combining
DNA sequences that would
not normally occur
together).
This technology has a
tremendous impact on
meeting the needs of
patients and their
families as it not
only encompasses
medicines and
diagnostics that are
manufactured using a
biotechnological
process, but also gene
and cell therapies and
tissue engineered
products.
Today,
the majority of
innovative medicines,
whether manufactured
using biotechnology or
via a chemical synthesis
like a traditional small
molecule medicine, as
well as
many diagnostic products,
are made available by
applying modern
biotechnology in their
development and/or
manufacturing processes.
See below
our Factsheet
"Healthcare
Biotechnology: Using the
human body's own tools
and weapons to fight
diseases" in the
following languages
[top]
What is
different about biotech
treatments?
|
Conventional drugs |
Biotech drugs |
|
Normally made by
mixing chemicals in
a factory |
Far more complex,
mimicking substances
produced by the
human body such as
enzymes, insulin,
and antibodies |
|
They are mostly
small, relatively
simple molecules and
can usually be
shaped into a pill
and swallowed |
Instead
of mixing chemicals,
biotech drugs are
grown in live cells
in a bioreactor and
then purified. The
resulting drugs are
almost always
administered by
injection or infusion |
|
There are around 50
monitoring and
quality tests for a
traditional
(chemical) medicine |
Because
biotechnology drugs
are so complex, the
manufacturing of
biotechnology-based
medicines requires a
high level of
monitoring and
quality testing -
typically, around
250 in-process tests
are conducted for a
biological medicine |
|
Conventional drugs,
based on relatively
simple molecules,
are easy to copy |
The
unique starting
material and the
complex
manufacturing
processes mean that
it is more difficult
to exactly reproduce
a biological
molecule in a copy |
[top]
What are
the facts and figures
for healthcare
biotechnology?
From diagnosis to
treatment and in terms
of medicines
manufactured, healthcare
biotechnology is already
delivering on its
promises
Ø
More than 350 million
patients have to date benefited
from biotech medicines
(including gene
technology) to treat or
prevent heart attacks,
stroke, multiple
sclerosis, breast
cancer, cystic fibrosis, leukemia, hepatitis,
diabetes and other
diseases.
Ø
Biological products currently represent 40% of
the total registered
products*.
Ø An
estimated 50% of all new
medicines originate from
biotechnologies, and the
proportion grows when it
comes to the most
innovative treatments
such as: growth
hormones, recombinant
growth factors,
vaccinations, monoclonal
antibodies for the
treatment of cancers and
inflammatory and
infectious diseases,
cell therapy etc.
Ø
Healthcare biotechnology
continues to grow
annually at an average
rate of 20% -more than
double that of
traditional pharma - and
that it is 7 times
larger than it was 10
years ago.
Ø
The most recent report
from PhRMA** reported
that more than 600
biotech medicines were
being tested to treat
more than 100 diseases.
Among these 600
biotechnology medicines
are:
·
210 medicines to treat
cancer
·
50 medicines to treat
infectious disease
·
44 to treat autoimmune
disorder
·
22 to treat HIV
infection and related
conditions
·
And 22 to treat
cardiovascular diseases
*taking into
account
chemical
medicines
developed
with
biotechnologies
**The
Pharmaceutical
Research and
Manufacturers
of America
What kind of
treatments
can
healthcare
biotech
provide for
the
patients?
Biotechnology aims
to target the causes
of
diseases rather than
just the symptoms.
And that’s why
biotechnology offers
one of the strongest
hopes for patients
to treat diseases.
Biotechnology offers
patients a variety
of new solutions
such as:
-
Unique, targeted and
personalized therapeutic
and diagnostic solutions
for particular diseases
or illnesses
-
An unlimited amount of
potentially safer
products
-
Superior therapeutic
and diagnostic
approaches
-
Higher clinical
effectiveness
because of the
biological basis of
the diseases being
known
[top]
How
are biological
medicines
manufactured?
Biotechnology
medicines and
therapies use
proteins, enzymes,
antibodies and other
substances naturally
produced in the
human body to treat
diseases, including
genetic disorders.
Biotechnology
also uses other
living organisms -
plant and animal
cells, bacteria,
viruses and yeasts –
in the large-scale
production of
medicines for human
use.
Biotechnology
produces information
that is used to
alter and improve
cell behavior. Many
biotech companies
specialize in
finding ways to
deliver and apply
biotechnology
information to cells
to aid in
identifying,
preventing and
treating disease.
Representative
applications include
diagnostic tests
that use
biotechnology
materials to detect
the presence or risk
of disease such as
cancer, genetic
diseases or
pollution of a cell
or material.
There
are
three primary areas
in healthcare in
which biotechnology
is currently being
used: medicines
(also including
advanced therapies
such as cell and
gene therapy),
vaccines and
diagnostics
Biotechnology is
offering new tools
to doctors and
patients to provide
better diagnosis and
more effective but
less intrusive and
uncomfortable
testing for
patients.
A
familiar
example of
biotechnology's
benefits is the new
generation of home
pregnancy tests that
provide more
accurate results
much earlier than
previous
test-generations.
[top]
Many
years can be
spent
in
identifying
the
therapeutic
molecule,
determining
its genetic
sequence and
working out
a process to
make the
treatment
stable,
biologically
active and
reproducible.
As a result,
the biotech
industry
spends more
on research
and
development
(about 20-
25% of
revenue)
compared to
the
mainstream
pharmaceutical
industry
(about 15%
of revenue).
A biotech
treatment
requires
specialized
and complex
manufacturing
techniques
and
distribution
processes,
making the
mass
handling of
therapies
very
difficult.
Since
biotech
drugs are
derived from
natural
sources,
they are
often less
stable than
synthetic
molecules
and
necessitate
special
handling and
distribution.
Most
biotech
treatments
can not be
administered
orally, but
need to be
injected or
infused.
This
requires a
high purity
and
sterility
for biologic
medicines,
adding to
their cost.
One of
the main
benefits of
biotech
treatments
is that they
often target
patients
with
relatively
uncommon
diseases or
those who
constitute a
small subset
of patients
with a
highly
prevalent
condition
such as
asthma.
However, the
development
and
approvals
process
costs the
same as a
more widely
applicable
treatment,
but with a
smaller
patient
basis that
can take
advantage of
the
treatment.
What are
personalized
medicines?
Personalized
medicines
are about
tailoring
medical
treatments
to patients.
For patients
this means
finding the
right
medication
with less
trial and
error and
helping to
deliver
made-to-measure
treatments.
How are
personalized
medicines
and
biotechnology
related?
Personalized
medicines are an
exciting new area
that is becoming
possible because we
can now identify
more accurately the
right treatment for
patient through
analysis of their
genetic data.
New technologies
such as
pharmacogenetics and
proteomics use
biotechnology-based
technologies to give
a better diagnosis
of a disease by
using patients’
genetic information,
and also to match
the right drug, at
the right dose, at
the right time to
the patient. The
evolution of
pharmacogenetics
will increase both
the safety and
efficacy of
treatments by
diminishing the
trial and error for
patients trying to
find the optimal
dose and treatment.
These new
technologies are
contributing to the
development of
personalized
medicines.
[top]
EuropaBio
is a
founding
member of
the EPAA –
the European
Platform for
Alternative
Approaches
to Animal
Testing, and
fully
supports the
principle of
the “3 Rs”
(refine,
reduce,
replace
animals in
testing). We
fully
support to
minimize
animal
suffering in
testing and
promote
biotechnology
as being at
the cutting
edge in
delivering
alternatives
to animal
testing.
EuropaBio
has
successfully
promoted
biotech
companies
researching
and
providing
alternatives
to animal
testing. A
study has
reported
that four
new biotech
testing
methods can
reduce the
need for
animals and
cut
validation
times in
half. These
newly
discovered
assays for
bacterial
contamination
detection
(known as
pyrogens)
have the
potential to
reduce
animal tests
in Europe by
200,000
rabbits each
year. Most
interestingly,
they can
also be used
for new cell
therapies
where no
appropriate
test had
previously
been
available.
For more
in-depth
information
on
EuropaBio’s
position on
animal
testing,
please see
our Position
Paper, which
you can find
here
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