bioteknologi farmasi pendahuluan

7/30/2019 BIOTEKNOLOGI FARMASI PENDAHULUAN

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Pengampu

Sarmoko, S.Farm., Apt.

0812 1531 3748

[email protected] Iskandar Sobri, S.Farm., Apt.
mailto:[email protected]:[email protected]


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PUSTAKA

BR Glick & JJ Pasternak, Molecular Biotechnology

DJA Crommelin & Rd Sindelar, PharmaceuticalBiotechnology

JM Tabor, Genetik Engineering In IndustryPharmacy

Sudjadi, Bioteknologi Kesehatan

Walsh, G., 2007, Pharmaceutical Biotechnology,

John Wiley and Sons Walsh, G., 2003, Biopharmaceuticals: Biochemistry

and Biotechnology, John Wiley and Sons


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Genetika

Bilogi Sel


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Biotechnology Today

Medical Biotechnology

Medical Research

Disease Identification

Genetic Screening

DesignerDrugs/Vaccines

Gene Therapy Tissue/Organ

Engineering

Forensics

DNA Fingerprinting
http://images.google.com/imgres?imgurl=http://www.em1.molmed.uni-erlangen.de/AGSchneider/IUGTscheme.jpg&imgrefurl=http://www.em1.molmed.uni-erlangen.de/AGSchneider/JEB.html&h=779&w=569&sz=51&hl=en&start=6&tbnid=vgPZk-MhtdgyaM:&tbnh=142&tbnw=104&prev=/images?q=gene+therapy&svnum=10&hl=en&lr=


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How big is Biotech? $450 Billion dollars in annual revenues with

projected annual growth of 10-15%.

The US accounts for ~70% of the Global BiotechIndustry.

Biomanufacturing jobs are among the highest

paying in the manufacturing sector. Starting wages of $25,000-$30,000 per year that

can grow to $40,000-$50,000 with experience.


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Bioteknologi

Ilmu yang mempelajari penggunaan agenhayati untuk menghasilkan barang

Ilmu yang mempelajari penggunaan agenhayati/bagiannya untuk menghasilkanbarang/jasa

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Bioteknologi Klasik

Keju

Anggur

Tempe

Tape

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Produksi insulin manusia

Nilai saham Genentech

15 Okt 1980 dalam 20 menit

$ 35 menjadi 71.25

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Contoh Produk Protein

Yang Beredar di Kuba

1981 19901. Anti-meningococcus bc

vaccine

2. Heberon alfa rec.3. Diagnostics

1991 20001. Meningitis vaccine

2. Hepatitis B vaccine

3. Heberkinasa4. Heberon alfa r

5. Hebermin

6. Gavac

7. SUMA System

8. DIRAMIC

9. Hebertrans

10.Culture media

11.Policosanol

12.Trofin

13.Natural products

14.Neurodiagnostic systems

15.Anti-CD3 monoclonal antibody

16.Surfacen

17.Generics

18.Placenta derivatives19.Neurological restoration services

2001 20051. Haemophylus B vaccine2. Combined vaccines (HB-Hib,DPT-Hib, DPT-HBb-Hib,).3. Vaccines and MAbs for cancer therapy4. Meningitis vaccine5. Hepatitis B vaccine

6. Meningococcus ACYW135 vaccine7. HB Uniject vaccine8. EPO (CIM, CIGB)9. Products and equipment for Neurophysioloy and

Neuroinformatics10. New diagnostic systems11. Streptokinase (w/o HSA)12. Neurological restoration services13. Leptospirae vaccine14. MEN B vaccine15. Salmonella vaccine16. Tethanus Toxoid17. GCSF18. Allergens19. Trofin20. Interferon (liquid, w/o HSA)21. Interferon (liofylized, w/o HSA)22. Interferon + ribavirine23. Gamma Interferon24. Interleukin-225. PPG-plus

26. Humanized anti EGF-receptor antibody27. SUMA system28. Agriculture products (GAVAC, Bionematicide)29. EGF (parenteral)30. Hebertrans31. Culture media32. New advanced generics33. Cytostatics34. Technology transfers35. Placenta derivatives

36. EPO plus37. Surfacen38. EGF viscous solution


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Biotechnology Industry in China

Biological Pharmaceutical

-New drug discovery

-Gene therapy

-Biochip-Diagnostic Reagents

Agriculture Breeding(Plant and Animal)

Food Industry (Fermentation)

Transgenic animal

Plant Biotechnology (Anti-adversity plant, haploid breeding)Bio-medical Engineering (Artificail tissues & organs)

Chinese traditional medicines

Biological Reagents and Equipments

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Pharmaceutical

Antibiotics (Penicillin, Streptomycin,Semisynthetic Antibiotics)

Vitamins (Fermentation to produce Vitamin C) Biological Medicines (Interferon, Interleukin,

TNF, HGH, CSF, Calcitonin, etc.)

Diagnostic Reagents (ELISA, PCR, etc) Health Protection Products ( Melatonin, Neuro-

Peptide, Nuclear Acids)

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Biological Medicines in China

Status: Imported and Assembly

Many company produced the same product

(In year 2000 200 companies and 15 medicines get License)

Examples:

*Recombinant Human Interferon (1a, 2a, 2b)

*Recombinant Human Interliukin (IL)

*Recombinant Human Colony Stimulating Factor (CSF)

*Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor

(GM-CSF)

*Recombinant Human Epidermal Growth Factor (HEG)

*Recombinant Human Growth Hormone (HGH)

*Recombinant Human Basic Fibroblast Growth Factor

*Recombinant Human Erythrogenin (EPO)

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Diagnostic Reagents and Kits in China

ELISA (HBV, HCV, HIV, etc)

PCR Kit

Colloid Gold Labeling DNA Chip and Protein Chip

*Antibody Protein Chip Diagnostic System

*Pylorus Spirus Bacillus Antibody ProteinDiagnostic System

*Multiple Cancer Labeling Protein Chip Diagnostic System

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Vaccines and Blood Products in China

Vaccines and Blood Products

Manufacturing by 6 Biological Products Institutes (Beijing,Shanghai, Changchun, Wuhan, Chendu and Lanzhou)

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Trends in Economic

Development The Next Silicon Valley

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Battle for the Dot.Coms

Biotech: NBT (The Next BigThing)

83% of local development agenciesplace bio among their top twopriorities

41 States have biotech programs


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Four Lessons

Biotech tends to cluster

Leaders have an edge

Entrepreneurship & venture capital are key

Outlook for biotech-led economic development

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Entrepreneurship is Key

Research base is necessary but notsufficient

Commercialization Assets Entrepreneurial researchers

Industry-relevant talent

Technical Managerial

Venture capital--surprisingly localized

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Outlook for the Bottom

Biotech strategies are

Expensive

Risky

Time-consuming

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Conclusions

Place still matters, even in a quintessentialknowledge industry

Not just research, but the ability toturn ideas into businesses

The power of clustering provides decisive

business advantages

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BIOTEKNOLOGI MODERN

Menggunakan agensia hayati/bagiandarinya

Menghasilkan barang/jasa

Integrasi kaidah ilmiah dan perekayasaan

Sampai aras molekuler

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Ruang-lingkup

Rekayasa genetik

Teknik biologi molekular : PCR, ELISA

Diagnosis cepat dan tepat: peny. infeksi danpeny genetik

Produksi antibiotik, enzim, hormon, asam amino

Tanaman/hewan transgenik yang menghasilkan

obat Terapi sel punca

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Kekhawatiran

Organisme hasil rekayasa :

Milik pribadi ?

Pengaruh terhadap lingkungan

Prosedur diagnosis melanggar HAM ?

Pengobatan dengan teknik molekuler utk

orang kaya

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(Berg JM et al, 2002)

Human 2.9x109bp


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Kromosomtanpa histon

(Dovlin TM, 2002)


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32(Devlin TM, 2002)


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Strand baru

(Devlin TM, 2002)


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TopoisomeraseDNA


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MENGHAMBAT SINTESIS DNA

MEKANISME OBAT ANTI VIRUS

ACYCLOVIR

MEKANISME OBAT KANKER GANCYCLOVIR

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http://localhost/var/www/apps/mY%20ANIMATIONS/MCB-biomol/DNA-sints1.MOV


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REAKSI PERPANJANGAN
http://localhost/var/www/apps/mY%20ANIMATIONS/MCB-biomol/DNA-sints1.MOVhttp://localhost/var/www/apps/mY%20ANIMATIONS/MCB-biomol/DNA-sints1.MOV


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BPOM PROPOSAL


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MULTIKOPI KLUSTER GENA

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Denaturasi 94oC,Anealing primer 55oC, Sintesis 72oC
http://localhost/var/www/apps/Desktop/movies/PCR.mov


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44(Glick BR & Pasternak JJ, 1994)

Gen Normal

Gen Penderita

Elektroforesis

Hasil amplifikasi dipotong dengan Ensim CvnI

Normal Pembawa Sakit

PCR
http://localhost/var/www/apps/Desktop/ANIMATIONS/3EPCR.MOVhttp://localhost/var/www/apps/Desktop/ANIMATIONS/3EPCR.MOV


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SIDIK JARI DNA


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48(Devlin TM, 2002)


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49(Alberts B, et al, 1994)


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50(Alberts B, et al, 1994)

Splising


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54Berg JM, et al, 2002
http://localhost/var/www/apps/Desktop/movies/cDNA.mov


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EcoRI

Ligase

DNAvektor


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Masterplate

Hibridisasiprotein

Xantibodi

Membrannilon

Lisis,denturasi,dikeringkan

(Berg JM, et al, 2002)
http://localhost/var/www/apps/Desktop/movies/ELISA.movhttp://localhost/var/www/apps/Desktop/movies/ELISA.mov


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TERAPI SEL PUNCA

Stem Cells Are a


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Stem Cells Are aBreakthrough Technology

James Thomson, Ph.D in developmental biology,successfully cultured immortal, human embryonicstem cells in 1997.

Culmination of 17 years of research.

Science 282: 1145-1147 (1998) 1999 Science Magazine Breakthrough of the

Year.

Thomson on the cover of Time Magazine as one of

the top scientists in the U.S.; numerous othernews stories.

Two U.S. patents

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What is so special about HES

cells? Stem Cell = a cell which will reproduce itself and

is also capable of giving rise to a morespecialized cell.

HES Cell = derived from the inner mass cells ofan embryo, is pluripotent i.e. capable of givingrise to anycell type in the body; and is immortal

i.e. continued, indefinite, replication withoutdifferentiation under proper culture conditions.

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