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
2
Brief History of CCSB
3
Sales from 2004 to 2016
USD Thousands
0
5,000
10,000
15,000
20,000
25,000
30,000
35,000
40,000
45,000
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Export
Domestic
4
Sales from 1998 to 2016
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 2014 2015 2016
USD Thousands
Synthetic Products Biotech Products Contract Manufacturing
5
Americas53.03%
Americas53.03%
Domestic8.22%
Domestic8.22%
Europe7.9%
Europe7.9%
Asia30.79%
Asia30.79%
Sales Area in 2016
ROW0.06%ROW0.06%
6
Management Team
President – Dr. Chih-Ping Yang– Ph.D., Organic Chemistry, Univ. Texas at Austin, USA– General Manager, Chugai Pharma Taiwan 2005-2015– Founder, President & CEO, CytoPharm, Inc., Taiwan 2003-2004– President & CEO, GeneTrol Biotherapeutics, Inc., Oakland, California, USA
2002-2004
VP of Administration Management - Mr. Denry Huang– Deputy Plant Manager
– Marketing & Sales Manager
– General Manager, Shaoguan City Fermentec Co., China
7
VP of Sales Management - Mr. Chuan Wen Chen– Marketing Director, Chugai Pharma Taiwan 2009 - 2016
– Business Development & Pharmaceutical Consultant, A-strong Co., Ltd. 2008 - 2009
– General Manager/Pharmaceuticals, Abbott Pharmaceutical Division, Taiwan 2001 - 2008
– Marketing Director, Serono Taiwan 1997 – 2001
Plant Manager – Mr. K. H. Tseng– B.E. in Chemical Engineering
– Pharmaceutical Manufacturing since 1976
Management Team
8
Management Team (cont.)
Biotech R&D Lab Director – Dr. Alex Mai– Ph.D. Chemistry, National Taiwan University
– API R&D since 1994
Synthesis R&D Lab Director – Dr. Kevin Lee– Ph.D. Chemistry, National Tsing Hua University
– API R&D since 1994
Analytical R&D Lab Deputy Director – Dr. Ping-Shu Chen– Ph.D. Chemistry, National Sun Yat-sen University
– API R&D since 1997
9
Management Team (cont.)
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
Chief Operation Officer, Pharmaports – Mr. Joseph Chen– Master, National Yang-Ming University, Taipei, Taiwan – Manager, Global business 2006 – 2016– Sales Specialist, Merck Display Tech. Ltd., Taiwan 2005 – 2006– Account Manager and Marketing Specialist, Everlight Chemical Indl.
Corp., Taipei 2002 - 2005
10
Management Team (cont.)
Production Technology Lab Deputy Director – Dr. Yen-Shih Tung– Ph.D. Chemistry, National Tsing Hua University
– API R&D since 2007-2015
– Production Technology since 2016
Projects Management Office Deputy Manger – Dr. Ting-Huei Lee– Ph.D. Chemistry, University of Sussex, UK
– API R& D since 2005
11
CCSB Organization Chart
PresidentDr. Chih-Ping Yang
The BoardChairman
Mr. Derek WangThe Auditor
Mr. Jacky Hong
Engineering Div.Mr. G. F. Tsai
Production Div.
President Office
R&D Div.Dr. Alex Mai
(Acting)
Business Div.Mr. Chuan Wen Chen
Administration Div.Mr. Denry Huang
PharmaportsMr. Joseph
Chen
12
Research and Development
13
R & D Manpower
Synthesis Biotech Analytical Total %
Ph.D. 6 5 2 13 25.49%
Master 10 8 8 26 50.98%
Bachelor 4 2 3 9 17.64%
Others 1 2 0 3 5.88%
Total 21 17 13 51
14
Biotech Capabilities
Strain ImprovementObtain high producer strain through screening and mutation
Fermentation Process Development & Commercialization
Pravastatin Sodium; Rapamycin (Sirolimus); Mycophenolate Mofetil; Tacrolimus(FK506);Caspofungin; Temsirolimus; Everolimus; Biolimus; Zotarolimus
15
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
16
Official cGMP InspectionsYear Authorities Nation Product2002 FDA US Methocarbamol
2005 FDA US Pravastatin
2007 KFDA Korea Methocarbamol
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
2014 FDA US Full Products
2015 Koln Germany Pravastatin Sodium; Tacrolimus
2015 TFDA Taiwan Full Products
2015 Cofepris Mexico Caspofungin
17
Active US DMF List
DMF 26271Ethyl lcosapentate
DMF 26819Everolimus Pre-Mix
DMF 27216Everolimus
DMF 27585Caspofungin Acetate
DMF 30103Omega-3-Varboxylic Acids
DMF 31189Rapamycin (Sirolimus)
DMF 31276Carfilzomib
DMF 13080Methocarbamol
DMF 14234Guaifenesin
DMF 14235Pravastatin Sodium
DMF 17399Rapamycin
DMF 17573Trandolapril
DMF 18494Mycophenolate Mofetil
DMF 18985Tacrolimus
DMF 22430Olopatadine HCl
DMF 23213Tacrolimus SD20
DMF 23434Metaxalone
DMF 23435Mycophenolate Sodium
DMF 24372Mycophenolate Mofetil HCl
18
Equipment for Synthesis
Glass-lined Reactors: Total Volume 24,000 L
Stainless 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
19
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
20
Equipment for Analytical
Analytical
GC/MS
LC/MS
UPLC
X-ray Powder
Diffraction
GC
HPLC
216 inch MPLC system
2 inch and 3 inch HPLC column
Instrumentation
22
Waters preparative HPLC system 2 inch DAC column
Instrumentation (cont.)
23
Instrumentation (cont.)
Powder X-Ray Diffraction
HPLC
GC
LC Mass
UPLC
24
Instrumentation (cont.)
GC/MS
25
Instrumentation (cont.)
GE AKTA Purifier UPC 100
BioTek Synergy H1 Hybrid Reader
KvickLab Cross
Flow System
26
Instrumentation (cont.)
Pyros Kinetix Flex Automatic Endotoxin Detection System
GEA Niro High Pressure Homogenizer
27
Instrumentation (cont.)
Mbraun Glove box
Type: UNILAB-BBio Rad ChemiDoc XRS+ Imaging System
28
Location & Buildings
CCSB
Taoyuan Int’l Airport
Located in Shu-Lin,New Taipei City
20 km South West of Taipei
34,000 m2
273 Employees
As of December 2017 Taipei Songshan Airport
29
CCSB Campus Layout
30
Chunghwa Chemical Synthesis & Biotech
31
cGMP Commercial Plants
cGMP Plants
32
Synthetic Pilot Plant
75 L Stainless Steel Reactor
50 L Glass Lined Reactor
50 L Cone Dryer & 25” Centrifuge
33Freeze Dryers
Synthetic Pilot Plant (cont.)
34
Synthetic Commercial Plants
3,000 L Glass Lined Reactors
35
Synthetic Commercial Plants (cont.)
Stainless Steel Reactors
Cone Dryer in Controlled Room
36
Biotech Pilot Plant
5 L Fermentor
600 L Fermentor
22 L Fermentor
37
Biotech Commercial Plant
ABEC 75L, 250L & 1250 L Bioreactors
ABEC 250LBioreactors
38
Biotech Commercial Plant (cont.)
Autoclave
Incubator & Shock Box
Biosafety Cabinet
39
Biotech Commercial Plant (cont.)
20,000 L & 30,000 L Fermentors
40
Biotech Commercial Plant (cont.)
5,000 L Glass-lined and Stainless SteelReactors for Purification Process
41
Biotech Commercial Plant (cont.)
Recovery & Purification Equipment Ultra Filtration
42
Whole Drug Life Cycle Support
Pre-clinical Phase I/II Phase III/Launch
Drug Life Time
grams kilograms tons/multi-tons
43
Summary of CCSB
Over 50 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