BIOTECHNOLOGY

Dr. N. Praveen Kumar

Assistant Professor
School of Life Sciences
Department of Botany
St Joseph’s University
Bengaluru
 INTRODUCTION
• Biology+Technology

• Involves the exploitation of biological agents or

their components for generating useful
products/services
• The use of living microorganisms in systems or
processes for the manufacture of the useful
products , it may be algae, fungi, yeast
bacteria ,viruses , cells of higher plants and animals
or their subsystems or isolated components from
living matter
• It consists of scaling up of biological processes
 Definition
• Biotechnology is defined as the ‘application of scientific and
engineering principles to the processing of material by biological
agents to provide goods and services’.
• The Spinks Report (1980) defined biotechnology as ‘the
application of biological organisms, systems or processes to the
manufacturing and service industries’.
• United States Congress’s Office of Technology Assessment
defined biotechnology as ‘any technique that used living
organisms to make or modify a product, to improve plants or
animals or to develop microorganisms for specific uses’.
• The American Chemical Society defines biotechnology as the
application of biological organisms, systems, or processes by
various industries to learning about the science of life and the
improvement of the value of materials and organisms such as
pharmaceuticals, crops, and livestock
• European Federation of Biotechnology,
biotechnology is the integration of natural
science and organisms, cells, parts thereof, and
molecular analogues for products and services.
• Cohen& Boyer (2016), defined biotechnology as
a technique of using either live organisms or its
constituent enzymes to produce products that
are useful to human.
• Gibbs and Greenhalgh (1983),defined
Biotechnology is the utilization of bacteria,
algae, fungi, multicellular organisms or their
isolated components for the production of
valuable products.
 History
• The term ‘biotechnology’ was first coined by a Hungarian engineer Karl
Ereky in 1919
• 1822-1895 Louis Pasteur, "The father of Microbiology and father of
Industrial Biotechnology'‘ discovered that yeast produced alcohol in
wine and rod-shaped bacteria produced acetic acid, cause souring of
wine.
• The history of biotechnology begins with zymotechnology, which
commenced with a focus on brewing techniques for beer.
• By World War I, however, zymotechnology would expand to tackle
larger industrial issues, and the potential of industrial fermentation
gave rise to biotechnology.
• The oldest biotechnological processes are found in microbial
fermentations, as born out by a Babylonian tablet circa 6000 B.C.
unearthed in 1881 and explaining the preparation of beer.
• 2500 B.C., Aryans started preparing curd.
• 2000 B.C., Greeks were probably first to prepare cheese from milk
• In about 4000 B.C. leavened bread was
produced with the aid of yeast.
• The Sumerians were able to brew as many as
twenty types of beer in the third millennium
B.C.
• In the 14th century, first vinegar manufacturing
industry was established in France near Orleans.
• In 1680 Antony Van Leeuwenhoek first observed
yeast cells with his newly designed microscope.
• In 1857, Louis Pasteur highlighted the lactic acid
fermentation by microbe.
• By the end of 19th century large number of
industries and group of scientists were involved in
the field of biotechnology and developed large scale
sewage purification system employing microbes
were established is Germany and France.
• In 1914 to 1916, Delbruck, Heyduck and
Hennerberg discovered the large-scale use of yeast
in food industry.
• In the same period, acetone, butanol and glycerin
were obtained from bacteria.
• In 1920, Alexander Fleming discovered penicillin
and large scale manufacturing of penicillin started
in 1944.
 Development
• What Are the Stages of Biotechnology
Development
• Ancient biotechnology- early history as related
to food and shelter; Includes domestication
• Classical biotechnology- built on ancient
biotechnology; Fermentation promoted food
production, and medicine
• Modern biotechnology- manipulates genetic
information in organism; Genetic Engineering Or
Synthetic Biology
• 2008 Venter replicated a bacterium’s genetic structure completely from
laboratory chemicals, taking a step nearer to generating the world’s first living
artificial organism .
• 2008 Japanese chemists developed the first DNA molecule made nearly entirely
of artificial parts. The finding could be used in areas of gene therapy
• 2009 Former US President Barack Obama signed an administrative order
releasing national funding for broader research on embryonic stem cells.
Scientists identified three new genes connected with Alzheimer’s disease, paving
the way for possible new diagnostics and therapeutics. Geron commenced the
first FDA approved clinical trial by means of embryonic stem cells.
• 2010 The FDA sanctioned a modified prostate cancer medicine that improves a
patient’s immune cells to distinguish and attack cancer cells. The FDA sanctioned
an osteoporosis treatment that was one of the first medicines based on genomic
investigations. Craig Venter showed that a synthetic genome could duplicate
alone.
• 2011 A trachea developed from stem cells was transplanted into a human
recipient. Progress in 3D printing technology resulted in ‘skin-printing’. The FDA
sanctioned the first cord blood therapy to be employed in hematopoietic stem
cell transplantation protocols in patients with disorders influencing the
hematopoietic system.
• 2012 The FDA issued draft regulations for biosimilar drugs
 Scope
• 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, Geneatech, Hybritech, etc.
• In world, USA, Japan, and many countries of Europe are leaders in
• These companies are working for human welfare and opted following areas for
research and development:
• (a) Automated bio-screening for therapeutic agents.
• (b) Bio-processing alkenes to valuable oxides and glycols.
• (c) Developing immobilized cell and enzyme systems for chemical process industries.
• (d) Engineering of a series of organisms for specific industrial use.
• (e) Genetical improvement of microorganisms for production of pharmaceutical
products.
• (f) Human gene therapy.
• (g) Improved production of Vitamin B12.
• (h) Large-scale production of fructose from inexpensive forms of glucose.
• (i) Manufacturing ethanol by continuous fermentation.
• (j) Microbiological based production of human insulin and interferon’s.
• (k) Microbiologically up-gradation of hydrocarbons.
• (l) Production and development of vaccine to prevent calibacillosis.
• (m) Production of bio-pesticide and bio-fertilizers.
• (n) Production of diagnostic kits for toxoplasmosis identification.
• (o) Production of monoclonal antibodies for organ transplant tissue typing.
• (p) Production of photo-synthetically efficient plants.
• (q) Production of transgenic plants and animals.
• (r) Production of xanthan gum in oil fields for recovery of crude mineral oils.
• 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.
 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%
• 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.
• Biopharmaceutical Drug Development:
• In the field of biopharmaceutical development, it is the
development of therapeutic human proteins by
recombinant methods. 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.
• 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.
• 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 agroindustry.
• 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.
• 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.