Pharmaceutical Biotechnology

• Crommelin DA. and Sindelar RD 1997, Pharmaceutical Biotechnology, Harwood Acad. Pub.

• Glick BR and Pasternak JJ, 2000, Molecular Biotechnology: Principles and applications of recombinant DNA. ASM Press. Washington, DC.

• Hardman, JG et al., 2000, Goodman & Gilman’s The Pharmacological basis of therapeutics, 10th ed. McGraw-Hill

• Walsh G., 1998, Biopharmaceuticals: Biochemistry and biotechnology. J. Wiley & Sons.

• Selected papers and power point from the internet

1.www.freemedicaljournals.com

2.www.biomedcentral.com

3.www.nejm.org

4.www.asm.org

5.http://www.bibalex.org/supercourse/ppt.htm

Why should pharmacy students study Pharmaceutical Biotechnology?

Main focus of new drug development

Careers in biotech industry

Careers in big pharma

Appreciation and knowledge about the field.

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 The application of scientific and engineering principles on processing of material by principles on processing of material by

biological agents to provide goods and servicesbiological agents to provide goods and servicesprimarily in pharmaceutical environmentprimarily in pharmaceutical environment

Potential Benefits From Potential Benefits From BiotechnologyBiotechnology

• More accurate disease diagnosis and treatmentMore accurate disease diagnosis and treatment

• Improve crop yield, disease and stress resistanceImprove crop yield, disease and stress resistance

• Microbial production of chemicals, enzymes, Microbial production of chemicals, enzymes, food additives, pharmaceuticals, polymers, etc.food additives, pharmaceuticals, polymers, etc.

• Livestock with enhanced genetic attributesLivestock with enhanced genetic attributes

• Elimination of pollutants and waste materialsElimination of pollutants and waste materials

Potential Social Concerns and Potential Social Concerns and Consequences of BiotechnologyConsequences of Biotechnology

• Organisms harmful to other organisms or Organisms harmful to other organisms or environmentenvironment

• Organisms reduce natural genetic diversityOrganisms reduce natural genetic diversity

• Genetic engineering of humans?Genetic engineering of humans?

• Genetic privacy issuesGenetic privacy issues

• Limited availability to poorer nationsLimited availability to poorer nations

• Undermine traditional agricultural practicesUndermine traditional agricultural practices

Disciplines to contribute Disciplines to contribute

Molecular biologyMolecular biology

MicrobiologyMicrobiology BiochemistryBiochemistry GeneticsGenetics

Chemical EngineeringChemical Engineering

Pharmaceutical BiotechnologyPharmaceutical Biotechnology

Drugs DevDrugs Dev VaccinesVaccines Mol. DiagnosticsMol. Diagnostics Drug Deliv. Syst.Drug Deliv. Syst.

Revolution in science

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

Pharmaceutical Biotechnology

Drug discovery

1. Receptor Technology:

Natural product: - Medicinal plants- Intrinsic proteins (protein

biotechnology)

High throughput screeningHigh throughput screening

2. Targeted drug discovery: bioinformatics screening computational

Pharmaceutical Biotechnology

Diagnostic development

•Nucleic acid based: PCR technology

•Immunological based: ELISA technology

Pharmaceutical Biotechnology

Gene therapy

1.Providing normal protein:* Direct*Indirect

2. Stopping the process: Antisense technology

Pharmaceutical Biotechnology Vaccine development

1.Genetically Modified vaccine

2.Recombinant / DNA vaccine

3.Edible vaccine

Pharmaceutical Biotechnology Drug delivery system

development

1. Chemical base:

* Chemical modification

* Liposome

1. Immunological base:

* Monoclonal Ab- conjugation

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.

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 involved2. Vector3. Restriction endonuclease enzyme4. Cloning selection

2.Expression of Recombinant DNA in prokaryote1. Manipulation of cloned-gene2. Vector choices3. Increase of expression

3.Therapeutic proteins1. Source and problem of therapeutic proteins2. Production of therapeutic proteins3. Modification of therapeutic proteins

4. Stem Cella. purpose b. social impactc. type of therapy