unit 1 SCOPE OF BIOTECHNOLOGY .pdf

1/6/2022 Concept
development and
scope of
Biotechnology
MOD 1.NEP
SH/BT/NEP
[COMPANY NAME]

CONCEPT DEVELOPMENT AND SCOPE OF BIOTECHNOLOGY
SH/BT/NEP 1
Biotechnology: The scope and applications
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 living 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.
Biotechnology is defined as the ‘application of scientific and engineering principles to the processing of
material by biological agents to provide goods and services’
Development of biotechnology
The development of biotechnology can be divided into broad stages or categories, including:
Ancient biotechnology (8000–4000 BC): Early history as related to food and shelter; includes
domestication of animals.
Classical biotechnology (2000 BC; 1800–1900 AD): Built on ancient biotechnology; fermentation
promotes food production and medicine.
1900–1953: Genetics.
1953–1976: DNA research, science explodes
Modern biotechnology (1977): Manipulates genetic information in organisms; genetic engineering;
various technologies enable us to improve crop yield and food quality in agriculture and to produce a
broader array of products in industries.
Branches of Biotechnology
The definition of biotechnology can be further divided into different areas known as red, green blue
and white.
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.
Green biotechnology: Green biotechnology applies to agriculture and involves such processes as the
development of pest-resistant grains and the accelerated evolution of disease-resistant animals.

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Blue biotechnology: Blue biotechnology, rarely mentioned, encompasses processes in the marine and
aquatic environments, such as controlling the proliferation of noxious water-borne organisms.
White biotechnology: White (also called gray) biotechnology involves industrial processes such as the
production of new chemicals or the development of new fuels for vehicles.
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.
Scope of Biotechnology:
Genetic engineering in biotechnology stimulated hopes for both therapeutic proteins, drugs and
biological organisms themselves, such as seeds, pesticides, engineered yeasts, and modified human cells
for treating genetic diseases. The field of genetic engineering remains a heated topic of discussion in
today’s society with the advent of gene therapy, stem cell research, cloning, and genetically-modified
food.
Biotechnology is the applied science and has made advances in two major areas, viz., molecular biology
and production of industrially important bio-chemical. The scientists are now diverting themselves
toward biotechnological companies; this has caused the development of many biotechnological
industries.
In USA alone more than 225 companies have been established and successfully working, like Biogen,
Cetus, Genetech, Hybritech, etc. In world, USA, Japan, and many countries of Europe are leaders in
biotechnological researchers encouraged by industrialists.
The advances in recombinant DNA technology have occurred in parallel with the development of genetic
processes and biological variations. The development of new technologies have resulted into production
of large amount of biochemically-defined proteins of medical significance and created an enormous
potential for pharmaceutical industries.
Biotechnology in itself is a vast subject and its scope is extended to various branches of biology. This
includes plant tissue culture, production of transgenic in animal and plants, applications in medicine as
tools and therapeutics, creation of new enzymes and their immobilization for industrial use,
development of monoclonal antibodies and control of pollutions, etc.

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Table: Applications of biotechnology in different areas.
Area Applications
Plant
biotechnology
Transgenic plants, production of secondary metabolite, production of pathogen-free plants
or crop improvement, production of herbicide-resistant crops, pest-resistant ('Bt concept'
pest-resistant transgenic) plants, drought resistance, flood resistance, salt tolerance, high-
yielding GM crops, nitrogen fixing ability, acidity and salinity tolerance, in vitro germplasm
conservation, genetic variability, in vitro pollination, induction of haploidy, somatic
hybridization, genetic transformation, molecular pharming, somatic embryogenesis,
organogenesis, phytoremediation, in vitro plant germplasm conservation, mutant selection,
somaclonal variation, plant genome analysis, hybrid seeds, artificial seeds
Animal
biotechnology
Biopharmaceuticals: Production of hormones, growth factors, interferons, enzymes,
recombinant proteins, vaccines, blood components, oligonucleotides, transcription factor-
based drugs, oligonucleotides
Antibiotics
Replacement therapies: Lack of production of normal substances (factor VIII—missing in
hemophilia, insulin)
Diagnostics: antibodies, biosensors, PCR, therapeutics, vaccines, medical research tools,
human genome research, development of biosensors
IVF, ET
Gene therapy
Stem cell therapy
Animal tissue culture: Cell, tissue and organ culture
Gene cloning: rDNA technology, genetic engineering, transgenic animals, antibiotics, DNA
markers, animal husbandry, xenotransplantation, medical biotechnology
Therapeutics: Natural products such as from the foxglove (Digitalis, heart conditions) and
yew tree (cancer agent, taxol) for breast and ovarian cancers, endogenous therapeutic agents
i.e. proteins produced by the body that can be replicated by genetically engineering, tPA—
tissue plasminogen factor (dissolves blood clots), biopharmaceuticals (drug or vaccine
developed through biotechnology), therapeutants, i.e. products used to maintain health or
prevent disease, biopharming, i.e. production of pharmaceuticals in cultured organisms,
certain blood-derived products needed in human medicine can be produced in the milk of
goats
Biopolymers and medical devices: natural substances useful as medical devices: hyaluronate,
an elastic, plastic-like substance used to treat arthritis, prevent post-surgical scarring in
cataract surgery, used for drug delivery, adhesive substances to replace stitches
Designer drugs: Using computer modeling to design drugs without the lab-protein structure

SH/BT/NEP 4
Area Applications
Evolutionary and ecological genomics: Finding genes associated with ecological traits and
evolutionary diversification. Common goals are health and productivity
Agricultural
biotechnology
The applications of animal biotechnology, crop biotechnology, horticultural biotechnology,
tree biotechnology, food processing, plant biotechnology (photosynthesis improvers, bio-
fertilizers, stress-resistant crops and plants, bio-insecticides and biopesticides), food
biotechnology
Food: Increased milk production, leaner meat in pork, growth hormones in farm-raised fish
that result in earlier market-ready fish
Pharmaceuticals: Animals engineered to produce human proteins for drugs, including insulin
and vaccines
Breeding disease tolerance, exact copies of desired stock, increased yields
Health: Micro-organisms introduced into feed for beneficial purposes, diagnostics for disease
and pregnancy detection, animals engineered to produce organs suitable for transplantation
into humans
Environmental
biotechnology Environmental monitoring: Diagnosis of environmental problems via biotechnology
Waste management: Bioremediation is the use of microbes to break down organic molecules
or environmental pollutants
Pollution prevention: Renewable resources, biodegradable products, alternative energy
sources
Fuel and
fodder
Provides a clean and renewable alternative to traditional fossil fuels, the burning of which
contributes to global warming
Tissue culture technique offers rapid afforestation of degraded forests and regeneration of
green cover
Biotechnology could play an important role in three ways in the productivity of biomass
Can be used to generate methane
Industrial
biotechnology
Metabolite production (acetone, butanol, alcohol, antibiotics, enzymes, vitamins, organic
acids), anaerobic digestion (for methane production), waste treatment (both organic and
industrial), production of bio-control agents, fermentation of food products, bio-based fuel
and energy, industrial microbiology, biotechnology in the galvanizing industry, recovery of
metals and minerals, bioethanol, bioconversion of synthesized gas to liquid fuels such as
methanol, using bacteria to remove byproducts, pulp and paper, sugars from starches,
animal feed, food, textiles and leather, pharmaceuticals, an enzymatic process for producing
antibiotics

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Area Applications
Aquatic
biotechnology
Aquaculture, restoring and protecting marine ecosystems, improving seafood quality,
environmental remediation, marine byproducts for human health, biomaterial and
bioprocessing, marine molecular biotechnology
Applications:
Industrial Applications of Biotechnology:
The industrial application of molecular biotechnology is often subdivided, so that we speak of red, green,
gray or white biotechnology. This distinction relates to the use of the technology in the medical field (in
human and animal medicine), agriculture, the environment and industry.
Some companies also apply knowledge deriving from molecular biotechnology in areas that cut across
these distinctions (e.g., in red and green biotechnology, sequencing services). According to an
investigation by Ernst and Young relating to the German biotech industry, 92% of companies are currently
(2004) working in the field of red biotechnology, 13% in green, and 13% in gray or white biotechnology.
Biotechnology in Medicine:
Biotechnology products for therapeutic use include a very diverse range of products, as outlined in
Tables 22.4, 22.5. Some products are intended to mimic the human counterpart, whereas others are
intended to differ from the human counterpart and may be analogues, chemically modified (e.g.,
pegylated) or novel products (e.g., single chain or fragment antibody products, gene transfer vectors,
tissue-engineered products).
Biotechnology-derived pharmaceuticals may be derived from a variety of expression systems such as
Escherichia coli, yeast, mammalian, insect or plant cells, transgenic animals or other organisms. The
expressed protein or gene may have the identical amino acid or nucleotide sequence as the human
endogenous form, or may be intentionally different in sequence to confer some technical advantage such
as an optimized pharmacokinetic or pharmacodynamics profile.
The glycosylation pattern of protein products is likely to differ from the endogenous human form due to
the different glycosylation preferences of the expression system used. Furthermore, intentional post-
translation modifications or alterations may be made such as pegylation. It is important for the
toxicologist to be aware of the nature of the product to be tested in terms of primary, secondary and
tertiary structure, and any post-translational modifications such as glycosylation status, particularly as
these may be altered if the manufacturing system is modified.

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Biopharmaceutical Drug Development:
In the field of biopharmaceutical development, it is the development of therapeutic human proteins by
recombinant methods. (Table 22.5) for use as medicines that has the longest tradition. As mentioned
above, recombinant human insulin was the first recombinant medicine in the world, produced by
Genentech and brought to market in 1982. Today, recombinant human insulin has almost completely
driven the other preparation of insulin (isolated from human or animal tissues) from the market.
The first therapeutic antibodies, especially monoclonal antibodies, have been on the market since the
late 1990s. In 2002, antibodies were (along with vaccines) the most important therapeutic class of drugs
under development and there are also more recent market studies more than 100 antibodies or antibody
fragments were at the clinical development stage in 2002 and research and development is being carried
out on around 470 more in about 200 companies around the world (Table 22.6,7).
Since the introduction of therapeutic antibodies onto the market, they have achieved significant
turnovers, which are growing continually. The market for 2008 is estimated at a volume of US $16.7 billion
(from Data-monitor, November 2003). Today, in addition to proteins, which currently play the most
significant role in the biopharmaceutical field, new types of drugs based on RNA (antisense drugs,
ribozymes, aptamers, Spiegelmers and RNA interference) are also being developed on the basis of
advances in knowledge on molecular biotechnology.

SH/BT/NEP 7
Drug Delivery:
Closed linked to the development of therapeutic agents are the means of achieving their targeted
delivery to their site of action. These drug delivery systems are mainly used for drugs whose physical and
chemical characteristics make them insufficiently stable in reaching their site of action intact. They can
also be used to transport drugs in a targeted way to particular sites of action (tissue specific targeting),
or to overcome biological barriers such as the intestinal wall or the blood-brain barrier.
Green Biotechnology:
Green biotechnology is the application of biotechnology processes in agriculture and food production.
The main dominant forces in green biotechnology today are agro giants with a world¬wide area of
operation such as BASF, Bayer Crop-Science, Monsanto and Syngenta. They are concentrating
considerable attention on molecular plant biotechnology, which is seen as a future growth factor in agro-
industry. The traditional pesticide market, on the other hand has been stagnating for years.
Transgenic Plants:
The main emphasis in modern plant biotechnology is the production of transgenic plants. The first use of
gene technology to bring about changes in plants became possible at the beginning of the 1980s, around
ten years after the first experiment with bacteria. The market value of transgenic plants is estimated to
be in excess of 2 billion euros, according to the calculation of the German Federal Office for the
Environment. These figures relate to transgenic crop plants, which were being grown on an area totaling
about 40 million hectares worldwide in 1999 and 2000.
Novel and Functional food:
New types of foodstuffs with novel properties are often called functional food. Another category that is
often mentioned in this context is nutraceuticals. These are foods that have a medicinal effect.
Livestock Breeding:
Modern biotechnology is being employed commercially to introduce novel performance features in
productive livestock. The transgenic specimens then display for example different wool characteristics
for sheep, or improved milk characteristics in cattle.
Grey/White Biotechnology:
The terms Grey and White Biotechnology have been coined for the application of biotechnological
processes in environmental and industrial production contexts. The latter is primarily focused on the
production of fine chemicals, in particular technical enzymes.
Technical Enzymes:
Modern biotechnology already dominates the technical enzymes market. They can be found as
proteases, lipases, celluloses and amylases for example in modern detergents, where the serve, amongst
other purposes as protein and fat solubilizes.
Safety Concerns:
There are a number of safety issues relating to biotechnology products that differ from those raised by
low molecular weight products and need to be taken into account when designing the safety
evaluation programme for a biotechnology derived pharmaceutical product.

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The quality and consistency of the product requires careful control in terms of product identity,
potency and purity because of concerns about microbiological safety, impurities arising from the
manufacturing process (e.g., host-cell contaminants, endotoxin, residual DNA levels and process
chemicals), and the fidelity of the protein sequence and post-translational modifications during process
improvements and scale-up.
Biotechnology In India
The remarkable march of India into the world of biosciences and technological advances began in 1986.
That year, the then Prime Minister of the country, late Rajiv Gandhi accepted the vision that unless India
created a separate Department for Biotechnology, within the Ministry of Science and Technology,
Government of India the country would not progress to the desired extent. This was because many of
our macro-economic issues of growth were subsumed within that science’s development.
That decision has made India one of the first countries to have a separate department for this stream of
science and technology. However the initiation of deliberations to establish the department started
much earlier In 1982, after detailed deliberations with the scientific community, and on the basis of
recommendations by the then Scientific Advisory Committee to the Cabinet, a National Biotechnology
Board (NBTB) was constituted by the Government to identify priority areas and evolve long term

SH/BT/NEP 9
perspective for Biotechnology in India. It was also responsible for fostering programmes and
strengthening indigenous capabilities in this newly emerging discipline.
The NBTB was chaired by the formidable scientist Professor MGK Menon, the then Member (Science) of
India’s Planning Commission. All the Secretaries to the various departments of the government dealing
with science were appointed as Members of this Board. A separate Department of Biotechnology (DBT)
was finally set up in February, 1986 and the NBTB selected Dr S Ramachandran as the first Secretary of
the department. The DBT constituted a ten member Scientific Advisory Committee (SAC) with heads of
various scientific agencies and a seven member Standing Advisory Committee for North America SAC (0)
to ensure that the Department kept abreast of global developments in the field of Biotechnology.
Dr S Ramachandran, says that Prime Minister Shri Rajiv Gandhi recognised that the pace at which
biological sciences were growing globally, that “unless we leap forward, there is no way of catching up
with the rest of the world”. So space was allocated to a small team to sit in the now sprawling and
modern CGO Complex, at Lodhi Road, New Delhi, to set up the DBT. According to Dr Ramachndran the
Department started with a modest beginning of around Rs 4 to 6 crore as its first budget.
There has been a paradigm shift in the relationship between Government, Academia, Industry, Startups
and Civil Society. The Department has made special efforts to contribute through its various programmes
to the National Missions launched by the Hon’ble Prime Minister-Swasth Bharat, Swatch Bharat, Startup
India, Make in India and Digital India. The Department through its Public Sector Undertaking-BIRAC has
created a vibrant ecosystem for innovation to thrive in our country.
Our continuous effort is to engage with all stakeholders as we move forward in our journey to make India
a US$100b Bioeconomy by 2025.
Refrences:
1. https://iopscience.iop.org/book/978-0-7503-1299-8/chapter/bk978-0-7503-1299-8ch1
2. https://dbtindia.gov.in/about-us/

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