Spesifikasi Bioproduk
Spesifikasi Bioproduk
Spesifikasi Bioproduk
2
Transgenic Animal
Desired DNA is
added to an egg
cell.
Selective Breeding
• Breed only those plants
or animals with
desirable traits
Simple process
- Direct use of or isolation from original biological sources
- Fermentation
Modern Biotechnology (After 1970s)
GAS Cell
Cellculture
culture
GAS
Recovery PRODUCT
PRODUCT
LIQUID Biocatalyst Bioreactor
LIQUID product
LINES
LINES
SOLID Enzymatic
Enzymatic
SOLID
PLANTS
1. disease-resistant and
insect-resistant crops
2. Hardier fruit
3. 70-75% of food in
supermarket is genetically
modified.
Genetically modified organisms are
called transgenic organisms.
TRANSGENIC ANIMALS
.
This goat contains a human gene
that codes for a blood clotting
agent. The blood clotting agent
Human DNA in
can be harvested in the goat’s
a Goat Cell
milk.
Alur Penelitian Seed Vaksin :
Produksi Vaksin Flu Burung (Skala Industri)
MDCK cells
A/TDC/05 Propagasi
(WT)
TAB
Sel 293 T
A/TDC/05
(RG)
SEL Vero
Virus PR-8
Virus Seed Vaksin Flu Burung
RG
Eksternal gen : A/Indonesia/Unair/2005
HA : RG (avirulent type): NA (Riset I)
Internal gen:PR8 (ATCC No. VR-95 & VR-1469)
HA HA
NA NA
PLASMID REVERSE GENETIC
pCAGGS: PB-1;PB-2;PA;NP
(PR-8)
Mutagenesis Cleavage site
RESRRKKR
RETR
Uji Patogenisitas : Telur Ayam Bertunas
A/Ind/Unair/2005 (WT)
Index : 2,94 (Ayam mati hari ke 2)
A/Ind/Unair/2005 (RG)
Index : 0,00 (Ayam hidup hari ke 10)
PROPOSAL MP3EI (2013-2015)
GARIS BESAR KERJA SAMA
Rencana Strategi
AIRC - Pusat Penelitian
Simple process
- Direct use of or isolation from original biological sources
- Fermentation
Modern Biotechnology (After 1970s)
DNA microarray
Required disciplines
- Basic biology, - Mass/Energy balance, - Thermodynamics
- Physical, organic chemistry / Pharmacology
- Biochemical engineering : Extension of chemical engineering
principles to biological system Bioreaction engineering, plane
design, process control, optimization, and separations
Biotechnology Bio-industry
Basic Biology - Pharmaceutical
Engineering principles
- Biotech. company
Major application areas
• Health care / Diagnostics :
- Development of therapeutics: efficacy, toxicity
- Diagnosis : early detection and prevention of diseases
Branches of Biotechnology
• Blue biotechnology : Marine and aquatic
applications of biotechnology
• Green biotechnology : Agricultural applications
• Red biotechnology : Medical applications
• White biotechnology : Industrial applications
Typical examples of Bio-Products
Company Procucts
Vitamin B-2
Methoxy isopropyl amine (chiral intermediate)
BASF Styrene oxide
Amino acids
GAS Cell
Cellculture
culture
GAS
Recovery PRODUCT
PRODUCT
LIQUID Biocatalyst Bioreactor
LIQUID product
LINES
LINES
SOLID Enzymatic
Enzymatic
SOLID
White Biotechnology
Value chains from renewable sources
Alternative energy sources
Enzymes
Therapeutics
• Treatment of Gaucher’s disease
Chemical company devoting to Biotechnology : BASF
Ecoflex®
Therapeutic proteins
High specificity and less toxicity high safety and efficacy
Therapeutic proteins
- Antibodies, proteins, enzymes, peptides etc.
ex) EPO, Interferon, Insulin, Avastin, Enbrel, Remicade, Herceptin,
EPO (Erythropoietin) : Stimulating the proliferation of red blood cells
Herceptin : Mab against EGFR2(Epidermal growth factor receptor 2)
Avastin : Mab against VEGF (Vascular endothelial growth factor)
Remicade: Mab against TNF-α (Tumor necrosis factor- α)
World market
- EPO alone : ~ $ 11 Billion per year
- $ 50 Billion (2007) $ 190 Billion (2015)
- Antibodies > 50 %
- Intensive investment in monoclonal antibodies: Biosimilar
CDRS 1 2
3 1
3
FR
VL VH
Blockbuster Therapeutic Antibodies
Approved Market Antibody
Product Target Indication Company
Year size(07)* Type
Non-Hodgkin's
1997 Rituxan CD20 Genentech 4,603 Chimeric
lymphoma
RA, Chron’s
1998 Remicade TNF- J&J 5,234 Chiemric
disease
Genentech
2003 Raptiva CD11a Psoriasis 211 Humanized
Xoma
Imclone
2004 Erbitux EGFR Colorectal cancer Bristol- 1,336 Chiemric
Myers
GlaxoSmithKline,
Amgen Strategic alliance or merger
Bristol-Myers-Squibb,
Boehringer Ingelheim between big pharma and
Eli Lilly, biotech companies
Roche,
Avidia, Ammunex. Affibody,
Ablynex, Adnexus Therapeutics
…….
Non-antibody scaffolds
Human lipocalin
Ankyrin
Human fibronectin Z domain of Staphylococcal protein A
Therapeutic Enzymes
Sales
Disease Product Developer (US$Millions) Features
2004 2007
Glucocerebrosidase
Ceredase® Genzyme 443 N/A
Purified from human placenta
Gaucher’s Produced in CHO cells
932
Cerezyme ® Genzyme 1,048 3 Exoglycosidases process
(2005)
for Terminal Mannose
Fabrazyme® Genzyme 209 397 alpha-galactosidase
Fabry’s Mannose-6-phosphate for
Replagal TKT 57 168 Glycotargeting
Approved
Pompe Myozyme® Genzyme alfa-glucosidase
(2006)
- Found by Phillipe
Glucosyl Ceramide
Gaucher in 1882
- Biochemical basis O=C-CH2-CH2-CH2-(CH2)n-CH3
for the disease in N OH
1965 by Brady et al..
CH2-CH-CH-CH=CH-(CH2)12-CH3
Glucocerebrosidase
Glucocerebrosidase(b-glucosidase)
(b-glucosidase)
O=C-CH2-CH2-CH2-(CH2)n-CH3
N OH
OH-CH2-CH-CH-CH=CH-(CH2)12-
CH3
Autosomal recessive inheritance Glucose Ceramide
Lysosomal storage diseases (LSDs): Lysosomal
Enzymes Lysosomes: Cellular organelles containing
acid hydrolase enzymes to break down waste
materials and cellular debris
Cells’ garbage disposal system
• Digestive organelle in the cell
• Contains ~40 hydrolytic enzyme
(1) The ER and Golgi apparatus make a lysosome
• Acidic pH (about pH4.8) within the lysosome
(2) The lysosome fuses with a digestive vacuole is required for lysosomal enzymes to be
(3) Activated acid hydrolases digest the contents active
(LSD)
Lysosome Lysosome with
substrate
accumulation
Nucleus
Mitochondria
Glucocerebrosides Exocytosi
Normal cells s
Glucocerebrosidase
+
Digestive glucose ceramide Residual
vacuole vacuole
Distended abdomen
Digestive
vacuole No exocytosis
Diagnostics
• Diagnosis of disease as early as possible :
Best solution compared to treatments
Industrial
Residual
Anaerobic
Digestor
Bio
Methane CHP Heat & Power €.14/KWh
Fertilise
Digestate
r Fertiliser €250/MT
Leachate
Process
Bio Platform
Lactic Acid
€400/MT
Silage Press
Agri Press Juice Separation Amino Acid
Residue Feed €350/MT
Industrial Press Cake Supplement
Residual
C5/C6 Sugars
Enzyme
Separation Food or €400/MT
Hydrolysis Fermentation
Separati C5 Sugar
on Fraction
Anaerobic
Digestor
Bio
Methane CHP Heat & Power €.14/KWh
Fertilise
Digestate
r Fertiliser €250/MT
Leachate
Process
Bio Platform
Lactic Acid
€400/MT
Silage Press
Agri Press Juice Separation Amino Acid
Residue Feed €350/MT
Industrial Press Cake Supplement
Residual
C5/C6 Sugars
Enzyme
Separation Food or €400/MT
Hydrolysis Fermentation
Sugars
Bio
Methane CHP Heat & Power €.14/KWh
Fertilise
Digestate
r Fertiliser €250/MT
Leachate
Process
Bio Platform
Lactic Acid
€400/MT
Silage Press
Agri Press Juice Separation Amino Acid
Residue Feed €350/MT
Industrial Press Cake Supplement
Residual
C5/C6 Sugars
Enzyme
Separation Food or €400/MT
Hydrolysis Fermentation
€400
Gasificatio
Bio Char Heat & Power €.14/KWh
n
Thermo Chem Platform
Agri
Residue
Wastes
Energy
Crops
Ethyl Levulinate
Esterification €600/MT
Hydro Bio Diesel
thermal
Pyrolysis
PH
Crude Stabilisation
Bio Oil Deoxygenation Bio Oil €350/MT
Gasificatio
Bio Char Heat & Power €.14/KWh
n
Sugars
Separati C5 Sugar Acids €400/MT
Organic
on Fraction
Anaerobic Bio Plastics €750/MT
Digestion
(Short Fermentation
Bio Ethanol €515/MT
Residence)
Bio
Methane CHP Heat & Power €.14/KWh
Fertilise
Digestate
r Fertiliser €250/MT
Leachate
Process
Low cost production of multiple high value products from low cost biomass =
Economic Viability
BIOLOGICAL PROCESS CATEGORIES
Products fungicides,
growth
lifecycle
growth
or irrigation
pond
enhancers enhancement remediation
Remediation
Bio-Energy, Cellulosic Slaughter or byproducts
ethanol fecal waste (microbial
Renewable fermentation digestion to lipids, omega
Chemicals , algal lipids bio-gas 3,6 fatty
acids)
Corn
Seed
Grow Harvest
Fertilizer
Store Transport
to Bioprocessing
Bioprocessing
Enzymes Yeast
Glucose
Delivery to markets
Infrastructure
Corn Stover: 1 to 2 tons /acre
Leaves
Cobs
Stalks
Roots
Bioethanol Production
Feedstock
Preparation
Pretreatment
Hydrolysis Ethanol
of Solids Fermentation
Cellulose Pretreatment gives
Lignin enzyme accessible
substrate
Amorphous Pretreatment
Region
Crystalline
Region
Hemicellulose
Components of plant cell walls
Cellulose
Fermentable sugars obtained
from cellulose in 1819
Lignin
Hemicellulose Extractives
(need special yeast to Ash
convert to ethanol)
Xylose Glucose
NAD(P)H
NAD(P)+
Xylitol Glucose-6-P
NAD+
Glyceraldehyde-3-P
Xylulose-5-P NAD+
NADH
3-Phosphoglycerate
PPP Ethanol
NADH NAD+
Phosphoenolpyruvate
Ho et al