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Pharmaceutical

Biotechnology
Debbie S. Retnoningrum; Catur Riani; Tri Suciati;
Heni Rachmawati; Ana Indrayati

School of Pharmacy, ITB

School of Pharmacy ITB Pharmaceutical Biotechnology-FA 4202 Introduction 1


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.

Grietje Moleme, Dirk K.F.Meijer, Drug Targeting:Organ-spesific strategies,


Wiley-VCH, 2001 (HR)
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)
School of Pharmacy ITB Pharmaceutical Biotechnology-FA 4202 Introduction 2
TOPICS
1. Introduction (DSR)
2. Nucleic Acid and Protein, Flow of Genetic Information (DSR)
3. Replication and Polymerase Chain Reaction (PCR) (DSR)
Quis 1: topics 2 and 3
4. Recombinant DNA technology (DSR)
5. Manipulation of Gene Expression (DSR)
6. Therapeutic Protein, Vaccine and Technology for Recombinant
Protein Production (DSR)
Quis 2: topics 4, 5, 6
7. Monoclonal Antibody and Technology for Monoclonal Antibody
Production (CR)
8. Mid semester exam

School of Pharmacy ITB Pharmaceutical Biotechnology-FA 4202 Introduction 3


TOPICS

9. Protein Isolatian and Purification (AI)


10. Analysis of Recombinant Product (CR)
11. Gene Therapy and Transgenic Plant (CR)
12. Biosimilar Products (CR)
13. Oral Presentation (CR/AI)
14. Formulation of Recombinant Proteins (HR)
15. Targeted Drug Delivery (HR)
16. Tissue Engineering (TS)
17. Final Exam

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1. Introduction (DSR)

General view of pharmaceutical biotechnology,


explanation about pharmaceutical biotechnology
and its applications in pharmacy field, examples of
products produced by recombinant DNA technology

Glick, BR and JJ Pasternak, 2003, Molecular Biotechnology:


Principles and Applications of Recombinant DNA, ASM Press,
Washington DC (hal 3 13)
Groves MJ, 2006, Pharmaceutical Biotechnology, 2nd ed., CRC,
Taylor & Francis (1 4)

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2. Nucleic acid and protein, flow of genetic
information (DSR)

Nucleic acid, polypeptide and protein, transcription and


translation in prokaryotes and eukaryotes, role of
transcription and translation in molecular biotechnology
Post test 1

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3. Replication and Polymerase Chain Reaction
(PCR) (DSR)
Replication in prokaryotes and eukaryotes; basic
principle of Polymerase Chain Reaction (PCR), modified
PCR
Quiz 1: topics 2 and 3

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4. Recombinant DNA technology (DSR)

Basic principle of recombinant DNA technology, vectors:


cloning and expression vectors, strategy for DNA
isolation, ligation, transformation, clone characterization

Post test 2

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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 coli to produce
human insulin. Genentech, building 32

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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
hormone is the first human protein produced by
Recombinant DNA technology

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Emergence of molecular biotechnology

A study of the industrial production of good and services


by processes using biological organisms, systems, and
processes.

Scientific disiplines: microbiology, biochemistry and


chemical engineering

Raw UPSTREAM Fermentation and Downstream Pure


material PROCESSING biotransformation processing product

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Emergence of molecular biotechnology

The use of recombinant DNA technology in


biotechnology:
Molecular biotechnology
Using Molecular biotechnology
Creation of new strains / mutants rather than isolation/
screening of strains from nature
Cells, plants, animals are used as biological factories

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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

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Scientific disiplines contributes to molecular
biotechnology

MOLECULAR BIOLOGY

MICROBIOLOGY CROPS

BIOCHEMISTRY DRUGS
MOLECULAR
IMMUNOLOGY
BIOTECHNOLOGY VACCINES

GENETICS DIAGNOSTICS

CHEMICAL LIVESTOCK
ENGINEERING
CELL BIOLOGY

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5. Manipulation of gene expression (DSR)

Use of expression vector, strategy of


overproduction, selection of vectors, selection of
host cell.
Post test 3

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6. Therapeutic proteins, vaccines and technology to
produce recombinant proteins (DSR)

Prokaryotic systems, eukaryotic systems (lower and


higher eukaryotes), therapeutic proteins and vaccines

Quiz 2: topics 4 and 5


STREPTOKINASE INTERFERON
W6 W7 W8 F1 F2 F3 M kDA
97
72
66 kDa
45

30
33
kDa
20.1 IFN 2b

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7. Monoclonal antibody and technology to
produce monoclonal antibodies (CR)
Hibridoma technology and recombinant DNA technology
to produce monoclonal antibody, monoclonal antibodies
for therapeutic purposes and their mode of actions
Post test 4

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8. Mid semester exam

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9. Protein Isolation and Purification (AI)

Strategy for protein isolation for intracellular and


extracellular proteins, strategies for recombinant protein
purification (gel filtration, ion exchange, reverse-phase,
affinity, hydrophobic interaction chromatographies)
Post test 5

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10. Analysis of recombinant products (CR)

Protein-based analyses: determination of protein


concentration, amino acid sequencing, peptide maping,
electrophoresis (SDS-PAGE, native PAGE,
electrofocusing, two-dimensional electrophoresis), Western
blot. DNA-based analysis: sequencing, hibridization
Post test 6

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11. Gene therapy and transgenic plants (CR)

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.

Quiz 3: topics 9, 10 and 11

Written assignment and oral presentation

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12. Biosimilar products (CR)

Definition; regulation; patent situation; first generation


biosimilar products: EPO, CSFs, bGH, insulin, hepatitis
B vaccine, factor VIII, IFN; development of biosimilar and
its requirements
Post test 7
erithropoetin
Interferon alpha

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ORAL PRESENTATION
(selected group)

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13. Formulation of recombinant proteins (HR)
General considerations of protein and peptide
formulation, routes of protein and peptide administration,
excipients in protein and peptide formulation, techniques
in protein and peptide formulation, quality control of final
products

erythropoetin somatostatin

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15. Targeted-drug delivery system (HR)

Definition of conventional and targeted-drug delivery


system, types of targeted-drug delivery system, urgency
and aims of drug targetting, ligand, homing device dan
homing molecule, design of targeted-drug, mechanisms
of drug targeting

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16. Tissue engineering (TS)

Tissue engineering as alternative to organ


transplantation, advantages of tissue engineering
compared to other therapy, basic principles of tissue
engineering, main components of tissue engineering.

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Grading system

Midsem: 35 %
Post test: 5 %
Quiz: 5 %
Participation: 5 %
Written assignment: 5 %
Oral presentation: 5 % (only for selected groups)
Final exam: 40%

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Class rules
After class is commenced, students are not allowed to enter the
class
No remedial for post test (the mark will be 0)
No remedial
It is NOT allowed to do copy paste from any kinds of resources
including from previous assignments
Chatting in any form will be punished according to academic
rules
No cellular phone during class
Cellular phone & E- mail :
- DSR: 0812 204 4266 / 022 9125 4266 / debbieretnoningrum@yahoo.com
- CR: 081364270120 / c_catur@yahoo.com
- AI: 0815 626 6891 / anaindrayati@fa.itb.ac.id

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