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

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

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

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

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.

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)

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

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.

History of Biotechnology: Understanding Fermentation Anton Van Leeuwenhoek (1632-1723) Discovered microorganisms using his microscope (Gave clue to fermentation) Louis Pasteur (1822-1895) Reported different types of Fermentation (Gas, Acid and Alcohol) Eduard Buchner (1860-1917) Developed concept of enzyme

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.

History of Biotechnology Modern Biotechnology 1953- Discovery of DNA! 1973- Walter Gilbert carried out 1st recombinant DNA experiments 1975- 1st hybridomas were created 1982- Production of st Monoclonal Antibodies 1982- first recombinant human therapeutic protein- Insulin! 1976- 1st Biotech Company- Genetech (U.S.)

History of Biotechnology: Modern Biotechnology

Why do we need Biotechnology?

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

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

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

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

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.

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

Dimensions of Biotechnology

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

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

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.

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.

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

Pharmaceutical Biotechnology Research and Development

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.