Pharmaceutical
Biotechnology
SYLLABUS
1.Unit-I
1.1 Brief Introduction to Biotechnology with
reference to Pharmaceutical Sciences
➢ Introduction and definition:
• Biotechnology = Biology+Technology
• Biotechnology is the technology based on biology, especially when used in microbiology, agriculture,
food science and medicine.
• Biotechnology is defined as any technological application that uses biological systems, living
organism, cells, tissues, explants or derivatives thereof, to make or modify products or processes for
specific use.
• Another definition is “Application of the principles of engineering and biological science to create
new products from raw materials of biological origin”.
• Biotechnology is derived from three Greek words: bios – life; technos – technology and logos –
thinking.
• The term biotechnology was used for the first time by “Karl Erkey”.
• He was described as the “Father of Biotechnology”. He was a Hungarian Agricultural Engineer in
1919. He published the book called Biotechnology of Meat, fat, & Milk production in an agricultural
large- scale farm, he described an agricultural technology based on converting raw materials into more
useful product in order to cause a boom in agricultural production.
➢ Developments of biotechnology:
➢ Ancient biotechnology:
• Domestication of food products, which is named as agriculture.
• Development of methods for food preservation and storage – used cold caves to preserve food for long
term storage.
• Making of cheese and curd.
• Production of bread, vinegar and other fermentation products like alcoholic beverages.
• Cross breeding of animals- produced mule.
➢ Classical biotechnology:
• Laws of inheritance – Transfer of genetic information found in Pisum sativum by Gregor John Mendel
(1822-1884)
• Theory of evolution resulted from a process called natural selection – Charles Darwin (1809-1882)
• Discovery of first antibiotic from Penicillium notatum-Alexander Fleming (1928)
➢ Modern biotechnology:
• Double helix model of DNA was explained- JD Watson and FHC Crick (1953)
• First successful gene therapy was performed on a 4 year old girl suffering from an immune disorder
• The new antibiotic- teixobactin, which prevents drug resistance in bacteria, was developed to treat
many common bacterial infections, such as tuberculosis and septicemia (2015).
➢ Major fields of biotechnology / scope of biotechnology:
• Biotechnology is divided into the following five main branches based on its applications:
• Animal Biotechnology
• Medical biotechnology
• Industrial Biotechnology
• Environmental biotechnology
• Agro- Biotechnology
➢ Animal Biotechnology:
• It deals with animals, and formation of animal hybrids with increased growth rates, enhanced muscle mass,
enhanced resistance to diseases.
• It is based on science of genetic engineering to produce transgenic animals and to perform cloning.
❑ Tansgenics:
• It is the transfer of genes from one organism to another organism.
❑ Cloning:
• It is a process of producing genetically identical individuals of an organism either naturally or artificially and
used to produce multiple copies of mammals.
❑ Apllications:
• Transgenic and cloned animals can be used to produce therapeutic proteins in large quantities in eggs, milk,
blood or urine. The therapeutic proteins that are used to treat human diseases include hormones, antibodies,
vaccines and so on.
• Transgenic cows that produce myelin basic protein (MBP) in milk (5-10 g/L) help to reduce symptoms of
multiple scelerosis.
• Another major application of animal biotechnology is the use of animal organs in humans called gene knock
out technology to inactivate, or “knock out”, a specific gene. This technology creates a possible source of
replacement organs for human.
➢ Medical Biotechnology:
• It is the use of living cell or cell materials to research and produce pharmaceuticals and diagnostic products
that help in treating and preventing human diseases.
❑ Recombinant DNA technology: Used for production of hormones, antibodies, enzymes, proteins etc like
human insulin for the treatment of diabetes, monoclonal antibodies in the treatment of various cancers.
❑ Gene therapy: It is the use of DNA to supplement or alter genes within an individual cell as therapy to treat
disease eg: Hepatitis, inherited liver disease.
❑ Stem cell therapy: Stem cells are biological cells that can differentiate into other types of cells and can divide
to produce more of the same type of stem cells . Sources of stem cells: Blood from umbilical cord, bone
marrow etc. Treatment of multiple myeloma, sickle cell anemia and many other disease.
❑ Tissue engineering:
• It uses combination of cells, engineering and materials methods, and suitable biochemical and
physicochemical factors to improve or replace biological tissues.
• Eg: Lab grown tissue was successfully us=sed to repair knee cartilage, edible artificial animal muscle tissue
cultured invitro.
❑ Biosensors:
• It is an analytical device that converts a biological response into a physical, chemical or electrical signal.
• Eg. Enzymatic biosensor used for monitoring of aeging of beer, glucose biosensors to detect diabetes melitus
➢ Industrial Biotechnology:
• It deals with producing and processing materials, bioenergy, chemicals and also pharmaceutical products.
• Eg: Bioplastics such as starch-based, pharmaceutical industries like rhodanese in cyanide poisoning,
serrapeptase in anti inflammatory activity and so on.
➢ Environmental Biotechnology:
• It is the application of processes for the protection and restoration of the quality of the environment. It can be
used to detect, prevent and remediate the emission of pollutants into the environment in a number of ways.
• Bioremediation, waste water and industrial effluents etc.
➢ Agro-biotechnology:
• It is a combination of tissue culture and genetic engineering. It deals with development of transgenic plants.
• Eg: Genetically modified crops like Golden rice which is rich in vitamin A
➢ Pharmaceutical biotechnology:
• It consists of combination of two branches which are pharmaceutical science and biotechnology. It can be
defined as the science that covers all technologies required for the production, manufacturing and registration
of biological drugs.
➢ Applications of pharmaceutical biotechnology:
❑ Types of biotech based pharmaceuticals:
• Cytokines are hormone like molecules that can control reactions between cells. They activate immune-system
cells such as lymphocytes and macrophages. Eg: interferons, interleukins etc
• Enzymes produced from rDNA technology helps fight diseases. Enzymes such as Alteplase, Imiglucerase etc.
• Hormones such as human insulin.
• Clotting factors such as Abciximab prevents blood clotting and used as an adjunct to angioplasty.
• Vaccines such as hepatitis B vaccine, ebola virus vaccine etc.
• Antisense technology which includes fomivirsen, an FDA approved medication.
• Drug delivery systems: Antibody targeted systems, RBC’s as drug delivery vehicles
• Monoclonal antibodies: Mabs are the products of hybridomas cells that results from the biotech fusion of
bone- marrow tumor cells and B lymphocytes. Hybridomas can be geared to produce specific Mabs
continuously. Eg: Transtuzumab for breast cancer
Thank you
