1. Pharmaceutical Biotechnology PHR 403
Course Instructor:
Mir Ishruna Muniyat
Lecturer
Department of Pharmacy
BRAC University

2. Overview of the course (PHR 403)
Introduction to Biotechnology and its application
Classical Biotechnology: Fermentation and its application on Pharmaceutical manufacturing.
Enzyme technology and its application in Pharmaceutical manufacturing
Immunology: Basics, vaccine design, Monoclonal antibodies
Recombinant DNA technologies (rDNA) and production of Biotechn compounds
Formulation of biotech products
Gene therapy
Pharmaceutical production of different Biotechnology products

3. Chapter 1: Introduction to biotechnology and its application
Chapter overview:
Definition of Biotechnology
History of Biotechnology
Application of biotechnology
Pharmaceutical biotechnology

4. Biotechnology As a Science- only about 200 years old
As a technology- Well, very old!
Examples found in: The Indus Valley Civilisation (IVC) or Bronze Age civilisation (3300–1300 BCE)
-fermented food
-Beverages
-Medicines

5. BIOTECHNOLOGY: Definitions
The term “Biotechnology”- by Hungarian engineer, Karl Erky in 1917
-to describe a process for large scale production of pigs
Before the 20th century: making dairy products such as cheese and curd, as well asbread, wine, beer, etc.
Simple Definition- Application of technology using the living organisms to obtain useful products.

6. BIOTECHNOLOGY: Definitions Continued…
Available Definitions :
Biotechnology is the application of biological organisms systems or process to manufacturing and service industries (British biotechnologists)
Biotechnology is integrated use of biochemistry, microbiology and engineering sciences in order to achieve technological applications of microbes, cultured cells and parts there of (European federation of biotechnologist)
Biotechnology is the controlled use of biological agents, such as microbes or cellular components. (U.S.National science foundation)

7. History of Biotechnology: Pre-historic Biotechnology
Ancient Egyptians (Evidence found up to 4000 BC)
Used Yeast to brew wine and make breads.
The Egyptian art of mummification used the technique of dehydration using a mixture of salts.
People of Indus Valley (Mohenjo-Daro and Harappa)
prepared and used various types of fermented foods, beverages, and medicines
Greek civilization
Used crop rotation techniques to exploit bacteria living in the soil to increase crop yield
Mesopotamian civilization
Used bacteria to convert wine into vinegar

8. History of Biotechnology
Use of genetic resources:
The ancient people were also aware of the role of natural genetic resources such as plants in the economic growth of a land.
used to send plant-collectors to gather prized exotic species of plants that produced valuable spices and medicines.
Innstalled Botanic Gardens- These early ‘gene banks’ helped the colonial powers to establish agricultural monocultures around the globe.

9. History of Biotechnology: Understanding Fermentation
Anton Van Leeuwenhoek
( )
Discovered microorganisms using his microscope
(Gave clue to fermentation)
Louis Pasteur
( )
Reported different types of Fermentation (Gas, Acid and Alcohol)
Eduard Buchner
( )
Developed concept of enzyme

10. History of Biotechnology Biotechnology and warfare:
Biotechnology played an important role during World War I
Fermentation techniques were used to produce Glycerine which was a component of explosive nitroglycerine
Scientists used bacteria that converts corn or molasses into acetone for making the explosive cordite
Penicillin, the first antibiotic, proved highly successful in treating wounded soldiers.

11. History of Biotechnology Modern Biotechnology
1953- Discovery of DNA!
1973- Walter Gilbert carried out 1st recombinant DNA experiments
st hybridomas were created
Production of st Monoclonal Antibodies
1982- first recombinant human therapeutic protein- Insulin!
st Biotech Company- Genetech (U.S.)

12. History of Biotechnology: Modern Biotechnology

13. Why do we need Biotechnology?

14. Application of Biotechnology
Biotechnology Color codes-
Color code
Name
Field
Red Biotechnology
Medical Biotechnology
Green Biotechnology
Agriculture Biotechnology
White Biotechnology
Industrial Biotechnology
Grey Biotechnology
Environmental Biotechnology
Blue Biotechnology
Marine Biotechnology

15. Application of Biotechnology
In medicine: (RED biotechnology)
Monoclonal Antibodies
Bioprocessing (Production of medicinally important proteins and vaccines etc.)**
Stem Cell Technology
Tissue Engineering
** Often Industrial biotechnology is called WHITE biotechnology)
In medicine:
Monoclonal Antibodies
Bioprocessing (Production of medicinally important proteins and vaccines etc.)
Stem Cell Technology
Tissue Engineering

16. Application of Biotechnology
There are many application of Biotechnology in Food and agriculture (GREEN biotechnology)
Conventional plant breeding
Tissue culture and micropropagation
Molecular breeding or marker assisted selection
Genetic engineering and GM crops
Plant disease diagnostics
Microbial fermentation
In Food and agriculture
Conventional plant breeding
Tissue culture and micropropagation
Molecular breeding or marker assisted selection
Genetic engineering and GM crops
Plant disease diagnostics
Microbial fermentation

17. Application of Biotechnology
In forensic science (RED Biotechnology)-
DNA Finger printing
Parental identification tests (DNA Paternity testing)
Forensic toxicology

18. Application of Biotechnology
In Environment: (GREY biotechnology)
Biodiversity maintenance
Genetic analysis of the species present in ecosystem
Cloning to preserve endangered species
Contamination removal
Using mutant microorganism to remove waste materials.
Using bi-products to solve different environmental issues.

19. Application of Biotechnology
In Plant genetics
Transgenic plants to increase crop yield, resistance against infectious disease.
Bio-fuel plants (Biomass)

20. Dimensions of Biotechnology

21. Pharmaceutical Biotechnology
Biotechnology: Techniques using living organisms
Production o/ Modification of products.
Researches in cell biology, genetics and recombinant DNA technology
Biotechnology products: Biopharmaceutical drugs

22. Pharmaceutical Biotechnology Continued…
For Example-
Recombinant DNA (rDNA) and monoclonal antibody (MAb)
Development of new pharmaceuticals/
Drug Delivery System

23. Pharmaceutical Biotechnology
Biotechnology encompasses any technique that uses living organisms in the production or modification of products.
Thus, biotechnology products broadly refer to biopharmaceutical drugs generated through researches in cell biology, genetics and recombinant DNA technology.
Recombinant DNA (rDNA) and monoclonal antibody (MAb) are providing exciting opportunities for new pharmaceuticals development as well as new approaches to drug delivery.

24. Pharmaceutical Biotechnology in 20th Century…
Last Decade Development of >359 biotechnology products
(by >40 pharmaceutical companies)
For indications ranging from hemophilia, sepsis, skin ulcers, and rheumatoid arthritis
to cancer.
>One-third of all biotechnology products are geared toward cancer therapy
>29 were under development for HIV, AIDS and AIDS-related diseases.
About 19 other products were being developed for autoimmune diseases.

25. Pharmaceutical Biotechnology in 20th century
During the last decade, over 359 biotechnology products were developed by more than 40 pharmaceutical companies for indications ranging from hemophilia, sepsis, skin ulcers, and rheumatoid arthritis to cancer.
More than one-third of all biotechnology products are geared toward cancer therapy
More than 29 were under development for HIV, AIDS and AIDS-related diseases.
About 19 other products were being developed for autoimmune diseases

26. Pharmaceutical Biotechnology Research and Development

27. Application of Biotechnology in Pharmaceutical Sciences
Biotechnology derived drugs are being applied in-
Cancer therapy,
AIDS and
AIDS-related and autoimmune diseases
In diagnostic investigations
As blood substitutes, clotting factors, etc.
**Human insulin (approved in 1982) and Human Growth Factor were the first set of biotechnology products to be applied for human therapy.