Biotek. Pert 1.1 Bu Indah

Introduction Pharmaceutical Biotechnology

Indah woro utami S.Farm M.si

References• Glick, BR and JJ Pasternak, 2003, Molecular Biotechnology: Principles

and Applications of Recombinant DNA, ASM Press, Washington DC• Groves MJ, 2006, Pharmaceutical Biotechnology, 2nd ed., CRC, Taylor &

Francis.• Brown TA, 2006, Gene Cloning & DNA analysis, Blackwell Publ. Oxford• Sven Frokjaer and Lars Hovgaard, 2000, Pharmaceutical Formulation

Development of Peptides and Proteins, CRC Press• Kayser O. And Muller RH, 2004, Pharmaceutical Biotechnology, Wiley

VCH.• Saltzman W. M, Tissue engineering: engineering principles for the design

of replacement organs dan tissues, Oxford university press, 2004 (TS)• W.W. Minuth, R. Strehl, K. Schumacher, Tissue Engineering: Essentials for

daily laboratory work, Wiley-VCH, 2005 (TS)

Presentation AssignmentEach group should choose a recombinant product in the field of pharmacy available

commercially in Indonesia and assignment should contain:1. Introduction2. Nature of active component3. Dosage form(s) and name of producers / companies4. Usage and explanation of disease prevented/treated by the product5. Production system including expression system including host cells, purification and

characterization of active compound6. Conclussion7. References (refer to the journal, not website)

Topic hepatitis B vaccine, alteplase, somatotropin and transtuzumab

file name Biotech_GroupX_productname to [email protected]

Topics1. Introduction of pharmaceutical biotechnology include nucleic

acid, protein flow of genetic information2. Recombinant DNA technology and manipulation of gene

expression3. Detection of infection and genetic disease with Replication

and Polymerase Chain Reaction (PCR) 4. Gene Therapy, Transgenic Plant, Biosimilar Products 5. Therapeutic Protein, Vaccine and Technology for

Recombinant Protein Production 6. Monoclonal Antibody and Technology for Monoclonal

Antibody Production 7. Presentation assignment

Introduction General view of pharmaceutical biotechnology, explanation about pharmaceutical biotechnology and its applications in pharmacy field, examples of products produced by recombinant DNA technology. Biotechnology include nucleic acid, protein, role of transcription and translation in molecular biotechnology.

Recombinant DNA technology and manipulation of gene expression

Basic principle of recombinant DNA technology, vectors: cloning and expression vectors, strategy for DNA isolation, ligation, transformation, clone characterization. Use of expression vector, strategy of overproduction, selection of vectors, selection of host cell.

Detection of infection and genetic disease with Replication and Polymerase Chain Reaction (PCR)

Replication in prokaryotes and eukaryotes; basic principle of Polymerase Chain Reaction (PCR), modified PCR

Gene Therapy, Transgenic Plant, Biosimilar Products

Explanation, strategy and principles of gene therapy (in vivo, ex vivo), aims of gene therapy, examples of gene therapy, explanation of transgenic plants, principles of construction of transgenic plants, use of transgenic plants, examples transgenic plants.

Therapeutic Protein, Vaccine and Technology for Recombinant Protein Production

Prokaryotic systems, eukaryotic systems (lower and higher eukaryotes), therapeutic proteins and vaccines

Monoclonal Antibody and Technology for Monoclonal Antibody Production

Hibridoma technology and recombinant DNA technology to produce monoclonal antibody, monoclonal antibodies for therapeutic purposes and their mode of actions

Recombinant DNA technology• 14 October 1980, price of shares of biotechnology company,

Genentech increased considerably from$35 to $89.• Genentech: a company specializing in recombinant DNA

technology, genetic engineering, gene transplantation and gene cloning.

• Cloning of insulin gene in Escherichia colito produce human insulin.

Recombinant DNA technology

• 1973: Stanley Cohen and Herbert Boyer discovered a method to transfer genetic information (gene) from one organism to others.

• 1976: Herbert Boyer cofound Genentech, the first company in USA which applies Recombinant DNA technology

• 1978:Somatostatin, a regulator for human growth hormoneis the first human protein produced by Recombinant DNA technology

Commercialization of molecular biotechnology

• In 1985: > 400 biotechnology companies names with word “gene”: Biogen, Amgen, Calgene, Engenics, Genex, and Cangene.

• Now: > 1300 companies in USA and > 2500 world-wide

Scientific disiplines contributes to molecular biotechnology