PROF. DR.

SUDJADI

Pengampu
Sarmoko, S.Farm., Apt. 0812 1531 3748 sarmoko@gmail.com Iskandar Sobri, S.Farm., Apt.

PUSTAKA
BR Glick & JJ Pasternak, Molecular Biotechnology DJA Crommelin & Rd Sindelar, Pharmaceutical

Biotechnology JM Tabor, Genetik Engineering In Industry Pharmacy Sudjadi, Bioteknologi Kesehatan Walsh, G., 2007, Pharmaceutical Biotechnology,

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

Genetika Bilogi Sel

Biotechnology Today

Medical Biotechnology Medical Research Disease Identification Genetic Screening Designer Drugs/Vaccines Gene Therapy Tissue/Organ Engineering Forensics DNA Fingerprinting

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 Biotech Industry. 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.

Bioteknologi

Ilmu yang mempelajari penggunaan agen hayati untuk menghasilkan barang Ilmu yang mempelajari penggunaan agen hayati/bagiannya untuk menghasilkan barang/jasa

Bioteknologi Klasik

Keju Anggur Tempe Tape

10

Produksi insulin manusia

Nilai saham Genentech 15 Okt 1980 dalam 20 menit

$ 35

menjadi 71.25

11

Contoh Produk Protein Yang Beredar di Kuba

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. 35. 36. 37. 38.

1. 2. 3.

1981 1990

Anti-meningococcus bc vaccine Heberon alfa rec. Diagnostics

1. Meningitis vaccine 2. Hepatitis B vaccine 3. Heberkinasa 4. 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 derivatives 19.Neurological restoration services

1991 2000

Haemophylus B vaccine Combined vaccines (HB-Hib,DPT-Hib, DPT-HBb-Hib,). Vaccines and MAbs for cancer therapy Meningitis vaccine Hepatitis B vaccine Meningococcus ACYW135 vaccine HB Uniject vaccine EPO (CIM, CIGB) Products and equipment for Neurophysioloy and Neuroinformatics New diagnostic systems Streptokinase (w/o HSA) Neurological restoration services Leptospirae vaccine MEN B vaccine Salmonella vaccine Tethanus Toxoid GCSF Allergens Trofin Interferon (liquid, w/o HSA) Interferon (liofylized, w/o HSA) Interferon + ribavirine Gamma Interferon Interleukin-2 PPG-plus Humanized anti EGF-receptor antibody SUMA system Agriculture products (GAVAC, Bionematicide) EGF (parenteral) Hebertrans Culture media New advanced generics Cytostatics Technology transfers Placenta derivatives EPO plus Surfacen 12 EGF viscous solution

2001 2005

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, NeuroPeptide, 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 *Recombinant *Recombinant *Recombinant (GM-CSF) *Recombinant *Recombinant *Recombinant *Recombinant Human Human Human Human Human Human Human Human Interferon (1a, 2a, 2b) Interliukin (IL) Colony Stimulating Factor (CSF) Granulocyte-Macrophage Colony Stimulating Factor Epidermal Growth Factor (HEG) Growth Hormone (HGH) Basic Fibroblast Growth Factor 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 Protein Diagnostic 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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Genetic Identity in China

Forensic
*Criminal investigation *Paternity testing *Body identification for Victims of Accident

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Trends in Economic Development

The Next Silicon Valley Battle for the Dot.Coms

Biotech: NBT (The Next Big Thing)

83% of local development agencies place bio among their top two priorities 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 not sufficient 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 quintessential knowledge industry Not just research, but the ability to turn ideas into businesses The power of clustering provides decisive business advantages

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BIOTEKNOLOGI MODERN

Menggunakan agensia hayati/bagian darinya 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 dan peny genetik Produksi antibiotik, enzim, hormon, asam amino Tanaman/hewan transgenik yang menghasilkan obat Terapi sel punca

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Ruang lingkup

Human genetics (Human Genome Project) Sidikjari DNA Terapi gena Antisense Vaksin

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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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Human 2.9x109 bp

46
(Berg JM et al, 2002)

30

Kromosom tanpa histon

(Dovlin TM, 2002)

31

(Devlin TM, 2002)

32

Strand baru

(Devlin TM, 2002) 33

Topoisomerase DNA

34

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MENGHAMBAT SINTESIS DNA

MEKANISME OBAT ANTI VIRUS

ACYCLOVIR GANCYCLOVIR

MEKANISME OBAT KANKER

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REAKSI PERPANJANGAN

37

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BPOM PROPOSAL

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MULTIKOPI KLUSTER GENA

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42

Denaturasi 94oC, Anealing primer 55oC, Sintesis 72oC

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PCR

Gen Normal

Gen Penderita

Hasil amplifikasi dipotong dengan Ensim CvnI

Elektroforesis
Normal Pembawa Sakit

(Glick BR & Pasternak JJ, 1994)

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SIDIK JARI DNA

47

(Devlin TM, 2002)

48

(Alberts B, et al, 1994)

49

Splising

50 (Alberts B, et al, 1994)

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53

Berg JM, et al, 2002

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DNA vektor

EcoRI

Ligase

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Membran nilon

Master plate Lisis, denturasi, dikeringkan

Hibridisasi
protein
X

antibodi
(Berg JM, et al, 2002)

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TERAPI SEL PUNCA

Stem Cells Are a Breakthrough Technology

James Thomson, Ph.D in developmental biology, successfully cultured immortal, human embryonic stem 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 other news 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 more specialized cell. HES Cell = derived from the inner mass cells of an embryo, is pluripotent i.e. capable of giving rise to any cell type in the body; and is immortal i.e. continued, indefinite, replication without differentiation under proper culture conditions.

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