Pharmaceutical biotechnology uses biological systems and organisms to develop pharmaceutical products and medical treatments. It has revolutionized drug discovery, diagnostic development, gene therapy, vaccine production, and drug delivery systems. Some key applications include using recombinant DNA and cell culture techniques to produce therapeutic proteins like human insulin and growth hormone. Overall, pharmaceutical biotechnology is now the main focus of new drug development and has opened up many career opportunities in the biotech industry and large pharmaceutical companies.

1. Pharmaceutical Biotechnology

2. • 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

4. 1. www.freemedicaljournals.com
2. www.biomedcentral.com
3. www.nejm.org
4. www.asm.org
5. http://www.bibalex.org/supercourse/ppt.htm

5. 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.

6. 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.

8. The application of scientific and engineering
principles on processing of material by
biological agents to provide goods and services
primarily in pharmaceutical environment

9. 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

10. 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

11. Disciplines to contribute
Microbiology Biochemistry Genetics
Chemical Engineering
Molecular biology
Pharmaceutical Biotechnology
Drugs Dev Vaccines Mol. Diagnostics Drug Deliv. Syst.

12. Revolution in science

13.  Drug discovery
 Diagnostic development
 Gene therapy
 Vaccine development
 Drug delivery system development
 Stem Cell Technology

15. Pharmaceutical Biotechnology
 Drug discovery
1. Receptor Technology:
Natural product: - Medicinal plants
- Intrinsic proteins (protein
biotechnology)
2. Targeted drug discovery: bioinformatics screening
computational
High throughput screening

16. Pharmaceutical Biotechnology
 Diagnostic development
•Nucleic acid based: PCR technology
•Immunological based: ELISA technology

17. Pharmaceutical Biotechnology
 Gene therapy
1. Providing normal protein:
* Direct
* Indirect
2. Stopping the process: Antisense technology

18. Pharmaceutical Biotechnology
 Vaccine development
1. Genetically Modified vaccine
2. Recombinant / DNA vaccine
3. Edible vaccine

20. Pharmaceutical Biotechnology
 Drug delivery system development
1. Chemical base:
* Chemical modif ication
* Liposome
1. Immunological base:
* Monoclonal Ab- conjugation

21. Biotech success stories
Human 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.

22. 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.

23. 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.

24. 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.

25. Lecture plan
1. DNA Recombinant
1. Enzyme involved
2. Vector
3. Restriction endonuclease enzyme
4. Cloning selection
2. Expression of Recombinant DNA in prokaryote
1. Manipulation of cloned-gene
2. Vector choices
3. Increase of expression
3. Therapeutic proteins
1. Source and problem of therapeutic proteins
2. Production of therapeutic proteins
3. Modification of therapeutic proteins

26. 4. Stem Cell
a. purpose
b. social impact
c. type of therapy