A Course Guide for Pharmaceutical Biotechnology

Course Code: Biot.3112

Course credit: 3 credit hours/week (5 ECTS

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Biotechnology

Some definitions of biotechnology are as follows:

1. Biotechnology means any scientific application that uses biological

systems, living organisms or derivatives thereof, to produce or alter
products or processes for particular use
2. The utilization of living organisms, systems or processes constitutes
biotechnology’
3. Based on the Collins English Dictionary definition, biotechnology is the
employment of living organisms, their parts or processes, to develop
active and useful products and to provide services e.g. waste treatment.
The term signifies a broad range of processes, from the use of earthworms
as a source of protein to the genetic modification of bacteria to offer
human gene products, e.g. growth hormones.
4. According to the Golden Treasury of Science and Technology [7],
biotechnology is a discipline based on the harnessing of life processes
which are controlled for the bulk production of valuable substances.

Biotechnology
 A fusion or an alliance between Biology (bioScience)and
technology(bioTechnology)
 Is as old as human civilization and is an integral part of human life
 Is a newly discovered discipline for an age-old practices such as:
 Wine and beer production- before 6000 B.C.
 Bread and curd making - ‘’ 4000 B.C.
 Production of foods and beverages
 Modification of plants and animals etc.
 Today, these processes are based on the natural capabilities of
microorganisms

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  Is not itself a product or range of products like microelectronics
 It should be rather regarded as a range of enabling technologies that
will find significant application in many industrial sectors
It is obvious from the above definitions that biotechnology includes different
technologies that rely on information gained by modern discoveries in
biochemistry, cell biology and molecular biology. These technologies are
already having a huge impact on diverse areas of life, including agriculture,
food processing, medical technology and waste treatment.

 Biotechnology consists of ‘the controlled employment of biological

agents, e.g. micro-organisms or cellular components, for favorable use’.
 Biotechnology has been defined as ‘Janus-faced’ [9]. This means that
there are two sides to it. On one side, we know that the technology allows
DNA to be modified so that genes can be moved from one organism to
another. On the other, it also entails comparatively new techniques whose
results are untested and should be met with care.
 Biotechnology is ‘the integrated use of microbiology, biochemistry and
engineering sciences in production or as service operation’.
 Biotechnology is the commercial employment of micro-organisms and
living plant and animal cells to create substances or effects beneficial to
people. It includes the production of antibiotics, vitamins, vaccines,
plastics, etc.
 ‘Bio’ refers to life and ‘technology’ refers to the application of
information for practical use, i.e. the application of living organisms to
create or improve a product.
 It involves the industrial application of living organisms or their products,
which entails the intentional manipulation of their DNA molecules. It
may mean making a living cell execute a particular task in a predictable
and controllable way.

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 The term biotechnology is occasionally also applied to processes in which
micro-organisms such as yeasts and bacteria are cultured under strictly
controlled environmental conditions. For this reason, fermentation is
occasionally called the oldest form of biotechnology. Genetic engineering
techniques are frequently, but not always, used in biotechnology.
 The Universities Press Dictionary of Biology defines biotechnology as
‘the application of technology to biological processes for industrial,
agricultural and medical purposes’.
 The Oxford Dictionary of Biology [13]defines biotechnology as ‘the
development of techniques for the application of biological processes to
the production of materials of use in medicine and industry.’
 The employment of cells and biological molecules to explain problems or
make valuable products. These biological molecules include DNA, RNA
and proteins.
 Biotechnology may be defined as ‘the utilization of living organisms in
systems or processes for the production of valuable products; it may
involve algae, bacteria, fungi, yeast, cells of higher plants and animals or
subsystems of any of these or isolated components from living matter’

 It may be seen that the diverse definitions of biotechnology above differ

in their approach, content and emphasis. But there are two main
characteristics common to them all are. First, biotechnology involves the
exploitation of biological entities (i.e. micro-organisms, cells of higher
organisms—either living or dead), their components or constituents (e.g.
enzymes), in such a way that some functional product or service is
generated. Second, this product or service should aim to improve human
welfare.

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In summary, biotechnology is the application of the theory of engineering
and biological science to generate new products from raw materials of
biological origin, e.g. vaccines or food’, or, in other words, it can also be
defined as ‘the exploitation of living organism/s or their product/s to
change or improve human health and human surroundings’

Hungarian engineer Karl Ereky first coined the term ‘biotechnology’ in

1919, meaning the production of products from raw materials with the aid
of livin organisms. As mentioned above, biotechnology is not new, since
human civilization has been exploiting living organisms to solve
problems and improve our way of life for millennia. The production
technologies and processes involved in animal husbandry, agriculture,
horticulture, etc, utilize plants and animals to produce useful products.
However, such technologies are not regarded as biotechnology since they
are long recognized and well-established disciplines in their own right.
Today, the exploitation of animal and plant cells cultured in vitro as well
as their constituents for generating products/services is an integral part of
biotechnology.

Branches of biotechnology
A large number classification of biotechnology is available, but the
classification based on color code is widely used. This is known as
Rainbow code of biotechnology. The definition of biotechnology can be
further divided into different areas known as red, green, blue and white.
1. Red biotechnology: This area includes medical procedures such as
utilizing organisms for the production of novel drugs or employing
stem cells to replace/regenerate injured tissues and possibly regenerate
whole organs. It could simply be called medical biotechnology. Red or
medical biotechnology is related to the application of biological

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 techniques that can be used for the diagnosis, prevention, and
treatment of diseases. Generally, medical biotechnology deals with
proper use of the recombinant DNA technology in different
therapeutic processes. The best-known products of medical
biotechnology are antibiotics that are used to treat bacterial infections.
Some exceptional products of medical biotechnology can be produced
outside the body like insulin. The desirable applications of medical
biotechnology are needed for a substantial degree of organization,
regulation and making of careful policy and execution. The
probabilities and possibilities behind this kind of attention towards
medical biotechnology may be due to its potential to encourage the
wealth as well as health problems.

2. Green biotechnology: applies to agriculture and involves such

processes as the development of pest-resistant grains and the
accelerated evolution of disease-resistant animals.
3. Blue biotechnology: is rarely mentioned, encompasses processes in
the marine and aquatic environments, such as controlling the
proliferation of noxious water-borne organisms.
4. White biotechnology: White biotechnology involves industrial
processes such as the production of new chemicals or the
development of new fuels for vehicles.
5. Gray biotechnology: Gray or environmental biotechnology is
related to environment applications. It can be divided into two basic
ways: the maintenance of biodiversity and the elimination of
pollutants using microorganisms (bioremediation). Gray
biotechnology plays a vital role in solving environmental problems
through the application of biological systems in waste treatment and
management, and for the protection and restoration of the

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 environment. Organisms and their environments are dynamic and
interdependent. It includes everything (biotic as well as abiotic
factors) that surrounds an organism. It is an eco-friendly method has
reduced the overexploitation and pollution of the ecosystem and is
using various methods such as Bioremediation, phytoremediation,
biodiversity and microbial ecology and its activities in protecting the
environment.
6. Violet biotechnology: Violet biotechnology is related to law, ethical
and philosophic issues. Biotechnology achieved significant progress
in various areas like industrial, agricultural production, fight against
disease. Some social, ethical, moral and religious issues also exist in
the field.
7. Dark biotechnology: Dark biotechnology is related to bioterrorism
and biological weapons. This field is easy to access and creates a
wide range of disease producing biological agents with low
production costs and easy transportation from one place to another.
The raw materials which are used in this field are use of microbes
and toxins, especially microorganisms, plant and animal origin to
produce disease and death in humans, crops and living things.

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8. Yellow biotechnology: It is an older branch of biotechnology which
deals with production of human and animal food. The main purpose
of yellow biotechnology is improvement of certain food to obtain the
most nourishing one. Besides, In this branch techniques are used to
produce or modify a food, from living substance or develop
microorganisms involved in its preparation, such as functional foods,
are those who without therapeutic capacity, improve health or prevent
against certain diseases.
9. Golden Biotechnology (bioinformatics)- is the combination of
computers and biotechnology. It helps in finding the analysis of data

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 related to Biotechnology. It uses for various purposes like drugs, for
the development of medicines.
[Link] Biotechnology- deals with the management of arid lands and
deserts

Traditional vs. Modern Biotechnology

1. Old/ Traditional Biotechnology

 Refers to the natural processes or conventional techniques that
have been in use for many centuries to produce beer, curd, wine,
cheese, many other foods and drinks
 Is the use of organisms and their products:
 To make or improve plants, animals or microorganisms
 For agricultural, industrial and environmental purposes
 The classical biotechnology that emerged during the early twentieth
century was basically a microbial-based fermentation process in
which the principles of biochemical engineering have been applied
to change it into an industrial process
 In short, it is a hybrid of fermentation and biochemical
engineering.
2. New/ Modern Biotechnology/molecular biotechnology

 Involves genetic engineering methods such as rDNA, MCA and cell and
tissue culture

 Embraces all methods of genetic modifications by rDNA and cell fusion

techniques

 Is changing the structure and parts of cells to change the organism.

 Modern biotechnology embraces all the:

 Genetic manipulations,

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  Cell fusion techniques and
 The improvements made in the old biotechnological
processes
A distinction is made between ‘non-gene biotechnology’ and ‘gene
biotechnology’:
Non-gene biotechnology: Non-gene biotechnology works with
whole cells, tissues or even individual organisms. Non-gene
biotechnology is the more popular practice, involving plant
tissue culture, hybrid seed production, microbial fermentation,
production of hybridoma antibodies and immunochemistry.
Gene biotechnology: Gene biotechnology deals with genes,
the transfer of genes from one organism to another and genetic
engineering.

The scope of Biotechnology

 The scope of biotechnology is represented by a big tree where the:

1/ The root - includes scientific foundations of biotechnology:
 Biochemical engineering
 Physiology
 Immunology
 Cell biology
 Molecular biology
 Biochemistry
 Genetics
 Bioinformatics
 Chemical engineering
 Food science
 Material science
 Etc
2/ The growing plant with stem, branches etc. includes biotechnological tools:

 Protein engineering

 Bioprocess fermentation technology

 Biosensor technology

 Monoclonal antibody technology

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  Cell and tissue culture technology

 Transgenesis technology

 Antisense technology

 DNA chip technology

 Immunotechnology

 Metabolic engineering

 Etc.

3/ The fruits include applications of biotechnology:

 Agricultural –health of animals & plants
_ food quality
_ crop yield
 Environmental – bioremedation
_ environmental monitoring
_ pollution control
 Medical and health _ therapeutics
_vaccines
_foods
_ diagnostics

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Biotechnology, like other advanced technologies, has the potential for misuse.
Concern about this has led to efforts by some groups to enact legislation
restricting or banning certain processes or programs, such as human cloning and
embryonic stem cell research. There is also concern that if biotechnological
processes are used by groups with nefarious intent, the end result could be
biological warfare. Apart from their beneficial applications, biotechnological
principles also have the potential for destruction, the best example of which is
bioterrorism. A representation of the potential pitfalls of biotechnology in
fiction can be found in the novel Frankenstein [18, 19]. In this science fiction
story, the character of Frankenstein has created a human life which becomes a
monster; this monster becomes the cause of the destruction of Frankenstein, the
creator of human life. The real-life changes that can be brought about by
biotechnology can easily be seen in figure 1.1, illustrating a 14-month-old
genetically engineered (‘biotech’) salmon (left) and a standard salmon (right).

Biotechnology and its various stages of development

It is well known that the technical application of biological material is

considered to be biotechnology. To understand how biotechnology works it is

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important to think about the starting point or material for biotechnology
processes. Generally, biotechnology utilizes living material or biological
products to generate new products for use in various medical, agricultural,
pharmaceutical and environmental applications. The ultimate goal of
biotechnology is to benefit humanity by, for example, the production of resistant
crops, vegetables, recombinant proteins, higher milk-producing animals, etc.
Different developmental stages have taken place in biotechnology to meet the
various needs of humans at the time. Its development was principally based on
observations, and the application of these observations to practical scenarios.
Owing to the evolution of new technologies and a better understanding of
various principles of life science, the complexity of biotechnology has
increased.

The historical foundations for the development of Biotechnology

Year Development

6000 BC Wine preparation using yeast

4000 BC Bread baking employing yeast
1670-1680 Use of microorganism for cupper mining
1865 Inheritance of genetic characteristics of Gregor Mendel
1876 Lious Pasteur identified role of microorganisms in
fermentation
1897 Extraction of enzymes from yeast by Edward Buchner
1910 Sewage purification by employing microorganisms
established
1914 Production of industrial chemicals(acetone, butanol,
glycerol) using bacteria
1917 The term biotechnology was coined by Karl Ereky
1928 Discovery of penicillin by Alexander Fleming
1943 Industrial production of penicillin
1944 Identification of DNA as a genetic material
1953 Determination of DNA structure by Watson and Crick
1958 Semiconservative replication of DNA by Messelson and

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 Stahl
1961 Lac. Operon model for gene regulation, proposed by Jacob
and Monod
1961 Launching of the journal of Biotechnology and
Bioengineering
1962 Microbial mining of uranium
1962-1966 Entire genetic code deciphered
1970 Isolation of the first restriction endonuclease enzyme
1972 Synthesis of tRNA gene by Khorana et. Al
1973 Establishment of rDNA technology by Boyer and Cohen
1975 Production of monoclonal antibodies by Kohler and Milstein
1976 National guidelines for rDNA research by USA
1976 Sanger and Gilbert developed techniques to sequence DNA
1977 First genome (of bacteriophage QX174)
1978 Production of human insulin in [Link]
1980 Site directed mutagenesis by Gilam [Link]
1980 Patent for genetically engineered microorganisms
1981 First diagnostic kits based on monoclonal antibodies approved in
U.S
1982 Approval of first animal vaccine produced by rDNA technology for
human use
1983 Use of Ti plasmids to genetically transform plants
1987 Gene transfer by biolistic transformation
1988 Development of PCR
1988 U.S. patent granted to genetically engineered mouse(susceptible to
cancer)
1990 Approval granted in U.S. for trail of human somatic cell gene
therapy
1990 Official launchnig of human genome project
1992 First chromosome (of yeast) sequenced

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1994-95 Genetic and physical maps of human chromosomes elucidated
1996 First eukaryotic organism( Saccharomyces cerevisiae) sequenced
1997 The first mammalian sheep, dolly developed by nuclear cloning
2000 First plant genome(of Arabidopsis thaliana) sequenced
2001 Human genome, the first mammalian genome, sequenced
2002 First crop plant (rice, Oryza sativa) genome sequenced
2003 Mouse (Mus musculis) genome, the experimental animal closest model
to man, sequenced
2004 Large – scale sequencing of Sargasso Sea metagenome begins
2005 NCBI announces that there are 100 gigabases of nucleotides in the
GenBank sequence database
2006 Recombinant vaccine becomes available to protect against cervical
cancer
2008 Two- billionth acre of genetically engineered crops is planted
2009 FDA approves first drug produced in a genetically engineered
animal(goat)

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