• Cr ommelin DA. and Sindelar RD 1997, Phar maceut ical Biot echnology, Har wood Acad. Pub.• Glick BR and Past er nak J J , 2000, Molecular Biot echnology: Pr inciples and applicat ions of r ecombinant DNA. ASM Pr ess. W ashingt on, DC.• Har dman, J G et al., 2000, Goodman & Gilman’s The Phar macological basis of t her apeut ics, 10 t h ed. McGr aw-Hill• W alsh G., 1998, Biophar maceut icals: Biochemist r y and biot echnology. J . Wiley & Sons.• Select ed paper s and power point f r om t he int er net
Why should pharmacy students study Pharmaceutical Biotechnology? Main f ocus of new dr ug development Car eer s in biot ech indust r y Car eer s in big phar ma Appr eciat ion and knowledge about t he f ield.
Important Dates in the development of Biotechnology o 1953 Double helical structure of DNA discovered. o 1971 Restriction enzymes discovered. o 1975 Monoclonal antibodies produced. o 1977 First human gene cloned. o 1982 Recombinant human insulin approved by the FDA. o 1990 First human gene therapy trial. o 1997 First mammal cloned from adult cells. o 2000 Sequence of human genome identified. o 2004 First human clone is created.
The application of scientific and engineering principles on processing of material bybiological agents to provide goods and services primarily in pharmaceutical environment
Potential Benefits From Biotechnology• More accurate disease diagnosis and treatment• Improve crop yield, disease and stress resistance• Microbial production of chemicals, enzymes, food additives, pharmaceuticals, polymers, etc.• Livestock with enhanced genetic attributes• Elimination of pollutants and waste materials
Potential Social Concerns and Consequences of Biotechnology• Organisms harmful to other organisms or environment• Organisms reduce natural genetic diversity• Genetic engineering of humans?• Genetic privacy issues• Limited availability to poorer nations• Undermine traditional agricultural practices
Disciplines to contribute Microbiology Biochemistry Genetics Chemical EngineeringMolecular biology Pharmaceutical Biotechnology Drugs Dev Vaccines Mol. Diagnostics Drug Deliv. Syst.
Pharmaceutical Biotechnology Drug delivery system development1. Chemical base: * Chemical modif ication * Liposome1. Immunological base: * Monoclonal Ab- conjugation
Biotech success storiesHuman Insulin (Humulin®) First FDA approved drug produced by rDNA technology. Insulin was extracted from the pancreas of cows and pigs. Amino acid sequence of bovine and swine insulins differed from the human sequence by a few AA.
Biotech success stories Human Insulin (Humulin®) Some diabetics produced antibodies to the animal insulin resulting in serious immune reaction. Humulin® eliminates adverse immune response to animal insulin No longer rely on animal sources for insulin.
Biotech success stories Human growth hormone(HGH) GH (pituitary gland) important regulator of growth during development. Children born with growth hormone deficiency become dwarfs. Regular injections of GH during development restores natural growth.
Biotech success stories Human growth hormone (HGH) Animal-derived GH is ineffective in humans. HGH isolated from the pituitary glands of human cadavers. Increased incidence of Creutzfeldt-Jakob disease in patients received HGH.
Lecture plan1. DNA Recombinant 1. Enzyme involved 2. Vector 3. Restriction endonuclease enzyme 4. Cloning selection2. Expression of Recombinant DNA in prokaryote 1. Manipulation of cloned-gene 2. Vector choices 3. Increase of expression3. Therapeutic proteins 1. Source and problem of therapeutic proteins 2. Production of therapeutic proteins 3. Modification of therapeutic proteins
4. Stem Cell a. purpose b. social impact c. type of therapy