Pharmaceutical Biotechnology - Download

School of Pharmacy ITBSchool of Pharmacy ITB Pharmaceutical BiotechnologyPharmaceutical Biotechnology--FA 4202FA 4202 Introduction Introduction 11

Pharmaceutical Pharmaceutical BBiotechnologyiotechnology

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

School of Pharmacy, ITB


REFERENCESREFERENCES• 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)


TOPICSTOPICS

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 34. 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 AntibodyProduction (CR)

8. Mid semester exam


TOPICSTOPICS

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


1. Introduction (DSR)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)


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


3. Replication and Polymerase Chain Reaction 3. Replication and Polymerase Chain Reaction (PCR) (DSR)(PCR) (DSR)

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

• Quiz 1: topics 2 and 3


4. Recombinant DNA technology (DSR)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


Recombinant DNA technologyRecombinant 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


Recombinant DNA technologyRecombinant 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


Emergence of molecular biotechnologyEmergence 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 material

Pure product

UPSTREAM PROCESSING

Fermentation and biotransformation

Downstream processing


Emergence of molecular biotechnologyEmergence 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


Commercialization of Commercialization of molecular biotechnologymolecular 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 Scientific disiplines contributes to molecular biotechnologybiotechnology

MOLECULAR BIOLOGY

MOLECULAR BIOTECHNOLOGY

MICROBIOLOGY CROPS

BIOCHEMISTRY DRUGS

IMMUNOLOGY VACCINES

GENETICS DIAGNOSTICS

CHEMICAL ENGINEERING

LIVESTOCK

CELL BIOLOGY


5. Manipulation of gene expression (DSR)5. Manipulation of gene expression (DSR)

• Use of expression vector, strategy of overproduction, selection of vectors, selection of host cell.

• Post test 3


6. T6. Thherapeutic proteins, vaccines and technology to erapeutic proteins, vaccines and technology to produce recombinant proteins (DSR)produce recombinant proteins (DSR)

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

• Quiz 2: topics 4 and 5

kDA97

6645

30

20.1

W6 W7 W8 F1 F2 F3 M

STREPTOKINASE

72 kDa

33 kDa

IFN α2b

INTERFERON


7. Monoclonal antibody and technology to 7. Monoclonal antibody and technology to produce monoclonal antibodies (CR)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


8. Mid semester exam8. Mid semester exam


9. Protein Isolation and Purification (AI)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


10. Anal10. Analyysis of recombinant products (CR)sis 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


11. Gene therapy and transgenic plants (CR)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


12. Biosimilar products (CR)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

Interferon alphaerithropoetin


ORAL PRESENTATIONORAL PRESENTATION(selected group)(selected group)


13. Formulation of recombinant proteins (HR)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


15. Targeted15. Targeted--drug delivery system (HR)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


16. Tissue engineering (TS)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.


Grading systemGrading system

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


Class rulesClass 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 / [email protected] CR: 081364270120 / [email protected] AI: 0815 626 6891 / [email protected]

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Pharmaceutical Biotechnology - Download