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 Assignment
Each group should choose a recombinant product in the field of pharmacy available
commercially in Indonesia and assignment should contain:
1. Introduction
2. Nature of active component
3. Dosage form(s) and name of producers / companies
4. Usage and explanation of disease prevented/treated by the product
5. Production system including expression system including host cells, purification and
characterization of active compound
6. Conclussion
7. References (refer to the journal, not website)

Topic hepatitis B vaccine, alteplase, somatotropin and transtuzumab

file name Biotech_GroupX_productname to indah.oetami@gmail.com
Topics
1. Introduction of pharmaceutical biotechnology include
nucleic acid, protein flow of genetic information
2. Recombinant DNA technology and manipulation of gene
expression
3. 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