This document provides an overview of biotechnology, including genetically modified organisms (GMOs) and gene therapy. It defines biotechnology as the application of biological processes and organisms to develop useful products. The principles of biotechnology involve genetic engineering techniques like recombinant DNA to alter genes and introduce traits. Applications include GMOs in crops and animals to improve traits, as well as gene therapy to treat genetic disorders. Biotechnology impacts society through advances in healthcare, agriculture, environment, and industry. However, genetic engineering risks include unintended consequences and ethical issues that require careful evaluation and oversight.

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Learning Outcomes and Performance Indicators
1. Define genetically modified organisms and gene therapy.
2. Explain the significance of GMOs, and gene therapy to society.
3. Evaluate the societal and environmental impacts of biotechnological applications.
4. Define gene therapy and its potential applications in treating genetic disorders.
5. Discuss the ethical implications of manipulating genes and genetic material in humans,
animals, and plants.
Topic Outline
1. Biotechnology Defined
2. Principles of Biotechnology
a. Genetic Engineering
b. Chemical Engineering
3. Applications of Biotechnology
a. Genetically Modified Organisms (GMOs)
b. Gene Therapy
4. Impacts of Biotechnology to Society
5. Risks of Genetic engineering
BIOTECHNOLOGY
In the process of biotechnology, enzymes or live organisms
are used from the organisms themselves to result in products that
are useful to humans and used to improve our lives on the planet. A
few techniques like test-tube babies from in vitro fertilisation, gene
synthesising, DNA vaccine development and defective gene
correction are parts of Biotechnology.
In its most basic form, biotechnology refers to the application
of biological principles and processes in technology. By utilizing cellular and biomolecular mechanisms,
biotechnology aims to create innovative technologies and products that enhance our lives and
contribute to the well-being of our planet. Throughout history, we have leveraged the biological
activities of microorganisms for over 6,000 years to produce beneficial food items like bread and
cheese, as well as to extend the shelf life of dairy products.
PRINCIPLES OF BIOTECHNOLOGY
Modern biotechnology is highly dependent on genetic engineering and bioprocess
engineering.
1. Genetic Engineering: Techniques to alter the chemistry of genetic material (DNA and RNA),to
introduce these into host organisms and thus change the phenotype of the host organism.
Biotechnology:
Genetically Modified Organisms and
the Human Gene Therapy
Module 9

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Recombinant DNA technology is the main pillar of genetic engineering. Recombinant DNA
Technology is a technique to alter the genes of an organism. The desired gene is inserted into
host using recombinant DNA technology. The host shows the desired trait phenotypically, which
is governed by the inserted gene host using recombinan, which is
governed by the inserted gene.
Process:
a. Identify section of DNA that contains required gene from
source chromosome
b. Extract required gene
c. Insert required gene into vector/bacterial plasmid
d. Insert plasmid into host cell
e. Grow transformed cells to produce a genetically- modified
organism
2. Chemical Engineering: As a result of biotechnology, the
produced biochemical products have a much higher value. Biotechnology has deep roots of
application in pharmaceuticals, which resulted in the development of qualitative and
quantitative products. Vaccines, enzymes, and antibiotics are the best results of biotechnology
in medications.
APPLICATIONS OF BIOTECHNOLOGY
1. Genetically Modified Organisms (GMOs)
A genetically modified organism (GMO) is
a living organism particularly animal, plant,
microbe whose DNA has been transformed or
changed through genetic engineering
techniques (nationalgeographic.org 2019
GMO crops possess three common
characteristics which are resistance to damage
from Insects, resistance to plant viruses, and
tolerance to herbicides. Most of the GMOs are
made to possess one of these attributes which
are helpful to farmers.
Selective breeding and crossbreeding methods have been used over generations to
create organisms with desired traits. Unfortunately, not all attempts were successful. Some
experiments led to mixed results. Meaning, there are modified organisms with both desired and
unwanted traits. Nowadays, advancement in biotechnology allowed scientists to directly
manipulate the genetic material of microorganisms, crops, and animals producing the desired
outcome.
The key difference between GMO and transgenic organism is that GMO is an organism
that has an artificially altered genome, while the transgenic organism is a GMO that has an
altered genome containing a DNA sequence or gene from a different species
Brief History of GMOs
A. Plants
a. In 1982, the first genetically modified plant was produced which was an antibiotic-
resistant tobacco plant.

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b. In 1994, US approved Flvr Savr tomato for sale in US.
c. In 1995, Bt potato, canola and Bt cotton was
approved.
d. In 1996, the first GM maize producing a Bt Cry protein
was approved.
e. In 2000, the first two GM rice varieties both with
herbicide-resistance, called LLRice60 and LLRice62, were
approved in the US.
f.In 2000, vitamin A enriched golden rice was introduced.
g. In India, Bt cotton was released in 2002.
h. In China, insect-resistant GM rice have been approved for food, feed, and cultivation in
2009.
i. Till 2013, a total of 36 countries have granted regulatory approvals for biotech crops,
involving 27 GM crops and 336 GM events.
B. Animals
a. The first transgenic animal was a supermouse
created by Ralph Brinster and Richard
Palmiter in 1982.
b. The first transgenic primate, created by
researchers at the Oregon Health Sciences
University, was born in October 2000.
c. In 2015, Beijing Genomics Institute
announced the sale of the first micropigs
created with the help of the TALENs gene-editing technique.
d. In 2015, CRISPR/Cas9 modified 60 genes in pig embryos in first step to create organs
suitable for human transplants.
e. In 2021, First genetically engineered pig kidney was successfully transplanted into a
brain-dead human patient.
f. In 2022, the first pig-to-human heart transplant was done.
Pros and Cons of GMOs
PROS
•May have fewer pesticides
•Usually cheaper
•May have more nutrients
•Can help us to increase crop
yields
•Can reduce the global hunger
problem
•Longer shelf-life of genetically
modified food
CONS
•May cause allergic reactions
•May increase antibiotic resistance
•Spread of serious epidemics or
pandemics
•Possible safety issues of GMOs
•GMOs may alter the DNA of
organisms
•Long-term consequences are still
unclear

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2. Gene Therapy
Gene therapy is one of the modern attempts to reduce the negative clinical
consequences of genetic diseases. This emerging
field needs to be explored more by researchers
and medical practitioners to maximize its
enormous potential at eliminating global
pathologic conditions that are not yet curable.
Human gene therapy seeks to modify or
manipulate the expression of a gene or to alter
the biological properties of living cells for
therapeutic use. Gene therapies are potential
therapies that can be applied to cure a wide
range of diseases. The purpose of these medical
applications is not only to reduce the symptoms of diseases but to eliminate the causative agent
of the disease.
IMPACTS OF BIOTECHNOLOGY TO SOCIETY
Biotechnology has had significant impacts on society across various fields. Here are some of the
key impacts of biotechnology:
1. Healthcare and Medicine: Biotechnology has
revolutionized healthcare and medicine. It has led
to the development of advanced diagnostic tools,
genetic testing, and personalized medicine.
Biotechnological advancements have also resulted
in the production of recombinant drugs, such as
insulin, growth hormones, and clotting factors,
improving the treatment of various diseases.
Additionally, gene therapy and stem cell research
hold promise for potential cures for genetic disorders and regenerative medicine.
2. Agriculture and Food Production: Biotechnology has transformed agriculture and food
production. Genetically modified organisms (GMOs) have been engineered to possess
desirable traits such as resistance to pests, diseases, and herbicides, as well as enhanced
nutritional content. This has increased crop yields, reduced dependence on chemical
pesticides, and improved food quality. However, the use of GMOs also raises concerns
regarding environmental impact, biodiversity, and food safety.
3. Environmental Impact: Biotechnology
plays a role in environmental conservation and
sustainability. Bioremediation techniques utilize
microorganisms or enzymes to break down
pollutants, reducing soil and water
contamination. Biotechnology is also being
applied to develop renewable energy
sources, such as biofuels and bioplastics, which
can help reduce dependence on fossil fuels
and mitigate climate change.

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4. Industrial Applications: Biotechnology has influenced various industries. Enzymes produced
through biotechnology are used in various manufacturing processes, including the production
of textiles, detergents, paper, and biofuels. Biotechnology has also contributed to the
development of biodegradable materials, reducing waste and pollution. Additionally, it has
facilitated the discovery and production of novel compounds for pharmaceuticals, cosmetics,
and other consumer goods.
RISKS OF GENETIC ENGINEERING
1. May lead to issues of inequality, discrimination,
and societal divisions
2. Obtaining informed consent from individuals or
affected parties can be complex and raises
concerns about decision-making on behalf of
future generations
3. May have unintended consequences, such as
unforeseen genetic mutations, disruptions in
ecosystems, or unforeseen health risks, which
need to be carefully evaluated and monitored
4. Concerns about the long-term effects and potential risks
5. Concerns about animal welfare and the potential for exploitation or harm to vulnerable
populations
6. Unintended consequences on the environment and disrupting natural balances
7. “Playing God”
8. Tampering with nature by mixing genes among
species
Addressing these ethical issues requires
ongoing dialogue and engagement among scientists,
policymakers, ethicists, religious leaders, and the
public to ensure responsible and ethical use of
genetic engineering technologies while balancing
potential benefits with risks and ethical considerations.