Lately the United States Food and Drug Administration (better known
as the FDA) has been quite busy reviewing and approving applications
for medications that have been developed by way of biotechnology.
For example, on August 24, 1998 the FDA approved a new drug called
REMICADE (infliximab) manufactured by Centocor for the treatment of
patients with Crohn’s disease, an inflammatory disorder of the
REMICADE is the first of a new class of
agents designed to block the activity of a biologic-response mediator
called tumor necrosis factor alpha (TNF-alpha). REMICADE binds to TNR-
alpha, neutralizes TNF-alpha on the cell membrane and in blood, and
destroys the cells that make TNF-alpha. It thereby reduces both TNF-
alpha and the intestinal
inflammation in patients with Crohn’s disease.
For another example, HERCEPTIN (an antibody directed against a
protein called HER2) that is made by Genentech is close to final
approval by the FDA
to fight breast cancer. Patients whose tumor cells have extra copies
of the HER2 protein do significantly better when HERCEPTIN is added
to standard chemotherapy. Also known as HER2/neu and c-erbB-2, the
HER2 protein is what is termed a cell-surface receptor that transmits
growth signals to the cell nucleus. HERCEPTIN is a humanized
monoclonal antibody that appears to block these signals.
These and other medications have recently joined a long list of drugs
designed and produced by the "biotech" industry, an industry which is
still less than 20 years old.
MedicineNet Medical Dictionary defines
Biotechnology as: "The fusion of biology and technology.
is the application of biological techniques to product research and
development. In particular, biotechnology involves the use by
industry of recombinant DNA, cell fusion, and new bioprocessing
techniques. Biotechnology is expected to become increasingly
important in the 21st century."
Another way to look at it, according to the Encyclopedia Britannica,
is to consider biotechnology as the "the application to industry of
advances made in the techniques and instruments of research in the
The biotech industry grew rapidly in the 1980's after the U.S.
Court ruled that it was possible to patent "a live human-made
The field of biotechnology has grown to include not only the
techniques of genetic engineering but also many other biological
techniques as applied to product research and
development. Now, biotechnology includes facets of cancer research
and treatment, research into cytokines (chemicals that are involved in
inflammation and other body processes), poison control, and infectious
disease therapies, to name but a few applications.
Insulin, human growth hormone and many other molecules close to the
naturally occurring forms (or identical to them) have already emerged
from research in biotechnology. These types of products are
much less likely to be rejected or destroyed by the human immune
system, which would otherwise recognize them as foreign.
Similar biotech techniques are being applied to the area of organ and
cell transplants and are improving the success rates in the field of
The biotech industry has done much more than just develop
medications. The creation of bacteria that improve our ability to
eliminate toxic wastes is another important contribution by
To help you in further reading, many relevant terms are defined in
MedicineNet Medical Dictionary. Just a
few of the terms that
you may come across are:
Antibodies: Specialized proteins produced by white blood cells
that circulate in the blood seeking and attaching to foreign
proteins, microorganisms or toxins in order to neutralize them. They
are part of the immune system.
Monoclonal: Derived from a single cell and cells identical to that
Monoclonal antibodies: Identical antibodies that are made in large
in the laboratory. Doctors and scientists are studying ways of using
to treat leukemia and other diseases.
Receptor: In cell biology, a receptor is a structure on the surface
of a cell or inside a cell that selectively receives and binds a
specific substance. There are, for example, insulin receptors, low-
density lipoprotein (LDL) receptors, etc.
Recombinant DNA molecules: A combination of DNA molecules of
different origin that are joined using recombinant DNA technology.
Recombinant DNA technology: A series of procedures used to join
together (recombine) DNA segments. A recombinant DNA molecule is
constructed (recombined) from segments from two or more different DNA
molecules. Under certain conditions, a recombinant DNA molecule can
enter a cell and replicate there, autonomously (on its own) or after
it has become integrated into a chromosome.
An excellent source of material regarding the
Biotechnology Industry is
The World Wide Web Virtual
The field of biotechnology has become so important that numerous
publications are now devoted to it, among them an offspring of the
eminent British journal Nature, Nature
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