Biological drugs making
The biological drugs have an
edge over their chemical counterparts when it comes to safety, and have
been largely accepted by both the consumers and the medical community
for safer and effective patient treatment
These days, one cannot escape hearing the word,
‘biotechnology’ or ‘biological
drugs’ while watching television, listening to a radio
broadcast or reading a scientific magazine or a newspaper. One often
wonders, “what has biotechnology got to do with the
biological drugs, and why and how are they different from the
drugs we normally have been taken for years since the start of chemical
revolution in early 1900s”?
The answer lies in the biotech revolution that took roots in 1953 with
the discovery of DNA structure by Watson and Crick, followed by the
discovery of restriction enzymes and hybridoma technology two decades
later, coupled with the invention of PCR in 1983. After that, nothing
stopped the biological revolution which grew by leaps and bounds, and
has given us several new and interesting biological drugs in the last
two decades. These drugs not only have made a big difference in our
lives but also offer better treatment options for patients than before.
Let us first address the fundamental question, “What are
biological drugs and how are they different from the normal drugs we
are used to taking”?
Biologicals or ‘protein based drugs’ use different
proteins that occur naturally in any living organism, to diagnose,
prevent and treat diseases and related conditions. Traditionally,
proteins have been isolated from plant and human sources and used for
alleviating diseases, but the advent of recombinant DNA technology has
enabled large-scale production of these futuristic biological drugs to
be developed for human health care.
The major difference between biological drugs and chemical-based normal
prescription drugs is that biological drugs are highly specific and
work with almost ‘pinpoint’ accuracy to treat the
diseased organs or cells that require treatment. This
particular trait also makes them safer, with little side effects, when
compared to chemical-based drugs. These drugs of the future are being
developed through advanced technology called genetic engineering or
recombinant DNA technology.
Safe, effective healthcare is a key concern worldwide. The drug
regulatory agencies across the globe keep safety of drugs as their
primary agenda while evaluating new drug candidates. The biological
drugs have an edge over their chemical counterparts when it comes to
safety, and have been largely accepted by both the consumers and the
medical community for safer and effective patient treatment.
mode of action
Cytokines: These are proteins, peptides or glycoproteins that are
secreted by specific cells of the immune system and carry signals
locally between cells, and thus have an effect on other cells. The list
includes lymphokines, interleukins and chemokines.
Clotting factors: These are proteins that regulate the clotting of
blood and help in maintaining internal homeostasis. These drugs are
used to treat blood clotting disorders like hemophilia.
Vaccines: These are proteins that provide immunity to a particular
disease by stimulating the production of specific antibodies thereby,
preventing or treating the disease.
Monoclonal antibodies: These antibodies are monospecific antibodies and
are so called because they are produced by one type of immune cell that
are all clones of a single parent cell. These antibodies are very
specific to their target such as cancer cells, disease-causing bacteria
and viruses for their destruction by other components of the immune
Bio-therapeutics: Proteins that interact to inhibit or augment the
activity of disease causing enzymes/proteins.
Few of the examples of biological drugs include insulin, G-CSF,
Erythropoietin, GM-CSF and a variety of monoclonal antibodies for
transplant rejection (Muronomab-CD3, Daclizumab, Basiliximab),
cardiovascular disease (Abciximab) and cancer (Rituximab, Trastuzumab
(Herceptin) Gemtuzumab ozogamicin, Alemtuzumab, Cetuximab and
Monoclonal antibodies are by far the most used of all the biological
drugs today. These antibodies have been made in such a manner that they
can bind to a specific target and, thus, can be used to treat
disease-specific cells and tissues in a safe and effective manner with
fewer side effects. One of the initial disadvantages of therapeutic
monoclonal antibodies was that they triggered immune reaction causing
production of HAMA (human anti-mouse antibodies) in human
subjectCellular Subscriber Bases. This was because the
monoclonal antibodies were made with mouse Fab and Fc region. However,
this was overcome by the production of chimeric antibodies wherein the
constant Fc portion was replaced with the human’s while
keeping the hyper variable regions from mouse, thus reducing the immune
reaction. Currently, fully humanized antibodies are also being
developed for certain treatments although they are not required for all
disease or disease related conditions.
Are biologicals really
Although biological drugs present a safe and efficacious form of
treatment, they suffer from a number of disadvantages. The
disadvantages are: (i) higher cost compared to their chemical
counterparts, (ii) batch to batch variability in production, (iii) drug
delivery mechanism (mostly injectable) as they can’t be
orally taken as chemical drugs and (iv) sometimes biological drugs have
rare side effects that can be severe and life-threatening.
What future holds?
In spite of the disadvantages, biologicals present a gr eat promise for
the future of medicine. These are drugs of the future. To the
patient, one of the most important advantages of being treated with
these biological drugs is the improvement in their quality of life.
The biggest concern of patients when it comes to healthcare
is cost. Biological drugs are currently costly, but will and can become
cheaper in future with the improvements in manufacturing capabilities
by enhancing production and eliminating downstream process purification
steps. The recognition of these drugs’ potential benefits has
put them on the fast track for FDA approval. The day is not
far when biologicals would overtake their chemical counterparts in
terms of the number of drugs approved and being in use.
The Indian scenario
The development of biologicals in the western world is on the fast
track. India needs to wake up to this challenge and start investing in
new drug discovery in the area of biologicals. India has been a
successful generic player in the field of small molecule drug
discovery, and is currently focusing on development of biogenerics or
biosimilars versions of the proprietary biological drugs. If India does
not want to miss the biotech bandwagon, we (the industry, academia and
the government) should seriously get together and start the process of
identifying and developing novel bio-therapeutics. This is not only to
put India on the map of new drug discovery but also to develop
cost-effective treatments for our own country.
We at Premas Biotech are trying in a small way to help in this cause.
Premas has invested in and developed a platform technology to discover
novel biological drugs for Alzheimer’s disease and cancer.
This technology is available for exploitation by pharma and biotech
companies to develop novel biologicals.