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D e p t . o f p h a r m a c y
G o n o B i s h w a b i d y a l a y
S a v a r , D h a k a .
B a n g l a d e s h
4 / 1 9 / 2 0 1 4
Ashikur Rahman
Class Roll: 05
Pharmaceutical
Biotechnology on
Modern
technological
platform
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Summary:
In knowledge-based technology areas such as modern biotechnology, an
excellent technological and intellectual environment is crucial for scientific and
economic success. Knowledge and know-how can be translated into profitable
innovations and be further developed by collaborative networks between
research and industry. The technology platform of the BIOTEC is a central tool
for implementing efficient technology transfer.
The allocation of modern devices, technologies, and services, both for research
groups and collaborators, is an important prerequisite for achieving this goal.
Hence, the main purpose of the technology platform is not to generate revenue,
but rather to increase the efficiency of technology transfer and to improve the
utilization of top quality equipment. (1)
Pharmaceutical Biotechnology provides detailed insight into the technologies
that allow development and production of biopharmaceuticals from start to
finish (from pre-clinical studies, to clinic, through to marketing) that could lead
to cures for most major diseases. (2)
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Introduction:
Biotechnology is the use of living systems and organisms to develop or make
useful products, or "any technological application that uses biological systems,
living organisms or derivatives thereof, to make or modify products or
processes for specific use". (3)
Life Science and Biotechnology (LSBT) is a core and platform research and
development area that will lead the international and domestic industries in the
21st century. It involves the most modern forms of biological, biomedical, and
biochemical engineering research that focus on the functional and therapeutic
roles of genes, proteins, tissues, and organs which are the cellular, biochemical,
and molecular bases of life. Recently, the scope of Life Science and
Biotechnology research is being extended into embryonic/adult stem cell
research and animal cloning. The outcomes of these basic
researches can lead to the development of new therapeutic drugs, diagnostic
kits, biomaterials, and biochemical processes for clinical and industrial
applications. (4)
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Biotechnology has applications in four major industrial areas, including health
care (medical), crop production and agriculture, non food (industrial) uses of
crops and other products (e.g. biodegradable plastics, vegetable oil, bio fuels),
and environmental uses.
For example, one application of biotechnology is the directed use of organisms
for the manufacture of organic products (examples include beer and milk
products). Another example is using naturally present bacteria by the mining
industry in bioleaching. Biotechnology is also used to recycle, treat waste,
cleanup sites contaminated by industrial activities (bioremediation), and also to
produce biological weapons.
A series of derived terms have been coined to identify several branches of
biotechnology; for example:
Bioinformatics is an interdisciplinary field which addresses biological
problems using computational techniques, and makes the rapid organization as
well as analysis of biological data possible. The field may also be referred to as
computational biology, and can be defined as, "conceptualizing biology in terms
of molecules and then applying informatics techniques to understand and
organize the information associated with these molecules, on a large scale."
Bioinformatics plays a key role in various areas, such as functional genomics,
structural
genomics, and proteomics, and forms a key component in the biotechnology
and pharmaceutical sector.
Blue biotechnology is a term that has been used to describe the marine and
aquatic applications of biotechnology, but its use is relatively rare.
Green biotechnology is biotechnology applied to agricultural processes. An
example would be the selection and domestication of plants via micro
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propagation. Another example is the designing of transgenic plants to grow
under specific environments in the presence (or absence) of chemicals.
One hope is that green biotechnology might produce more environmentally
friendly solutions than traditional industrial agriculture. An example of this is
the engineering of a plant to express a pesticide, thereby ending the need of
external application of pesticides. An example of this would be Bt corn.
Whether or not green biotechnology products such as this are ultimately more
environmentally friendly is a topic of considerable debate.
Red biotechnology is applied to medical processes. Some examples are the
designing of organisms to produce antibiotics, and the engineering of genetic
cures through genetic manipulation.
White biotechnology also known as industrial biotechnology, is
biotechnology applied to processes. An example is the designing of an
organism to produce a useful chemical. Another example is the using of
enzymes as industrial catalysts to either produce valuable chemicals or destroy
hazardous/polluting chemicals. White biotechnology tends to consume less in
resources than traditional processes used to produce industrial goods. (5)
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How does modern biotechnology influences over
technological platform:
All organisms are made up of cells that are programmed by the same basic
genetic material, called DNA (deoxyribonucleic acid). Each unit of DNA is
made up of a combination of the following nucleotides -- adenine (A), guanine
(G), thymine (T), and cytosine (D) -- as well as a sugar and a phosphate. These
nucleotides pair up into strands that twist together into a spiral structure call a
"double helix." This double helix is DNA. Segments of the DNA tell
individual cells how to produce specific proteins. These segments are genes. It
is the presence or absence of the specific protein that gives an organism a trait
or characteristic. More than 10,000 different genes are found in most plant and
animal species. This total set of genes for an organism is organized into
chromosomes within the cell nucleus. The process by which a multi cellular
organism develops from a single cell through an embryo stage into an adult is
ultimately controlled by the genetic information of the cell, as well as
interaction of genes and gene products with environmental factors.
When cells reproduce, the DNA strands of the double helix separate. Because
nucleotide A always pairs with T and G always pairs with C, each DNA strand
serves as a precise blueprint for a specific protein. Except for mutations or
mistakes in the replication process, a single cell is equipped with the
information to replicate into millions of identical cells. Because all organisms
are made up of the same type of genetic material (nucleotides A, T, G, and C),
biotechnologists use enzymes to cut and remove DNA segments from one
organism and recombine it with DNA in another organism. This is called
recombinant DNA (rDNA) technology, and it is one of the basic tools of
modern biotechnology. (rDNA technology is the laboratory manipulation of
DNA in which DNA, or fragments of DNA from different sources, are cut and
recombined using enzymes. This recombinant DNA is then inserted into a living
organism. rDNA technology is usually used synonymously with genetic
engineering. rDNA technology allows researchers to move genetic information
between unrelated organisms to produce desired products or characteristics or to
eliminate undesirable characteristics.
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Genetic engineering is the technique of removing, modifying or adding genes to
a DNA molecule in order to change the information it contains. By changing
this information, genetic engineering changes the type or amount of proteins an
organism is capable of producing. Genetic engineering is used in the production
of drugs, human gene therapy, and the development of improved plants .For
example, an “insect protection” gene (Bt) has been inserted into several crops -
corn, cotton, and potatoes - to give farmers new tools for integrated pest
management. Bt corn is resistant to European corn borer. This inherent
resistance thus reduces a farmers pesticide use for controlling European corn
borer, and in turn requires less chemicals and potentially provides higher
yielding Agricultural Biotechnology.
Although major genetic improvements have been made in crops, progress in
conventional breeding programs has been slow. In fact, most crops grown in the
US produce less than their full genetic potential. These shortfalls in yield are
due to the inability of crops to tolerate or adapt to environmental stresses, pests,
and diseases. For example, some of the world's highest yields of potatoes are in
Idaho under irrigation, but in 1993 both quality and yield were severely reduced
because of cold, wet weather and widespread frost damage during June. Some
of the world's best bread wheats and malting barleys are produced in the north-
central states, but in 1993 the disease Fusarium caused an estimated $1 billion
in damage.
Scientists have the ability to insert genes that give biological defense against
diseases and insects, thus reducing the need for chemical pesticides, and they
will soon be able to convey genetic traits that enable crops to better withstand
harsh conditions, such as drought). The International Laboratory for Tropical
Agricultural Biotechnology (ILTAB) is developing transformation techniques
and applications for control of diseases caused by plant viruses in tropical plants
such as rice, cassava and tomato. In 1995, ILTAB reported the first transfer
through biotechnology of a resistance gene from a wild species of rice to a
susceptible cultivated rice variety. The transferred gene expressed resistance to
Xanthomonas oryzae, a bacterium which can destroy the crop through disease.
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The resistant gene was transferred into susceptible rice varieties that are
cultivated on more than 24 million hectares around the world .
Benefits can also be seen in the environment, where insect-protected biotech
crops reduce the need for chemical pesticide use. Insect-protected crops allow
for less potential exposure of farmers and groundwater to chemical residues,
while providing farmers with season-long control. Also by reducing the need for
pest control, impacts and resources spent on the land are less, thereby
preserving the topsoil .
Major advances also have been made through conventional breeding and
selection of livestock, but significant gains can still be made by using
biotechnology . Currently, farmers in the U.S spend $17 billion dollars on
animal health. Diseases such as hog cholera and pests such as screwworm have
been eradicated. Uses of biotechnology in animal production include
development of vaccines to protect animals from disease, production of several
calves from one embryo (cloning), increase of animal growth rate, and rapid
disease detection .
Modern biotechnology has offered opportunities to produce more nutritious and
better tasting foods, higher crop yields and plants that are naturally protected
from disease and insects. Modern biotechnology allows for the transfer of only
one or a few desirable genes, thereby permitting scientists to develop crops with
specific beneficial traits and reduce undesirable traits . Traditional
biotechnology such as cross-pollination in corn produces numerous, non-
selective changes. Genetic modifications have produced fruits that can ripen on
the vine for better taste, yet have longer shelf lives through delayed pectin
degradation . Tomatoes and other produce containing increased levels of certain
nutrients, such as vitamin C, vitamin E, and or beta carotene, and help protect
against the risk of chronic diseases, such as some cancers and heart disease.
Similarly introducing genes that increase available iron levels in rice three-fold
is a potential remedy for iron deficiency, a condition that effects more than two
billion people and causes anemia in about half that number (19). Most of the
today's hard cheese products are made with a biotech enzyme called chymosin.
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This is produced by genetically engineered bacteria which is considered more
purer and plentiful than it’s naturally occurring counterpart, rennet, which is
derived from calf stomach tissue.
In 1992, Monsanto Company successfully inserted a gene from a bacterium into
the Russet Burbank potato. This gene increases the starch content of the potato.
Higher starch content reduces oil absorption during frying, thereby lowering the
cost of processing french fries and chips and reducing the fat content in the
finished product. This product is still awaiting final development and approval.
Modern biotechnology offers effective techniques to address food safety
concerns. Biotechnical methods may be used to decrease the time necessary to
detect foodborne pathogens, toxins, and chemical contaminants, as well as to
increase detection sensitivity. Enzymes, antibodies, and microorganisms
produced using rDNA techniques are being used to monitor food production
and processing systems for quality control .
Biotechnology can compress the time frame required to translate fundamental
discoveries into applications. This is done by controlling which genes are
altered in an organized fashion. For example, a known gene sequence from a
corn plant can be altered to improve yield, increase drought tolerance, and
produce insect resistance (Bt) in one generation. Conventional breeding
techniques would take several years. Conventional breeding techniques would
require that a field of corn is grown and each trait is selected from individual
stalks of corn. The ears of corn from selected stalks with each desired trait (e.g,
drought tolerance and yield performance) would then be grown and combined
(cross-pollinated). Their offspring (hybrid) would be further selected for the
desired result (a high performing corn with drought tolerance). With improved
technology and knowledge about agricultural organisms, processes, and
ecosystems, opportunities will emerge to produce new and improved
agricultural products in an environmentally sound manner.
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In summary, modern biotechnology offers opportunities to improve product
quality, nutritional content, and economic benefits. The genetic makeup of
plants and animals can be modified by either insertion of new useful genes or
removal of unwanted ones. Biotechnology is changing the way plants and
animals are grown, boosting their value to growers, processors, and consumers .
Industrial Biotechnology
Industrial biotechnology applies the techniques of modern molecular biology to
improve the efficiency and reduce the environmental impacts of industrial
processes like textile, paper and pulp, and chemical manufacturing. For
example, industrial biotechnology companies develop biocatalysts, such as
enzymes, to synthesize chemicals. Enzymes are proteins produced by all
organisms. Using biotechnology, the desired enzyme can be manufactured in
commercial quantities.
Commodity chemicals (e.g., polymer-grade acrylamide) and specialty chemicals
can be produced using biotech applications. Traditional chemical synthesis
involves large amounts of energy and often-undesirable products, such as HCl.
Using biocatalysts, the same chemicals can be produced more economically and
more environmentally friendly. An example would be the substitution of
protease in detergents for other cleaning compounds. Detergent proteases,
which remove protein impurities, are essential components of modern
detergents. They are used to break down protein, starch, and fatty acids present
on items being washed. Protease production results in a biomass that in turn
yields a useful byproduct- an organic fertilizer. Biotechnology is also used in
the textile industry for the finishing of fabrics and garments. Biotechnology also
produces biotech-derived cotton that is warmer, stronger, has improved dye
uptake and retention, enhanced absorbency, and wrinkle- and shrink-resistance.
Some agricultural crops, such as corn, can be used in place of petroleum to
produce chemicals. The crop’s sugar can be fermented to acid, which can be
then used as an intermediate to produce other chemical feedstocks for various
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products. It has been projected that 30% of the world’s chemical and fuel needs
could be supplied by such renewable resources in the first half of the next
century. It has been demonstrated, at test scale, that biopulping reduces the
electrical energy required for wood pulping process by 30% .
Environmental Biotechnology
Environmental biotechnology is the used in waste treatment and pollution
prevention. Environmental biotechnology can more efficiently clean up many
wastes than conventional methods and greatly reduce our dependence on
methods for land-based disposal.
Every organism ingests nutrients to live and produces by-products as a result.
Different organisms need different types of nutrients. Some bacteria thrive on
the chemical components of waste products. Environmental engineers use
bioremediation, the broadest application of environmental biotechnology, in two
basic ways. They introduce nutrients to stimulate the activity of bacteria already
present in the soil at a waste site, or add new bacteria to the soil. The bacteria
digest the waste at the site and turn it into harmless byproducts. After the
bacteria consume the waste materials, they die off or return to their normal
population levels in the environment.
Bioremediation, is an area of increasing interest. Through application of
biotechnical methods, enzyme bioreactors are being developed that will pretreat
some industrial waste and food waste components and allow their removal
through the sewage system rather than through solid waste disposal
mechanisms. Waste can also be converted to biofuel to run generators.
Microbes can be induced to produce enzymes needed to convert plant and
vegetable materials into building blocks for biodegradable plastics .
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In some cases, the byproducts of the pollution-fighting microorganisms are
themselves useful. For example, methane can be derived from a form of bacteria
that degrades sulfur liquor, a waste product of paper manufacturing. This
methane can then be used as a fuel or in other industrial processes.
Human Applications
Biotechnical methods are now used to produce many proteins for
pharmaceutical and other specialized purposes. A harmless strain of Escherichia
coli bacteria, given a copy of the gene for human insulin, can make insulin. As
these genetically modified (GM) bacterial cells age, they produce human
insulin, which can be purified and used to treat diabetes in humans.
Microorganisms can also be modified to produce digestive enzymes. In the
future, these microorganisms could be colonized in the intestinal tract of
persons with digestive enzyme insufficiencies. Products of modern
biotechnology include artificial blood vessels from collagen tubes coated with a
layer of the anticoagulant heparin.
Gene therapy – altering DNA within cells in an organism to treat or cure a
disease – is one of the most promising areas of biotechnology research. New
genetic therapies are being developed to treat diseases such as cystic fibrosis,
AIDS and cancer.
DNA fingerprinting is the process of cross matching two strands of DNA. In
criminal investigations, DNA from samples of hair, bodily fluids or skin at a
crime scene are compared with those obtained from the suspects. In practice, it
has become one of the most powerful and widely known applications of
biotechnology today. Another process, polymerase chain reaction (PCR), is also
being used to more quickly and accurately identify the presence of infections
such as AIDS, Lyme disease and Chlamydia.
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Paternity determination is possible because a child’s DNA pattern is inherited,
half from the mother and half from the father. To establish paternity, DNA
fingerprints of the mother, child and the alleged father are compared. The
matching sequences of the mother and the child are eliminated from the child’s
DNA fingerprint; what remains comes from the biological father.
These segments are then compared for a match with the DNA fingerprint of the
alleged father.
DNA testing is also used on human fossils to determine how closely related
fossil samples are from different geographic locations and geologic areas. The
results shed light on the history of human evolution and the manner in which
human ancestors settled different parts of the world .
Biotechnology for the 21st century
Experts in United States anticipate the world’s population in 2050 to be
approximately 8.7 billion persons. The world’s population is growing, but its
surface area is not. Compounding the effects of population growth is the fact
that most of the earth’s ideal farming land is already being utilized. To avoid
damaging environmentally sensitive areas, such as rain forests, we need to
increase crop yields for land currently in use. By increasing crop yields, through
the use of biotechnology the constant need to clear more land for growing food
is reduced.
Countries in Asia, Africa, and elsewhere are grappling with how to continue
feeding a growing population. They are also trying to benefit more from their
existing resources. Biotechnology holds the key to increasing the yield of staple
crops by allowing farmers to reap bigger harvests from currently cultivated
land, while preserving the land’s ability to support continued farming.
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Malnutrition in underdeveloped countries is also being combated with
biotechnology. The Rockefeller Foundation is sponsoring research on “golden
rice”, a crop designed to improve nutrition in the developing world. Rice
breeders are using biotechnology to build Vitamin A into the rice. Vitamin A
deficiency is a common problem in poor countries. A second phase of the
project will increase the iron content in rice to combat anaemia, which is
widespread problem among women and children in underdeveloped countries.
Golden rice, expected to be for sale in Asia in less than five years, will offer
dramatic improvements in nutrition and health for millions of people, with little
additional costs to consumers.
Similar initiatives using genetic manipulation are aimed at making crops more
productive by reducing their dependence on pesticides, fertilizers and irrigation,
or by increasing their resistance to plant diseases.
Increased crop yield, greater flexibility in growing environments, less use of
chemical pesticides and improved nutritional content make agricultural
biotechnology, quite literally, the future of the world’s food supply. (6)
Modern biotechnology in medicine and health care
Modern biotechnology is applied in medicine and health care in therapeutics,
mainly for the discovery, development and production of novel drugs
(biopharmaceuticals, but also small molecule drugs), in preventives for the
development of recombinant vaccines, and in diagnostics, for protein- and
nucleic acids based tests (i.e. mainly immunoassays and genetic tests).
Modern biotechnology has a direct impact on the pharmaceutical sector which
in 2002 created EUR 58 billion of added value or about 4% of the total value
added of the manufacturing sector. In 2003, the pharmaceutical industry
comprised 4111 companies in total, with 75% of these located in six EU
countries (Germany, France, Spain, Italy, UK, and Poland). The 2006 EU
Industrial R&D Investment Scoreboard demonstrates a similar geographic
concentration: the majority of the total 64 pharmaceutical companies included
in the top 1000 EU companies, ranked by R&D investment, were located in
Germany (11), the UK (22) and France (9). According to Eurostat, these
countries are also the largest producers of pharmaceuticals in terms of value-
added. The production value of the EU pharmaceutical industry has grown
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steadily since 1993, at a higher growth rate than the average of the chemicals
sector, and its trade surplus in 2004 was more than EUR 32 billion, having
increased almost five times since 1990 (USA, Switzerland and Japan being the
top three trading partners).
Biopharmaceuticals
Biomedical research has increased our understanding of molecular mechanisms
of the human body, revealing many proteins and peptides produced by the
human body in small quantities but with important functions, which makes them
interesting for therapeutic applications. Examples are growth factors such as
erythropoietin, stimulating red blood cell production, the human growth
hormone, or immune system stimulating interferons. Modern biotechnology, in
particular recombinant DNA technology, made it possible to produce these
substances in larger quantities using microorganisms or cell cultures as “cell
factories”, facilitating their therapeutic use. These products are subsumed under
the term “biopharmaceuticals”. The first biopharmaceutical to reach the market
was recombinant human insulin in 1982. Since then about 142
biopharmaceutical products have been launched worldwide .The main product
classes of marketed biopharmaceutical products are recombinant hormones such
as human insulin, monoclonal antibodies used to treat e.g. cancer but also used
for diagnostic purposes, and recombinant interferons and interleukins.
Economic significance of biopharmaceuticals
Over the last ten years (1996-2005) in the EU, an average of six new
biopharmaceutical products have been launched per year, accounting for about
9% of pharmaceuticals launched in this period (Overall, in 2005, about 85
biopharmaceutical products were available in the The combined pharmaceutical
market in 2005 of the USA, the EU and Japan was about EUR 372 billion
(about 80% of the worldwide market), the EU having a share of 33%.
Biopharmaceuticals in the USA, EU and Japan represented a market of EUR
38.5 billion in 2005, about 10% of the corresponding pharmaceutical market.
The EU has a market share of 30%, similar to the market share for
pharmaceuticals.
The biopharmaceutical market in the EU seems to be more dynamic than the
pharmaceutical market, with average annual growth rates (23%) twice as high
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as for pharmaceuticals (11%). Accordingly, overall, the shares of
biopharmaceuticals in the turnover of pharmaceuticals are increasing, indicating
the growing importance of biopharmaceuticals from an economic perspective).
The average turn-over per marketed biopharmaceutical in the EU has tripled
over the last 10 years and, in 2005, reached a value of EUR 133 million per
year.
Recombinant human insulin
Recombinant human insulin was the first biopharmaceutical product to reach
the market, launched in 1982. Since then, it has largely replaced animal insulin;
today only 30% of the worldwide available insulin is isolated from the porcine
or bovine pancreas of slaughtered animals. At least 15 recombinant human
insulin products are currently on the market, representing about 15% of the
biopharmaceutical market by value. In developed countries animal-based insulin
is hardly available any more.
Insulin is primarily targeted at Type 1 diabetes patients, mainly children and
adolescents (about 5-10% of all diabetes patients) who have lost their ability to
produce insulin and need regular injections of insulin. About 30% of Type 2
diabetes patients require additional insulin to regulate their blood glucose levels.
The underlying cause of Type 2 diabetes is an acquired loss
of sensitivity to the hormone insulin, which affects adults usually over the age
of 40 and is linked to diet and body weight. In 2003, there were about 194
million diabetes patients worldwide; this figure is expected to increase to more
than 330 million by 2025 due to an increase of obesity worldwide.
Complications from diabetes, such as stroke, renal failure, blindness, coronary
artery and peripheral vascular disease, often reduce quality of life and life
expectancy and entail considerable health care costs.
Although recombinant human insulin does not appear to have significant
therapeutic differences compared to animal insulin, clinical adoption of
recombinant insulin is high: about 95% of Type 1 diabetes patients in the EU
use recombinant insulin. Recombinant human insulin seems to be more
expensive than animal insulin in most countries where both are available, e.g. in
European countries (including non-EU countries) the average price of
recombinant human insulin was twice as high as for animal insulin. One
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explanation for the widespread adoption could be the potentially improved
safety of recombinant insulin regarding the risk of immune reaction and
contamination of animal insulin. It is also important to realise that, according to
a study carried out in the USA, the actual cost of insulin, including delivery,
amounts to only 7.6% of diabetes-related health care expenditures.
Recombinant human insulin is the starting point for the development of human
insulin analogues, which reached the market several years ago. The analogues
are developed by using genetic engineering to produce fast acting and slow
acting human insulin. They are designed to improve the control of insulin
requirements over the day, with obvious advantages for the patients. However,
the generally higher prices may reduce their cost-effectiveness, especially in the
case of diabetes type 2 patients.
Recombinant human insulin and insulin analogues are effective in the treatment
of diabetes; however, for these products there is currently limited experimental
evidence showing additional efficacy compared with conventional animal
insulin. Hence, the contribution of biotechnology-derived insulin products to
reducing the burden of diabetes per se compared to animal insulin may need to
be considered marginal. However, insulin analogues may improve the quality of
life of diabetes patients, which could be seen as the major contribution of
recombinant insulin. Judging such qualitative improvements would require
more specific cost- utility analyses and more fundamental ethical decisions.
Interferon-beta for multiple sclerosis
Until 1993, when interferon-beta reached the market, multiple sclerosis (MS)
was treated with corticoids to accelerate recovery from relapses. Corticoids do
not cure MS, and neither do any of the treatments currently available. Also,
interferon-beta belongs to the group of disease modifying drugs: it does not cure
MS, but it may slow down the development of some disabling effects and
decrease the number of relapses. As such, it has developed into the first line
treatment for MS. Currently, four interferon-beta products are available,
representing about 8% of the biopharmaceutical market by value.
Multiple sclerosis (MS) is an autoimmune disease that affects the central
nervous system. Its onset occurs primarily in young adults and it affects women
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more often than men. The exact cause of the disease is unknown, but a genetic
predisposition is suspected. The disorder can manifest in a remitting or
progressive development, and it is characterised by lesions that occur
throughout the brain and spinal cord, which have severe consequences such as
loss of memory or loss of balance and muscle coordination; other symptoms
include slurred speech, tremors, and stiffness or bladder problems. Estimates of
the prevalence of MS in the EU differ between about 2,57,000 in Western
Europe to over 5,63,000 cases in the EU. Given the number of people who
suffer from MS and the fact that it primarily affects young adults, the individual
consequences of this disease are severe and the economic and social costs are
substantial. This is also reflected in the high share of “indirect” costs – i.e. of
costs that occur outside the health care system, like productivity losses, costs for
informal health care or estimates of intangible costs – that usually make up
more than half of total costs.
Regarding cost-effectiveness, no conclusive studies have been identified. The
use of interferon- beta for the treatment of MS is not without controversy. In
2002, the UK’s National Institute for Health and Clinical Excellence (NICE)
issued a guidance not recommending interferon-beta or the current alternative
treatment glatiramer acetate (available since 2000 in some EU Member States)
for the treatment of MS based on clinical performance and cost-effectiveness
considerations. More recent evaluations show modest benefits of interferon-beta
for the progression of MS in the short to medium term. (7)
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Conclusion: Finally we can come to an end by saying that- most of the
educated people regardless of gender are unaware of the importance of
biotechnology in any aspects of our society, even though it is crystal clear that
its technological value has foreseen for a long time to motivate the upcoming
generations. It is certain that human existence and survival on the coming days
rest on the development and rapidly advancement of biotechnology.
Because of the advancement of thorough researched and development, the
importance of biotechnology has come to existence. It is a field in biology that
is extensively used in engineering, medicine, science and technology,
agriculture and other valuable form of applications. Biotechnology can be a
great solution to mankind struggles. So, what does it’s all about? Briefly, it is
merely an applied principles of chemistry, physics and engineering comprise
into biological structure.
Application in modern era includes the field of genetic engineering. It is the
usage of this technology to culture cells and tissues for the modification living
organism for human purposes. By this, the importance of biotechnology in
agriculture increases the crop production which makes it double or even higher
than normal harvest. It has the ability to give biological protection from disease
and pests, so a minor necessity for chemical insecticides. Biotechnology is
capable of conveying genetic qualities of the crops that can withstand the
changing climate condition, obtain an increase of nutritional qualities. This will
provide the farmers a healthy lifestyle due to the less exposure of chemical
residues and eventually give a higher profit.
Benefits of biotechnology can also be experienced in the medical institution. Its
technological application includes pharmaceutical products and medicines, and
human therapy. It helps produced large quantity of protein for nutritional
supplements and insulin for diabetic patient treatment. The gene therapy, in
which is the most successful result of biotechnology research use to cure aids
and cancer.
Application on biotechnology can be seen in industrial plant and factories. They
are used to give an improved effectiveness and competence in production
process while reducing the impact to the environmental issues. Waste products
can be treated and recycled as a help to preserve natural resources.
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It is beyond expectation on what the biotechnology has accomplished and
reached in just a matter of time. Humanity has just start to comprehend and
recognized the endless opportunities it has open. As technology assures to
provide solution to every frightening problem we face every now and then, so is
mankind is expecting a more develop biotechnology in the future. A technology
that is more reliable and firm. This is the importance of biotechnology;
revolution of the future technology. (8)
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Reference:
1) Dresden Biotechnology Centre http://www.biotec.tu-dresden.de/technology-platform/
2) De Montfort University http://www.dmu.ac.uk/study/courses/postgraduate-
courses/pharmaceutical-biotechnology.aspx
3) Wikipedia
https://www.google.com.bd/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&uact=8&
ved=0CCYQFjAA&url=http%3A%2F%2Fen.wikipedia.org%2Fwiki%2FBiotechnology&ei=Op5
QU89i0puJB5H-
gIAH&usg=AFQjCNGplF2VLcYqkSmvXq3Wsxbd5zYvCg&sig2=dQMG2jZUQZPqwqs-
whiGNQbiotechnology.aspx
4) yonsei school of Life science & Biotechnology
https://www.google.com.bd/url?sa=t&rct=j&q=&esrc=s&source=web&cd=8&cad=rja&uact=8&
ved=0CGIQFjAH&url=http%3A%2F%2Fuic.yonsei.ac.kr%2Fimages%2FUD_Life_Science_and
_Biotechnology.pdf&ei=CJxQU7H2NomDiQe5soCwDA&usg=AFQjCNH5eZPVNrV2jTgfaEEL
iZxekAGrbw&sig2=WzalBIin6n_CkFPrHGXqPw
5) Yale Bioinformatics
http://www.primate.or.kr/bioinformatics/Course/Yale/intro.pdf
6) The North Carolina Cooperative Extension Service
North Carolina State University
http://www.ces.ncsu.edu/depts/foodsci/ext/pubs/bioapp.html
7) Consequences, Opportunities and Challenges of Modern Biotechnology for Europe By- Eleni
Zika, Ilias Papatryfon, Oliver Wolf, Manuel Gómez-Barbero, Alexander J. Stein and Anne-Katrin
Bock
http://ebookbrowsee.net/consequences-opportunities-and-challenges-of-modern-biotechnology-
for-europe-pdf-d631986284
(8)Importanceoftech.com
http://importanceoftech.com/importance-of-biotechnology

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Pharmaceutical Biotechnology on Modern Technological Platform

  • 1. D e p t . o f p h a r m a c y G o n o B i s h w a b i d y a l a y S a v a r , D h a k a . B a n g l a d e s h 4 / 1 9 / 2 0 1 4 Ashikur Rahman Class Roll: 05 Pharmaceutical Biotechnology on Modern technological platform
  • 2. 2 | P a g e Summary: In knowledge-based technology areas such as modern biotechnology, an excellent technological and intellectual environment is crucial for scientific and economic success. Knowledge and know-how can be translated into profitable innovations and be further developed by collaborative networks between research and industry. The technology platform of the BIOTEC is a central tool for implementing efficient technology transfer. The allocation of modern devices, technologies, and services, both for research groups and collaborators, is an important prerequisite for achieving this goal. Hence, the main purpose of the technology platform is not to generate revenue, but rather to increase the efficiency of technology transfer and to improve the utilization of top quality equipment. (1) Pharmaceutical Biotechnology provides detailed insight into the technologies that allow development and production of biopharmaceuticals from start to finish (from pre-clinical studies, to clinic, through to marketing) that could lead to cures for most major diseases. (2)
  • 3. 3 | P a g e Introduction: Biotechnology is the use of living systems and organisms to develop or make useful products, or "any technological application that uses biological systems, living organisms or derivatives thereof, to make or modify products or processes for specific use". (3) Life Science and Biotechnology (LSBT) is a core and platform research and development area that will lead the international and domestic industries in the 21st century. It involves the most modern forms of biological, biomedical, and biochemical engineering research that focus on the functional and therapeutic roles of genes, proteins, tissues, and organs which are the cellular, biochemical, and molecular bases of life. Recently, the scope of Life Science and Biotechnology research is being extended into embryonic/adult stem cell research and animal cloning. The outcomes of these basic researches can lead to the development of new therapeutic drugs, diagnostic kits, biomaterials, and biochemical processes for clinical and industrial applications. (4)
  • 4. 4 | P a g e Biotechnology has applications in four major industrial areas, including health care (medical), crop production and agriculture, non food (industrial) uses of crops and other products (e.g. biodegradable plastics, vegetable oil, bio fuels), and environmental uses. For example, one application of biotechnology is the directed use of organisms for the manufacture of organic products (examples include beer and milk products). Another example is using naturally present bacteria by the mining industry in bioleaching. Biotechnology is also used to recycle, treat waste, cleanup sites contaminated by industrial activities (bioremediation), and also to produce biological weapons. A series of derived terms have been coined to identify several branches of biotechnology; for example: Bioinformatics is an interdisciplinary field which addresses biological problems using computational techniques, and makes the rapid organization as well as analysis of biological data possible. The field may also be referred to as computational biology, and can be defined as, "conceptualizing biology in terms of molecules and then applying informatics techniques to understand and organize the information associated with these molecules, on a large scale." Bioinformatics plays a key role in various areas, such as functional genomics, structural genomics, and proteomics, and forms a key component in the biotechnology and pharmaceutical sector. Blue biotechnology is a term that has been used to describe the marine and aquatic applications of biotechnology, but its use is relatively rare. Green biotechnology is biotechnology applied to agricultural processes. An example would be the selection and domestication of plants via micro
  • 5. 5 | P a g e propagation. Another example is the designing of transgenic plants to grow under specific environments in the presence (or absence) of chemicals. One hope is that green biotechnology might produce more environmentally friendly solutions than traditional industrial agriculture. An example of this is the engineering of a plant to express a pesticide, thereby ending the need of external application of pesticides. An example of this would be Bt corn. Whether or not green biotechnology products such as this are ultimately more environmentally friendly is a topic of considerable debate. Red biotechnology is applied to medical processes. Some examples are the designing of organisms to produce antibiotics, and the engineering of genetic cures through genetic manipulation. White biotechnology also known as industrial biotechnology, is biotechnology applied to processes. An example is the designing of an organism to produce a useful chemical. Another example is the using of enzymes as industrial catalysts to either produce valuable chemicals or destroy hazardous/polluting chemicals. White biotechnology tends to consume less in resources than traditional processes used to produce industrial goods. (5)
  • 6. 6 | P a g e How does modern biotechnology influences over technological platform: All organisms are made up of cells that are programmed by the same basic genetic material, called DNA (deoxyribonucleic acid). Each unit of DNA is made up of a combination of the following nucleotides -- adenine (A), guanine (G), thymine (T), and cytosine (D) -- as well as a sugar and a phosphate. These nucleotides pair up into strands that twist together into a spiral structure call a "double helix." This double helix is DNA. Segments of the DNA tell individual cells how to produce specific proteins. These segments are genes. It is the presence or absence of the specific protein that gives an organism a trait or characteristic. More than 10,000 different genes are found in most plant and animal species. This total set of genes for an organism is organized into chromosomes within the cell nucleus. The process by which a multi cellular organism develops from a single cell through an embryo stage into an adult is ultimately controlled by the genetic information of the cell, as well as interaction of genes and gene products with environmental factors. When cells reproduce, the DNA strands of the double helix separate. Because nucleotide A always pairs with T and G always pairs with C, each DNA strand serves as a precise blueprint for a specific protein. Except for mutations or mistakes in the replication process, a single cell is equipped with the information to replicate into millions of identical cells. Because all organisms are made up of the same type of genetic material (nucleotides A, T, G, and C), biotechnologists use enzymes to cut and remove DNA segments from one organism and recombine it with DNA in another organism. This is called recombinant DNA (rDNA) technology, and it is one of the basic tools of modern biotechnology. (rDNA technology is the laboratory manipulation of DNA in which DNA, or fragments of DNA from different sources, are cut and recombined using enzymes. This recombinant DNA is then inserted into a living organism. rDNA technology is usually used synonymously with genetic engineering. rDNA technology allows researchers to move genetic information between unrelated organisms to produce desired products or characteristics or to eliminate undesirable characteristics.
  • 7. 7 | P a g e Genetic engineering is the technique of removing, modifying or adding genes to a DNA molecule in order to change the information it contains. By changing this information, genetic engineering changes the type or amount of proteins an organism is capable of producing. Genetic engineering is used in the production of drugs, human gene therapy, and the development of improved plants .For example, an “insect protection” gene (Bt) has been inserted into several crops - corn, cotton, and potatoes - to give farmers new tools for integrated pest management. Bt corn is resistant to European corn borer. This inherent resistance thus reduces a farmers pesticide use for controlling European corn borer, and in turn requires less chemicals and potentially provides higher yielding Agricultural Biotechnology. Although major genetic improvements have been made in crops, progress in conventional breeding programs has been slow. In fact, most crops grown in the US produce less than their full genetic potential. These shortfalls in yield are due to the inability of crops to tolerate or adapt to environmental stresses, pests, and diseases. For example, some of the world's highest yields of potatoes are in Idaho under irrigation, but in 1993 both quality and yield were severely reduced because of cold, wet weather and widespread frost damage during June. Some of the world's best bread wheats and malting barleys are produced in the north- central states, but in 1993 the disease Fusarium caused an estimated $1 billion in damage. Scientists have the ability to insert genes that give biological defense against diseases and insects, thus reducing the need for chemical pesticides, and they will soon be able to convey genetic traits that enable crops to better withstand harsh conditions, such as drought). The International Laboratory for Tropical Agricultural Biotechnology (ILTAB) is developing transformation techniques and applications for control of diseases caused by plant viruses in tropical plants such as rice, cassava and tomato. In 1995, ILTAB reported the first transfer through biotechnology of a resistance gene from a wild species of rice to a susceptible cultivated rice variety. The transferred gene expressed resistance to Xanthomonas oryzae, a bacterium which can destroy the crop through disease.
  • 8. 8 | P a g e The resistant gene was transferred into susceptible rice varieties that are cultivated on more than 24 million hectares around the world . Benefits can also be seen in the environment, where insect-protected biotech crops reduce the need for chemical pesticide use. Insect-protected crops allow for less potential exposure of farmers and groundwater to chemical residues, while providing farmers with season-long control. Also by reducing the need for pest control, impacts and resources spent on the land are less, thereby preserving the topsoil . Major advances also have been made through conventional breeding and selection of livestock, but significant gains can still be made by using biotechnology . Currently, farmers in the U.S spend $17 billion dollars on animal health. Diseases such as hog cholera and pests such as screwworm have been eradicated. Uses of biotechnology in animal production include development of vaccines to protect animals from disease, production of several calves from one embryo (cloning), increase of animal growth rate, and rapid disease detection . Modern biotechnology has offered opportunities to produce more nutritious and better tasting foods, higher crop yields and plants that are naturally protected from disease and insects. Modern biotechnology allows for the transfer of only one or a few desirable genes, thereby permitting scientists to develop crops with specific beneficial traits and reduce undesirable traits . Traditional biotechnology such as cross-pollination in corn produces numerous, non- selective changes. Genetic modifications have produced fruits that can ripen on the vine for better taste, yet have longer shelf lives through delayed pectin degradation . Tomatoes and other produce containing increased levels of certain nutrients, such as vitamin C, vitamin E, and or beta carotene, and help protect against the risk of chronic diseases, such as some cancers and heart disease. Similarly introducing genes that increase available iron levels in rice three-fold is a potential remedy for iron deficiency, a condition that effects more than two billion people and causes anemia in about half that number (19). Most of the today's hard cheese products are made with a biotech enzyme called chymosin.
  • 9. 9 | P a g e This is produced by genetically engineered bacteria which is considered more purer and plentiful than it’s naturally occurring counterpart, rennet, which is derived from calf stomach tissue. In 1992, Monsanto Company successfully inserted a gene from a bacterium into the Russet Burbank potato. This gene increases the starch content of the potato. Higher starch content reduces oil absorption during frying, thereby lowering the cost of processing french fries and chips and reducing the fat content in the finished product. This product is still awaiting final development and approval. Modern biotechnology offers effective techniques to address food safety concerns. Biotechnical methods may be used to decrease the time necessary to detect foodborne pathogens, toxins, and chemical contaminants, as well as to increase detection sensitivity. Enzymes, antibodies, and microorganisms produced using rDNA techniques are being used to monitor food production and processing systems for quality control . Biotechnology can compress the time frame required to translate fundamental discoveries into applications. This is done by controlling which genes are altered in an organized fashion. For example, a known gene sequence from a corn plant can be altered to improve yield, increase drought tolerance, and produce insect resistance (Bt) in one generation. Conventional breeding techniques would take several years. Conventional breeding techniques would require that a field of corn is grown and each trait is selected from individual stalks of corn. The ears of corn from selected stalks with each desired trait (e.g, drought tolerance and yield performance) would then be grown and combined (cross-pollinated). Their offspring (hybrid) would be further selected for the desired result (a high performing corn with drought tolerance). With improved technology and knowledge about agricultural organisms, processes, and ecosystems, opportunities will emerge to produce new and improved agricultural products in an environmentally sound manner.
  • 10. 10 | P a g e In summary, modern biotechnology offers opportunities to improve product quality, nutritional content, and economic benefits. The genetic makeup of plants and animals can be modified by either insertion of new useful genes or removal of unwanted ones. Biotechnology is changing the way plants and animals are grown, boosting their value to growers, processors, and consumers . Industrial Biotechnology Industrial biotechnology applies the techniques of modern molecular biology to improve the efficiency and reduce the environmental impacts of industrial processes like textile, paper and pulp, and chemical manufacturing. For example, industrial biotechnology companies develop biocatalysts, such as enzymes, to synthesize chemicals. Enzymes are proteins produced by all organisms. Using biotechnology, the desired enzyme can be manufactured in commercial quantities. Commodity chemicals (e.g., polymer-grade acrylamide) and specialty chemicals can be produced using biotech applications. Traditional chemical synthesis involves large amounts of energy and often-undesirable products, such as HCl. Using biocatalysts, the same chemicals can be produced more economically and more environmentally friendly. An example would be the substitution of protease in detergents for other cleaning compounds. Detergent proteases, which remove protein impurities, are essential components of modern detergents. They are used to break down protein, starch, and fatty acids present on items being washed. Protease production results in a biomass that in turn yields a useful byproduct- an organic fertilizer. Biotechnology is also used in the textile industry for the finishing of fabrics and garments. Biotechnology also produces biotech-derived cotton that is warmer, stronger, has improved dye uptake and retention, enhanced absorbency, and wrinkle- and shrink-resistance. Some agricultural crops, such as corn, can be used in place of petroleum to produce chemicals. The crop’s sugar can be fermented to acid, which can be then used as an intermediate to produce other chemical feedstocks for various
  • 11. 11 | P a g e products. It has been projected that 30% of the world’s chemical and fuel needs could be supplied by such renewable resources in the first half of the next century. It has been demonstrated, at test scale, that biopulping reduces the electrical energy required for wood pulping process by 30% . Environmental Biotechnology Environmental biotechnology is the used in waste treatment and pollution prevention. Environmental biotechnology can more efficiently clean up many wastes than conventional methods and greatly reduce our dependence on methods for land-based disposal. Every organism ingests nutrients to live and produces by-products as a result. Different organisms need different types of nutrients. Some bacteria thrive on the chemical components of waste products. Environmental engineers use bioremediation, the broadest application of environmental biotechnology, in two basic ways. They introduce nutrients to stimulate the activity of bacteria already present in the soil at a waste site, or add new bacteria to the soil. The bacteria digest the waste at the site and turn it into harmless byproducts. After the bacteria consume the waste materials, they die off or return to their normal population levels in the environment. Bioremediation, is an area of increasing interest. Through application of biotechnical methods, enzyme bioreactors are being developed that will pretreat some industrial waste and food waste components and allow their removal through the sewage system rather than through solid waste disposal mechanisms. Waste can also be converted to biofuel to run generators. Microbes can be induced to produce enzymes needed to convert plant and vegetable materials into building blocks for biodegradable plastics .
  • 12. 12 | P a g e In some cases, the byproducts of the pollution-fighting microorganisms are themselves useful. For example, methane can be derived from a form of bacteria that degrades sulfur liquor, a waste product of paper manufacturing. This methane can then be used as a fuel or in other industrial processes. Human Applications Biotechnical methods are now used to produce many proteins for pharmaceutical and other specialized purposes. A harmless strain of Escherichia coli bacteria, given a copy of the gene for human insulin, can make insulin. As these genetically modified (GM) bacterial cells age, they produce human insulin, which can be purified and used to treat diabetes in humans. Microorganisms can also be modified to produce digestive enzymes. In the future, these microorganisms could be colonized in the intestinal tract of persons with digestive enzyme insufficiencies. Products of modern biotechnology include artificial blood vessels from collagen tubes coated with a layer of the anticoagulant heparin. Gene therapy – altering DNA within cells in an organism to treat or cure a disease – is one of the most promising areas of biotechnology research. New genetic therapies are being developed to treat diseases such as cystic fibrosis, AIDS and cancer. DNA fingerprinting is the process of cross matching two strands of DNA. In criminal investigations, DNA from samples of hair, bodily fluids or skin at a crime scene are compared with those obtained from the suspects. In practice, it has become one of the most powerful and widely known applications of biotechnology today. Another process, polymerase chain reaction (PCR), is also being used to more quickly and accurately identify the presence of infections such as AIDS, Lyme disease and Chlamydia.
  • 13. 13 | P a g e Paternity determination is possible because a child’s DNA pattern is inherited, half from the mother and half from the father. To establish paternity, DNA fingerprints of the mother, child and the alleged father are compared. The matching sequences of the mother and the child are eliminated from the child’s DNA fingerprint; what remains comes from the biological father. These segments are then compared for a match with the DNA fingerprint of the alleged father. DNA testing is also used on human fossils to determine how closely related fossil samples are from different geographic locations and geologic areas. The results shed light on the history of human evolution and the manner in which human ancestors settled different parts of the world . Biotechnology for the 21st century Experts in United States anticipate the world’s population in 2050 to be approximately 8.7 billion persons. The world’s population is growing, but its surface area is not. Compounding the effects of population growth is the fact that most of the earth’s ideal farming land is already being utilized. To avoid damaging environmentally sensitive areas, such as rain forests, we need to increase crop yields for land currently in use. By increasing crop yields, through the use of biotechnology the constant need to clear more land for growing food is reduced. Countries in Asia, Africa, and elsewhere are grappling with how to continue feeding a growing population. They are also trying to benefit more from their existing resources. Biotechnology holds the key to increasing the yield of staple crops by allowing farmers to reap bigger harvests from currently cultivated land, while preserving the land’s ability to support continued farming.
  • 14. 14 | P a g e Malnutrition in underdeveloped countries is also being combated with biotechnology. The Rockefeller Foundation is sponsoring research on “golden rice”, a crop designed to improve nutrition in the developing world. Rice breeders are using biotechnology to build Vitamin A into the rice. Vitamin A deficiency is a common problem in poor countries. A second phase of the project will increase the iron content in rice to combat anaemia, which is widespread problem among women and children in underdeveloped countries. Golden rice, expected to be for sale in Asia in less than five years, will offer dramatic improvements in nutrition and health for millions of people, with little additional costs to consumers. Similar initiatives using genetic manipulation are aimed at making crops more productive by reducing their dependence on pesticides, fertilizers and irrigation, or by increasing their resistance to plant diseases. Increased crop yield, greater flexibility in growing environments, less use of chemical pesticides and improved nutritional content make agricultural biotechnology, quite literally, the future of the world’s food supply. (6) Modern biotechnology in medicine and health care Modern biotechnology is applied in medicine and health care in therapeutics, mainly for the discovery, development and production of novel drugs (biopharmaceuticals, but also small molecule drugs), in preventives for the development of recombinant vaccines, and in diagnostics, for protein- and nucleic acids based tests (i.e. mainly immunoassays and genetic tests). Modern biotechnology has a direct impact on the pharmaceutical sector which in 2002 created EUR 58 billion of added value or about 4% of the total value added of the manufacturing sector. In 2003, the pharmaceutical industry comprised 4111 companies in total, with 75% of these located in six EU countries (Germany, France, Spain, Italy, UK, and Poland). The 2006 EU Industrial R&D Investment Scoreboard demonstrates a similar geographic concentration: the majority of the total 64 pharmaceutical companies included in the top 1000 EU companies, ranked by R&D investment, were located in Germany (11), the UK (22) and France (9). According to Eurostat, these countries are also the largest producers of pharmaceuticals in terms of value- added. The production value of the EU pharmaceutical industry has grown
  • 15. 15 | P a g e steadily since 1993, at a higher growth rate than the average of the chemicals sector, and its trade surplus in 2004 was more than EUR 32 billion, having increased almost five times since 1990 (USA, Switzerland and Japan being the top three trading partners). Biopharmaceuticals Biomedical research has increased our understanding of molecular mechanisms of the human body, revealing many proteins and peptides produced by the human body in small quantities but with important functions, which makes them interesting for therapeutic applications. Examples are growth factors such as erythropoietin, stimulating red blood cell production, the human growth hormone, or immune system stimulating interferons. Modern biotechnology, in particular recombinant DNA technology, made it possible to produce these substances in larger quantities using microorganisms or cell cultures as “cell factories”, facilitating their therapeutic use. These products are subsumed under the term “biopharmaceuticals”. The first biopharmaceutical to reach the market was recombinant human insulin in 1982. Since then about 142 biopharmaceutical products have been launched worldwide .The main product classes of marketed biopharmaceutical products are recombinant hormones such as human insulin, monoclonal antibodies used to treat e.g. cancer but also used for diagnostic purposes, and recombinant interferons and interleukins. Economic significance of biopharmaceuticals Over the last ten years (1996-2005) in the EU, an average of six new biopharmaceutical products have been launched per year, accounting for about 9% of pharmaceuticals launched in this period (Overall, in 2005, about 85 biopharmaceutical products were available in the The combined pharmaceutical market in 2005 of the USA, the EU and Japan was about EUR 372 billion (about 80% of the worldwide market), the EU having a share of 33%. Biopharmaceuticals in the USA, EU and Japan represented a market of EUR 38.5 billion in 2005, about 10% of the corresponding pharmaceutical market. The EU has a market share of 30%, similar to the market share for pharmaceuticals. The biopharmaceutical market in the EU seems to be more dynamic than the pharmaceutical market, with average annual growth rates (23%) twice as high
  • 16. 16 | P a g e as for pharmaceuticals (11%). Accordingly, overall, the shares of biopharmaceuticals in the turnover of pharmaceuticals are increasing, indicating the growing importance of biopharmaceuticals from an economic perspective). The average turn-over per marketed biopharmaceutical in the EU has tripled over the last 10 years and, in 2005, reached a value of EUR 133 million per year. Recombinant human insulin Recombinant human insulin was the first biopharmaceutical product to reach the market, launched in 1982. Since then, it has largely replaced animal insulin; today only 30% of the worldwide available insulin is isolated from the porcine or bovine pancreas of slaughtered animals. At least 15 recombinant human insulin products are currently on the market, representing about 15% of the biopharmaceutical market by value. In developed countries animal-based insulin is hardly available any more. Insulin is primarily targeted at Type 1 diabetes patients, mainly children and adolescents (about 5-10% of all diabetes patients) who have lost their ability to produce insulin and need regular injections of insulin. About 30% of Type 2 diabetes patients require additional insulin to regulate their blood glucose levels. The underlying cause of Type 2 diabetes is an acquired loss of sensitivity to the hormone insulin, which affects adults usually over the age of 40 and is linked to diet and body weight. In 2003, there were about 194 million diabetes patients worldwide; this figure is expected to increase to more than 330 million by 2025 due to an increase of obesity worldwide. Complications from diabetes, such as stroke, renal failure, blindness, coronary artery and peripheral vascular disease, often reduce quality of life and life expectancy and entail considerable health care costs. Although recombinant human insulin does not appear to have significant therapeutic differences compared to animal insulin, clinical adoption of recombinant insulin is high: about 95% of Type 1 diabetes patients in the EU use recombinant insulin. Recombinant human insulin seems to be more expensive than animal insulin in most countries where both are available, e.g. in European countries (including non-EU countries) the average price of recombinant human insulin was twice as high as for animal insulin. One
  • 17. 17 | P a g e explanation for the widespread adoption could be the potentially improved safety of recombinant insulin regarding the risk of immune reaction and contamination of animal insulin. It is also important to realise that, according to a study carried out in the USA, the actual cost of insulin, including delivery, amounts to only 7.6% of diabetes-related health care expenditures. Recombinant human insulin is the starting point for the development of human insulin analogues, which reached the market several years ago. The analogues are developed by using genetic engineering to produce fast acting and slow acting human insulin. They are designed to improve the control of insulin requirements over the day, with obvious advantages for the patients. However, the generally higher prices may reduce their cost-effectiveness, especially in the case of diabetes type 2 patients. Recombinant human insulin and insulin analogues are effective in the treatment of diabetes; however, for these products there is currently limited experimental evidence showing additional efficacy compared with conventional animal insulin. Hence, the contribution of biotechnology-derived insulin products to reducing the burden of diabetes per se compared to animal insulin may need to be considered marginal. However, insulin analogues may improve the quality of life of diabetes patients, which could be seen as the major contribution of recombinant insulin. Judging such qualitative improvements would require more specific cost- utility analyses and more fundamental ethical decisions. Interferon-beta for multiple sclerosis Until 1993, when interferon-beta reached the market, multiple sclerosis (MS) was treated with corticoids to accelerate recovery from relapses. Corticoids do not cure MS, and neither do any of the treatments currently available. Also, interferon-beta belongs to the group of disease modifying drugs: it does not cure MS, but it may slow down the development of some disabling effects and decrease the number of relapses. As such, it has developed into the first line treatment for MS. Currently, four interferon-beta products are available, representing about 8% of the biopharmaceutical market by value. Multiple sclerosis (MS) is an autoimmune disease that affects the central nervous system. Its onset occurs primarily in young adults and it affects women
  • 18. 18 | P a g e more often than men. The exact cause of the disease is unknown, but a genetic predisposition is suspected. The disorder can manifest in a remitting or progressive development, and it is characterised by lesions that occur throughout the brain and spinal cord, which have severe consequences such as loss of memory or loss of balance and muscle coordination; other symptoms include slurred speech, tremors, and stiffness or bladder problems. Estimates of the prevalence of MS in the EU differ between about 2,57,000 in Western Europe to over 5,63,000 cases in the EU. Given the number of people who suffer from MS and the fact that it primarily affects young adults, the individual consequences of this disease are severe and the economic and social costs are substantial. This is also reflected in the high share of “indirect” costs – i.e. of costs that occur outside the health care system, like productivity losses, costs for informal health care or estimates of intangible costs – that usually make up more than half of total costs. Regarding cost-effectiveness, no conclusive studies have been identified. The use of interferon- beta for the treatment of MS is not without controversy. In 2002, the UK’s National Institute for Health and Clinical Excellence (NICE) issued a guidance not recommending interferon-beta or the current alternative treatment glatiramer acetate (available since 2000 in some EU Member States) for the treatment of MS based on clinical performance and cost-effectiveness considerations. More recent evaluations show modest benefits of interferon-beta for the progression of MS in the short to medium term. (7)
  • 19. 19 | P a g e Conclusion: Finally we can come to an end by saying that- most of the educated people regardless of gender are unaware of the importance of biotechnology in any aspects of our society, even though it is crystal clear that its technological value has foreseen for a long time to motivate the upcoming generations. It is certain that human existence and survival on the coming days rest on the development and rapidly advancement of biotechnology. Because of the advancement of thorough researched and development, the importance of biotechnology has come to existence. It is a field in biology that is extensively used in engineering, medicine, science and technology, agriculture and other valuable form of applications. Biotechnology can be a great solution to mankind struggles. So, what does it’s all about? Briefly, it is merely an applied principles of chemistry, physics and engineering comprise into biological structure. Application in modern era includes the field of genetic engineering. It is the usage of this technology to culture cells and tissues for the modification living organism for human purposes. By this, the importance of biotechnology in agriculture increases the crop production which makes it double or even higher than normal harvest. It has the ability to give biological protection from disease and pests, so a minor necessity for chemical insecticides. Biotechnology is capable of conveying genetic qualities of the crops that can withstand the changing climate condition, obtain an increase of nutritional qualities. This will provide the farmers a healthy lifestyle due to the less exposure of chemical residues and eventually give a higher profit. Benefits of biotechnology can also be experienced in the medical institution. Its technological application includes pharmaceutical products and medicines, and human therapy. It helps produced large quantity of protein for nutritional supplements and insulin for diabetic patient treatment. The gene therapy, in which is the most successful result of biotechnology research use to cure aids and cancer. Application on biotechnology can be seen in industrial plant and factories. They are used to give an improved effectiveness and competence in production process while reducing the impact to the environmental issues. Waste products can be treated and recycled as a help to preserve natural resources.
  • 20. 20 | P a g e It is beyond expectation on what the biotechnology has accomplished and reached in just a matter of time. Humanity has just start to comprehend and recognized the endless opportunities it has open. As technology assures to provide solution to every frightening problem we face every now and then, so is mankind is expecting a more develop biotechnology in the future. A technology that is more reliable and firm. This is the importance of biotechnology; revolution of the future technology. (8)
  • 21. 21 | P a g e Reference: 1) Dresden Biotechnology Centre http://www.biotec.tu-dresden.de/technology-platform/ 2) De Montfort University http://www.dmu.ac.uk/study/courses/postgraduate- courses/pharmaceutical-biotechnology.aspx 3) Wikipedia https://www.google.com.bd/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&uact=8& ved=0CCYQFjAA&url=http%3A%2F%2Fen.wikipedia.org%2Fwiki%2FBiotechnology&ei=Op5 QU89i0puJB5H- gIAH&usg=AFQjCNGplF2VLcYqkSmvXq3Wsxbd5zYvCg&sig2=dQMG2jZUQZPqwqs- whiGNQbiotechnology.aspx 4) yonsei school of Life science & Biotechnology https://www.google.com.bd/url?sa=t&rct=j&q=&esrc=s&source=web&cd=8&cad=rja&uact=8& ved=0CGIQFjAH&url=http%3A%2F%2Fuic.yonsei.ac.kr%2Fimages%2FUD_Life_Science_and _Biotechnology.pdf&ei=CJxQU7H2NomDiQe5soCwDA&usg=AFQjCNH5eZPVNrV2jTgfaEEL iZxekAGrbw&sig2=WzalBIin6n_CkFPrHGXqPw 5) Yale Bioinformatics http://www.primate.or.kr/bioinformatics/Course/Yale/intro.pdf 6) The North Carolina Cooperative Extension Service North Carolina State University http://www.ces.ncsu.edu/depts/foodsci/ext/pubs/bioapp.html 7) Consequences, Opportunities and Challenges of Modern Biotechnology for Europe By- Eleni Zika, Ilias Papatryfon, Oliver Wolf, Manuel Gómez-Barbero, Alexander J. Stein and Anne-Katrin Bock http://ebookbrowsee.net/consequences-opportunities-and-challenges-of-modern-biotechnology- for-europe-pdf-d631986284 (8)Importanceoftech.com http://importanceoftech.com/importance-of-biotechnology