Introduction of Chunghwa Chemical Synthesis Biotech Co., Ltd.
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Chunghwa Chemical Synthesis & Biotech Co., Ltd. Introduction of Chunghwa Chemical Synthesis & Biotech Co., Ltd.
Transcript of Introduction of Chunghwa Chemical Synthesis Biotech Co., Ltd.
Chunghwa Chemical Synthesis & Biotech Co., Ltd.
Introductionof
Chunghwa Chemical Synthesis& Biotech Co., Ltd.
Profile Founded in 1964 First registered and one of the largest bulk pharmaceutical
chemical manufacturers in Taiwan First Taiwan FDA approved plant (1984)
Turning Points in 1997 Formed the New Management Team in 1997 Invested US$ 20 million to construct
• 4 cGMP Plants for Synthetic Products• 2 cGMP Plants for Biotechnology Products
Established US Sales Office-Pharmaports in 2000 Products Developing both synthetic & biotech products Participate new drug development and contract manufacturing
Global Market Oriented with Emphasis on U.S.A., Europe, Japan
Initial public offering on December 20, 2010 Obtain the necessary land for plant expansion in 2012
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Brief History of CCSB
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Sales from 1998 to 2013
0
5,000
10,000
15,000
20,000
25,000
30,000
35,000
40,000
45,000
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
USD Thousands
Domestic Export
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Sales from 1998 to 2013
0
5,000
10,000
15,000
20,000
25,000
30,000
35,000
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
USD Thousands
Synthetic Products Biotech Products Contract Manufacturing
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Sales Area in 2013
Asia35.0%
US53.9%
Europe6.8%
ROW0.3%
Domestic4.0%
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Management Team
President – Dr. Steve Chang– D.Sc. Chemistry, Univ. Texas at Arlington– Abbott Laboratories, Abbott Parks, IL, 1989‐1998– QA/QC Manager, CCSB 1999‐2002– VP of Operation 2002‐2004– President since 2004
Chief Operation Officer, Pharmaports – Dr. Jack Yen– Ph.D., Chemistry, Drexel University – Johnson & Johnson Pharmaceutical R&D 1996‐2007– Glaxo SmithKline Pharmaceutical R&D 1988‐1996– Wyeth Laboratories Pharmaceutical R&D 1986‐1988
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Management Team (cont.)
VP of Business Management ‐Mr. Denry Huang– Deputy Plant Manager
– Marketing & Sales Manager
– General Manager, Shaoguan City Fermentec Co., China
Plant Manager – Mr. K. H. Tseng– B.E. in Chemical Engineering
– Pharmaceutical Manufacturing since 1976
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Management Team (cont.)
Synthesis R&D Director – Dr. Kevin Lee– Ph.D. Chemistry, National Tsing Hua University
– API R&D since 1994
Biotech R&D Director – Dr. Alex Mai– Ph.D. Chemistry, National Taiwan University
– API R&D since 1994
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Analytical R&D Director – Dr. H. Y. Cheng– Ph.D., Analytical Chemistry, Ohio State University, Columbus, Ohio
– Lead Researcher, Industrial Technology Research Institute, Taiwan, 2009‐2011
– Applications Lab Manager, Eksigent Technologies, Dublin, CA, 2005‐2008
– Various Research and Management Positions in Drug Discovery and Pre‐Clinical Development, GSK Pharmaceuticals, King of Prussia, PA, 1984 ‐ 2004
Regulatory & QA Manager – Dr. W. P. Wang– Ph.D. Ch.E., University of Massachusetts
– Experienced in API R&D, Production and QA/QC since 1995
Management Team (cont.)
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CCSB Organization Chart
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Research and Development
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R & D Manpower
Synthesis Biotech Analytical Total %
Ph.D. 4 3 1 8 19.5%
Master 8 9 4 21 51.2%
Bachelor 5 3 2 10 24.4
Others 0 2 0 2 4.9%
Total 17 17 7 41
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Biotech Capabilities
Strain ImprovementObtain high producer strain through screening and mutation
Fermentation Process Development & CommercializationPravastatin Sodium; Rapamycin (Sirolimus); Mycophenolate Mofetil; Tacrolimus(FK506);Caspofungin; Micafungin; Anidulafungin;Temisirolimus; Everolimus; Biolimus; Zotarolimus
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Contract Research & Development
Antiarrhythmia Drug– Collaborated with National Science Council & National Taiwan
University in Taiwan Blood Substitute, Antioxidant Drugs
– Collaborated with SynZyme in U.S. funded by DOD & NIH Antiradiation Drugs
– Collaborated with SynZyme in U.S. Macrolide
– Collaborated with a U.S. Biotech company COX II Inhibitor
– Collaborated with a German company
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Official cGMP Inspections
Year Authorities Nation Product2002 FDA US Methocarbamol
2005 FDA US Pravastatin
2006 TFDA Taiwan Perindopril
2007 KFDA Korea Methocarbamol
2008 NIP Hungary Perindopril
2008 TFDA Taiwan Trandolapril
2009 Koln Germany Pravastatin
2009 TFDA Taiwan GMP Systems
2011 FDA US Dexb; MMF; Tacrolimus
2012 Koln Germany Pravastatin
2013 TFDA Taiwan OLO; RAPA
2013 PMDA Japan Tacrolimus
2013 KFDA Korea Tacrolimus
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Active US DMF List
DMF 23435Mycophenolate Sodium
DMF 24372Mycophenolate Mofetil HCl
DMF 26271Ethyl lcosapentate
DMF 26819Everolimus Pre‐Mix
DMF 27216Everolimus
DMF 27585Caspofungin Acetate
DMF 8625Dexbrompheniramine Maleate
DMF 13080Methocarbamol
DMF 14234Guaifenesin
DMF 14235Pravastatin Sodium
DMF 17399Rapamycin
DMF 17400Carisoprodol
DMF 17573Trandolapril
DMF 18494MycophenolateMofetil
DMF 18985Tacrolimus
DMF 22430Olopatadine
DMF 23213Tacrolimus SD20
DMF 23434Metaxalone
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Equipment for Synthesis
Glass‐lined Reactors: Total Volume 24,000 LStainless Steel Reactors: Total
Volume 140,000 L
Hot‐Air Tray DryersVacuum Tray DryersDouble‐cone Dryers
Hammer MillFitz MillJet Mill
Hastelloy CentrifugesStainless Steel Centrifuges
Dryers
Reactors
SynthesisCentrifuges
Mills
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Equipment for Biotech
1,250 L – 30,000 L FermentorsTotal 137,000 L Fermentation Volume
Filter Press Disk CentrifugeColumnsUltra‐filtrationPreparative HPLCLyophilizer
Lyophilization
Biotech
Fermentation
Purification
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Equipment for Analytical
Analytical
GC/MS
LC/MS
UPLC
X-ray Powder
Diffraction
GC
HPLC
206 inch MPLC system
2 inch and 3 inch HPLC column
Instrumentation
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Waters preparative HPLC system 2 inch DAC column
Instrumentation (cont.)
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Instrumentation (cont.)
Powder XRD
HPLC
GC
LC Mass
UPLC
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Instrumentation (cont.)
GC/MS
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Instrumentation (cont.)
GE AKTA Purifier UPC 100
BioTek Synergy H1 Hybrid Reader
KvickLab Cross Flow System
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Instrumentation (cont.)
Pyros Kinetix Flex Automatic Endotoxin Detection System
GEA Niro High Pressure Homogenizer
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Instrumentation (cont.)
Mbraun Glove box
Type: UNILAB-BBio Rad ChemiDoc XRS+ Imaging System
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Location & Buildings
CCSB
Taoyuan Int’l Airport
Located in Shu‐Lin,New Taipei City
20 km South West of Taipei
34,000 m2
244 EmployeesTaipei Songshan Airport
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CCSB Campus Layout
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Chunghwa Chemical Synthesis & Biotech
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cGMP Commercial Plants
cGMP Plants
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Synthetic Pilot Plant
75 L Stainless Steel Reactor
50 L Glass Lined Reactor
50 L Cone Dryer & 25” Centrifuge
32Freeze Dryers
Synthetic Pilot Plant (cont.)
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Synthetic Commercial Plants
3,000 L Glass Lined Reactors
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Synthetic Commercial Plants (cont.)
Stainless Steel Reactors
Cone Dryer in Controlled Room
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Biotech Pilot Plant
5 L Fermentor
600 L Fermentor
22 L Fermentor
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Biotech Commercial Plant
ABEC 75L, 250L & 1250 L Bioreactors
ABEC 250LBioreactors
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Biotech Commercial Plant (cont.)
6,000 L Fermentor
Feed Tanks of Fermentor
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Biotech Commercial Plant (cont.)
20,000 L & 30,000 L Fermentors
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Biotech Commercial Plant (cont.)
5,000 L Glass-lined and Stainless SteelReactors for Purification Process
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Biotech Commercial Plant (cont.)
Recovery & Purification Equipment Ultra Filtration
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Whole Drug Life Cycle Support
Pre‐clinical Phase I/II Phase III/Launch
Drug Life Time
grams kilograms tons/multi‐tons
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Summary of CCSB
Over 45 years of API manufacturing experience FDA and Health Authorities approved cGMP facilities for
synthesis & biotech APIs Fully cGMP trained and experienced personnel Strong R&D support Proven records for cost effective and on‐time delivery of
contract manufacturing from lab to commercial scales Good communication skills & prompt response
