Biotechnology free sessionff

BIOTECHNOLOGY AND ITS APPLICATIONS
DR. HASSAN MOSTAFA, REYADAPRO EXPERTS FOUNDER & GM
DR. HASSAN MOSTAFA, REYADAPRO EXPERTS FOUNDER & GM 1

Introduction
• Biotechnology is the broad area of biology, involving:
• living systems and organisms to develop or make products, "any
technological application that uses biological systems, living organisms,
or derivatives thereof, to make or modify products or processes for
specific use“.
• Depending on the tools and applications, it often overlaps with the
(related) fields of molecular biology, bio-engineering, biomedical
engineering, biomanufacturing, molecular engineering, etc.

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Introduction
• "biotech" or "biotechnology" encompasses a wide range of procedures for
modifying living organisms according to human purposes, going
"improvements" to these through breeding programs that employ artificial
back to domestication of animals, cultivation of the plants, and
"improvements" to these through breeding programs that employ artificial
selection and hybridization.
• Biotechnology is branch of science in which living things are used to make new
products; via using of living organisms or processes to make products useful for
mankind.

What is Biotechnology?
➢ Biotechnology = Biology + Technology
➢ Understanding & Manipulation of Genes (The code of life) and Their
Products for Useful Purposes
Technology based on biological sciences that includes
➢ Agriculture
➢ Food science
➢ Genetics
➢ Medicine

❖ European Federation of Biotechnology (EFB) has defined biotechnology
as “The integration of natural science and organisms, cells, parts thereof,
and molecular analogues for products and services”.
Introduction
❖ Modern usage also includes genetic engineering as well as cell and tissue
culture technologies.

HISTORY
▪ Has been existing since centuries Begin with the first action of human on life
for his welfare It started when people modified microorganisms to the needs of
humanity.
▪ In past biotechnologists used yeast cells to ferment alcoholic drinks and the
bacteria to make cheese and yoghurt.
▪ Term coined by a Hungarian engineer Karl Ereky Modern biotechnology started
in California in 1970’s
▪ Before 1971, the term biotechnology was used primarily in food processing
and agriculture industries.

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Oldest form of biotechnology
Making breads and curds with the help of micro organisms

Application of fermentation in production of
wine and other alcoholic beverages is also
a biotechnological technique
Oldest form of biotechnology

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• 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
What Are the Stages of Biotechnology
Development

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• Genetic Engineering
• Protein engineering
• Bioinformatics
• Immunology
• Plant biotechnology
• Animal biotechnology
Areas of Biotechnology
• Cancer biology
• Environmental Biotechnology
• Marine Biotechnology
• Nano biotechnology
• Pharmacology

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A multidisciplinary field involving number of interrelated subjects
❑ SCIENCE
❑ Physical sciences
❑ Life sciences
❑ Social sciences
❑ MATHEMATICS
❑ Statistics
❑ APPLIED SCIENCES
❑ Computer applications
❑ Agriculture
❑ Instrumentation
APPLICATIONS

Its Applications

Application of
Biotechnology in
Food,
Pharmaceuticals
and Agriculture
Industries.

Two important technique :
1. Alteration of chemistry of DNA & RNA to introduce into host organism to
change phenotype of host- Genetic engineering
2. Maintenance of sterile ambience to enable growth of desired microbe/
eukaryotic cell in large quantities for manufacture of biotechnological products
like vaccine, enzymes, beverages, drugs etc.- Chemical engineering
Development Of Modern Biotechnology:

• Medical
➢ Understand life processes in healthy and disease states
➢ Genetic diseases
• Biotech and Pharmaceutical
➢ To find or develop new and better drug
➢ Designing drug (Gene or Structure based)
• Agriculture
➢ Disease, drought, heat resistant plants
➢ High yielding crops
Applications

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Its Applications
Biotechnology has applications
in four major industrial areas:
1. Food Industry
2. Health and Medicine
3. Agriculture
4. Industrial & Environmental
Percentage of Biotechnology in firms by application

Fields of Bioscience Technology
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Areas of Biotechnology
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Definition
• Biotechnology is the integration of
natural science and organisms,
cells, parts thereof and molecular
analogues for products and services.
Biotechnology Process & application
19

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Animal
cloning
Gene cloning for
pharmaceutical production
Genetically modified
foods and the
American-European
opinion divide.
DNA
fingerprinting
The promise and perhaps
perils of embryonic stem cells
Examples

A wide range of
fermented food and
drink

Application of Biotechnology in Food Industry
Food biotechnology :
• Modify genes of animals, plants, and
microorganisms to create new species which have
desired production, marketing, or nutrition related
properties.
• Include a wide range of diverse technologies and
they may be applied in each of the different food and
agriculture sectors.

• Food fermentations, food additives and processing aids,
food safety through advances in microbial genetics,
detection of pathogens, mycotoxin detection and
identification of foods and food ingredients.
• Targets the selection and improvement of
microorganisms with the objectives of improving process
control , yields and efficiency as well as the quality,
safety and consistency of bioprocessed products.
Application of Biotechnology in Food Industry

❑ A major problem in fruit marketing is premature ripening and softening
during transport.
❑ These changes are part of the natural ageing ( senescence) process
of the fruit.
❑ Ripening of fruit is closely associated with increase in
polygalaturanase activity.
Extended shelf life of fruit

▪ Genetically modified crops and plants
▪ Transgenic plants
▪ Plant tissue culture
▪ Therapeutic plants
▪ Molecular pharming
Engineering plants genetically is Plant Biotechnology
Plant Biotechnology

Biotechnology Goals in Medicine
➢To identify and manage the root cause of diseases.
➢To find ways to improve lives through better health.
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Medical Biotechnology
➢ Production of Drugs and Therapeutics
➢ Genetically modified organisms
➢ Analysis of the Genes in genetic disease
➢ Correction of genetic defects

Molecular Medicine
in the Era of Biotechnology
• Improved diagnosis of disease
•Earlier detection of genetic
predispositions to disease
• Rational drug design
• Gene therapy and control systems for
drugs
• Pharmacogenomics "custom drugs"
➢ To identify and manage the root cause
of diseases.
➢ To find ways to improve lives
through better health.

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Biotechnology in medicines:
❖Diagnose & treat different diseases with effective recombinant therapeutic
drugs.
❖Protect from dangerous diseases Through gene therapy new & healthy
genes can be inserted to replace damaged cells Targeted action of drug
by thorough study of genomics.
❖Recombinant therapeutics do not induce unwanted immunological
responses as in case of similar products isolated from non- human source.
.
Biotechnological applications in Medicine

Medicine and Health Care
❑ The medical application of biotechnology is often referred to as Red
Biotechnology.
❑ Health care biotechnology uses chemistry of living organisms through
molecular biology and cell manipulation to develop new or alternative
methods in order to find more effective ways of producing traditional Its
integration with nanotechnology, Nano-materials and information
technology has led to the development of innovative and revolutionary
applications in health care.

Medicine and Health Care
❑ Nowadays health care Biotech products and techniques are being
implemented in various areas of health care, including:
❑ biopharmaceuticals,
❑ drug delivery systems,
❑ diagnostic testing,
❑ tissue replacement,
❑ etc.

Introduction to Vaccines
➢ The modern biotechnological tools and genomics have opened a new era to
develop novel vaccines and many products are successfully marketing
around the world.
➢ New vaccines employing biotechnological innovations are helping us to
change the way for illness prevention.
➢ The clinical application of vaccines will be diversified along with the
development of biotechnologies.

✓ A biological preparation, which evokes an immune response when
administered into the body, is termed as vaccines.
✓ Consists of parts of pathogen in its weakened state or its products.
✓ This triggers an immune response from the body to the particular disease
without actually causing the disease.
✓ This method has helped create more than 20 new vaccines against
infectious agents, improved existing vaccines, and increased the amount
of vaccine that can be produced.

✓ Vaccines are preparation, containing weakened or dead microbes of the kind that
cause disease, administered to stimulate the immune system to produce
antibodies against the disease.
✓ Vaccine was used by British Physician Edward Jenner at the end of 18th century
in the terms “vaccine disease” means at that time the Sore of other disease is
inoculated to immunize the person.

1. High cost of production.
2. Have to be stored at low temperature since heat destabilizes protein.
Hence storage and transportation is tedious.
3. Individuals with immunodeficiency may elicit poor immune response.
Vaccines Risks involved

I- Generation of the antigen
1. Generating the antigen that will trigger the immune response. For this purpose the
pathogen’s proteins or DNA need to be grown and harvested using the following
mechanisms:
• Viruses are grown on primary cells such as:
• cells from chicken embryos or
• using fertilised eggs (e.g. influenza vaccine) or
• cell lines that reproduce repeatedly (e.g. hepatitis A)
Steps of Production of New Vaccine

• Bacteria are grown in bioreactors which are devices that use a particular growth
medium that optimizes the production of the antigens
• Recombinant proteins derived from the pathogen can be generated either in yeast,
bacteria or cell cultures.
• Release and isolation of the antigen The aim of this second step is to release as
much virus or bacteria as possible.
• To achieve this, the antigen will be separated from the cells and isolated from the
proteins and other parts of the growth medium that are still present.

Purification
➢ The antigen will need to be purified to produce a high purity/quality product.
➢ Using different techniques for protein purification.
➢ Several separation steps will be carried out using the differences in for instance
protein size, physio-chemical properties, binding affinity or biological activity

Addition of other components
➢ The fourth step may include the addition of an adjuvant, which is a material that
enhances the recipient’s immune response to a supplied antigen.
➢ The vaccine is then formulated by adding stabilizers to prolong the storage life or
preservatives to allow multidose vials to be used safely as needed.
➢ Due to potential incompatibilities and interactions between antigens and other
ingredients, combination vaccines will be more challenging to develop.
➢ Finally, all components that constitute the final vaccine are combined and mixed
uniformly in a single vial or syringe.

Packaging
❑ Once the vaccine is put in recipient vessel (either a vial or a syringe), it is sealed
with sterile stoppers.
❑ All the processes described above will have to comply with the standards defined
for Good Manufacturing Practices that will involve several quality controls and an
adequate infrastructure and separation of activities to avoid cross contamination, as
shown in the diagram below.
❑ Finally, the vaccine is labelled and distributed worldwide.

o According to the Vaccination point of view the various species cause different
diseases such as HIV (Human immune deficiency Virus), Influenza virus which
causes the Cold, Hepatitis-C are not vaccinated because there is no vaccine for
these diseases.
o Researchers have made so many struggles to produce a vaccine for these type of
diseases but they have to face the restrictions i.e. about 200 species of influenza
virus have been detected.
o So how many types of vaccines will be prepared for the influenza virus
Restriction for the discovery of New Vaccines

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o Different vaccines are produced in different periods of time and estimated time for
the production is given by the researchers.
o It had taken 105 years after the discovery of the typhoid bacterium to develop
a vaccine for typhoid.
o For whooping cough (pertussis) it had taken 89 years; for polio and measles 47 and
42 years respectively.
o But the time lag was getting shorter.
o It had only taken 16 years from the discovery of the hepatitis B virus to the
development of a vaccine

o The biotechnology era has experienced significant changes in the number of
companies involved in vaccine manufacturing as well as in the production
systems they use. Nevertheless, challenges in this area are multiple. In the
current vaccine-manufacturing environment, time to market and cost
effectiveness are key issues that need to be addressed.
o One important difference between the production of vaccines and other
biopharmaceuticals is the risk-safety consideration related to working with
pathogens and pathogenic antigens.

Advantages of Vaccines
Advantages of vaccines produced by biotechnology :
➢ Low risk for infection: or protein) are used for making vaccines.
➢ Recombinant vaccines do not contain actual pathogens; only parts of the
microbes (DNA, RNA, conventional vaccines and can be given to people with
weakened immune systems.

Biotechnology basic steps involved in the process

Nano-Technology:
❖ is one of the emerging interdisciplinary fields ..bring a technological
revolution.
❖ Engineering at the atomic or molecular scale, deals with devices typically
less than 100 nanometres in size, or one billionth of a meter, or one ten-
thousandth the width of a human hair
Nano biotechnology

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Nano-Technology:
❖ Provides a new basis for innovation in the life sciences, revolutionary
biotechnology processes, the synthesis of new drugs and their targeted
delivery, regenerative medicine, neuromorphic engineering stem, cell
research, genomics, proteomics as well as the well established fields of
agriculture, environmental management, medical device manufacturing
Nano biotechnology

✓ Specialized nanomachine designed to perform a
specific task or tasks repeatedly and with precision.
✓ Have dimensions on the order of Nanometres.
✓ Developed to kill the cancer cells would have a small
computer, several binding sites to determine the
concentration of specific molecules, and a supply of
some toxin, which could be selectively released to kill
a cell identified as cancerous [malignant].
Nanobots

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Nanobots

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❖ Nano bomb
❖ Nanoimaging
❖ Nano drug delivery
❖ Microbivore
❖ Artificial mechanical phagocytes
❖ Tissue reconstruction
❖ Frying tumors
❖ Quantum dots
Nanobots Applications

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➢ Using scientific methods with organisms to
produce new products or new forms of
organisms.
➢ Techniques used to produce or modify plants
and animals or its substances and utilize
microorganisms for specific use.
Bioengineering

• The study of science in which biology, computer science and information
technology merge into single field.
• Managing and analyzing biological data using advanced computing
techniques
• Major research efforts in the field include sequence alignment, finding
gene, genome assembly, protein structure alignment, protein structure
prediction, prediction of gene expression and protein-protein interactions,
and the modelling of evolution
Bioinformatics

❖ Bioinformatics is the computer assisted data management field that
helps us
➢ Gather
➢ Store
➢ Analyze
➢ Integrate
biological and genetic information ( data )
❖ Bioinformatics is the “Electronic Infrastructure of Molecular”
Computers and Bioinformatics

❖ There are many different Bioinformatics tools available online that
contains biological databases. Commercial software are also used
by researchers
❖ It is associated with massive databases of gene and protein
sequences and structure/function information databases
❖ New sequences, new structure, protein or gene function that are
discovered, searched, gathered and deposited into databases

What is done ?
• Analysis and Interpretation
• Development of new Algorithm and Statistics
• Development and Implementation of tools

Application of Biotechnology
in
Pharmaceutical Industry

➢ Science which combines biology with technology .
➢ Manufacturing of vaccinations and genetic testing.
➢ Manufacturing of vaccines:
➢ To help tackle severe health problems and benefit the
society in a major way.
Due : population increasing percent; changing lifestyles
and economies lead to facing health problems and
diseases that are tough to cure.
Application of Biotechnology in Pharmaceutical Industry

➢ Successfully found cure for numerous diseases
including cardiovascular disorders, arthritis, Hepatitis
B, bone fractures etc.
➢ By investing, Pharma manufacturers find solutions to
diseases were considered to be incurable.
Application of Biotechnology in Pharmaceutical Industry

Insulin: Important hormone regulating glucose levels.
Anti-haemophilic Factor: Purified from human blood,
used in the treatment of haemophilia. Action has proved
difficult because of infection of haemophiliacs with AIDS
virus.
Gene therapy: using of DNA as a pharmaceutical agent to
treat disease.
➢ Derives its name from the idea that DNA can be used to
supplement or alter genes within an individual's cells as a
therapy to treat disease
➢ The most common form of gene therapy involves using
DNA that encodes a functional, therapeutic gene to replace
a mutated gene.
Examples

Human Serum Albumin:
➢ Most common blood proteins used in the treatment
of shock injuries such as burns.
Engineered Enzymes:
➢ Treat a range of conditions from cardiac diseases to renal
failure, to certain types of inherited enzyme deficiencies.
➢ Rapid advances in the field, and new horizons include the
development of enzymes like biosensors or bio electrodes to
monitor many physiological processes.
Examples

➢ Blood Proteins: Erythropoietin, Factors VII, VIII, IX;
Tissue plasminogen activator; Urokinase.
➢ Human Hormones: Epidermal growth factor; Follicle
stimulating hormone, Insulin.
➢ Immune Modulators: α Interferon, β Interferon;
Colony stimulating hormone; Lysozyme; Tumor
Necrosis factor.
➢ Vaccines: Cytomegalovirus; Hepatitis B; Measles;
Rabies
Some examples of
therapeutic products
made by
recombinant DNA
techniques

▪ Microorganisms can be used to make biological substances for humans which are
equally effective as natural substances
▪ Microorganisms such as bacteria and yeast are used to make substances (produce
drugs) like insulin and interferon
▪ Treatment of diseases like hepatitis and arthritis are made possible with the help of
biotechnology
DEVELOPMENT OF MEDICINE

❑ Deficiency of Insulin causes Diabetes which can be controlled by taking
insulin at regular intervals Traditionally when human- insulin were not
available, insulin of animals (slaughtered cattle & pigs)
❑ Animal insulin- trigger some immune response like allergy and some reaction
due to foreign insulin & will not be effective Bacteria were genetically
engineered- produce human insulin in large quantities as bacteria can easily
grown in culture medium
Genetically Engineered Insulin

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DRUG PRODUCTION
INSULIN:
▪ Human insulin is being produced using genetic engineering
technique known as Humulin and it is used for the treatment of
diabetes that is low sugar level in the blood…..
INTERFERON:
▪ Interferon interfere in transmission of viral genome from one cell to another and
it also inhibits the cell division of abnormal cells.
▪ Interferon produced using the recombinant DNA technology is used to treat
cancer patients.
▪ Interferon improved the quality of life of cancer patients…..

TYPES OF BIOTECHNOLOGY
Green biotechnology (agricultural applications)
Red biotechnology (medical applications)
Blue biotechnology (aquatic applications)
White biotechnology (industrial applications)

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➢ Vitamin A deficiency is a serious
problem and can cause blindness at a
young age if left untreated
➢ Golden rice was genetically modified to
produce beta-carotene (a precursor of
vitamin A that the body converts to
vitamin A).
➢ A diet including golden rice can help to
raise vitamin A levels
GREEN BIOTECHNOLOGY

WHITE BIOTECHNOLOGY
➢ Called industrial biotechnology.
➢ It is the designing of an
organism to produce useful
chemicals i.e. enzymes.

❖ The use of biological methods to optimize industrial processes
❖ Applied by manufacturers of laundry detergents Includes research for
new enzymes (proteins that remove oily and protein-based stains)
❖ Enzymes that work under extreme conditions (wash temperatures of
20°C or 90°C)
❖ This often entails modifying the enzymes of microorganisms for these
processes
WHITE BIOTECHNOLOGY

RED BIOTECHNOLOGY
➢ Used in medical processes.
➢ Involves the manipulation of microorganisms to
make products such as antibiotics.
Includes:
o Production of medicines and
pharmaceutical
products for treating or diagnosing
disorders
o Designing of organisms to manufacture
antibiotics and vaccines
o Engineering of genetic defects through
genomic manipulation
o Use in forensics through DNA
profiling
Examples:
➢ Production of human insulin from non-
human sources.
➢ Production of hormones like Interferons,
Cytokinin's, Steroids and human growth
hormones.
➢ Gene therapy for prevention and control
of diseases like haemophilia cystic
fibrosis
➢ Development of vaccines and antibodies
for rabies, HIV, etc.

AGRICULTURAL DEVELOPMENT
DNA of plant is modified to:
▪ Enhance protection of plants against diseases
▪ Increase the quality and nutritional value of the plants
▪ Increase the yield of the plants

ENVIRONMENT
Biotechnology helps to:
➢ Eliminate pollutants
➢ Removes wastes from environment

Ethical argument for or against the following topics
❑ Human Cloning
❑ Gender Reversal on Livestock
❑ Gender Reversal on Humans
❑ Genetic Engineering of Plants
❑ Genetic Engineering of Humans
Biotechnology Ethical Arguments

➢ New and innovative industry with innumerable career options
for anyone interested in life sciences.
➢ Biotechnology has changed the quality of life through improved
medicine, diagnostics, agriculture and waste management
Biotechnology Career opportunities

• Research
• Quality control
• Manufacturing and production
• Regulatory affairs
• Administration
• Information system
• Clinical research
• Marketing and sales
Biotechnology Occupational opportunities

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• Genetically engineered microbes used for producing drugs and vaccines
in large scale at low costs that are of great importance (human insulin,
erythropoietin, and hepatitis-B vaccine)
• Genetically engineering plants are also poised to produce vaccines
• One of the future sources of cheap protein drugs in the coming years,
would be genetically engineered animals who would secrete drugs in
abundance.
Scope of biotechnology

Biotechnology gives answer to:
• Food scarcity,
• Ecological problems ,
• Pharmaceutical sector drop
Future belongs to Biotechnology

In simple words, Biotechnology play a major role in the production of new
vaccines, which will be Tested, Measured, cheaper and Nanotechnology based
Vaccines. The Multiple vaccines of Tetanus, Typhoid, Hepatitis and Tuberculosis.
Vaccinology has been very effective in preventing infectious diseases. However,
in several cases, the conventional approach to identify protective antigens, based
on biochemical, immunological and microbiological methods, has failed to
deliver successful vaccine
Conclusion

Biotechnology Manufacturing Issues
▪ Adverse drug events- ADE
▪ API specifications
▪ Best practices (GCP, GLP, GMP, Clinical trials
▪ FDA regulatory compliance
▪ Microbiology
▪ Batch records
▪ Process validation
▪ TQM/QA/QC; …etc

Adverse Drug Event

Quality System

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Quality
requirements/roadmap
of regulatory based on
QbD

Quality Documentation System

The quality target product
profile (QTPP)
A Target Product
Profile (TPP)
Process Development Life Cycle
Quality by Design (QbD)
Certificate of Analysis
(COA)

QM, QA, QC interrelationships

Process Validation

Quality Management System

Records Management- batch record – The Key to Success

Records Management – The Key to Success

Microbiology

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Regulatory Compliance

Best Practices
(Clinical Trials)

Best
Practices
(GCP,
GLP,
GMP)
GCP, GLP & GMP

Plant Design

Pharma., Healthcare & Quality Experts
www.reyadapro-experts.com , Info@reyadapro-experts.com

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