Chunghwa Chemical Synthesis & Biotech Co., Ltd.
Introduction
of
Chunghwa Chemical Synthesis
& Biotech Co., Ltd.Nov. 2020
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
0
5,000
10,000
15,000
20,000
25,000
30,000
35,000
40,000
45,000
Domestic Export
Sales from 1998 to 2019
USD Thousands
4
0
5,000
10,000
15,000
20,000
25,000
30,000
35,000
Synthetic Products
Biotech Products
Contract Manufacturing
Sales from 1998 to 2019
USD Thousands
Americas47.3%
Domestic13.3%
Europe18.4%
Asia21.0%
Sales Area in 2019
5
6
Audit Office
The board Chairman
Admin. Center
Finance
Human Resources
Procurement
General Admin.
Information Technology
Sales Div.
Sales
Business
Development
Production
Div.
API production
EHS Dept.R&D Div.
Biotechnology
Research Lab
Synthesis
Research Lab
Analytical
R&D Lab
Production Technology
Project Management
Regulatory and QA Dept.
Pharmaports
President
President Office
CCSB Organization Chart
Management Team
Name Title Education Experience
Denry Huang President Bachelor, Chemical Engineering,Chung Yuan Christian University
API industry since 1977
K. H. TsengVP,Production Division
B.E. in Chemical EngineeringNational Cheng Kung University
Pharmaceutical Manufacturing since 1976
Patrick Wei
VP,Research & Development Division
Ph.D., Chemistry,National Tsing Hua University
VP of Research & Development Formosa Laboratories, Inc.
Joseph ChenVP, Sales Division
Master, Microbiology & Immunology,National Yang-Ming University
Chief Operating Officer, Pharmaports LLC2016-2019 Manager, Global business,CCSB 2006 – 2016
7
Management Team (cont.)
Name Title Education Experience
W. P. WangAVP,Regulatory and QualityAffairs Dept.
Ph.D. Ch.E.,University of Massachusetts
API R&D, Production and QA/QC since 1995
Alex MaiAVP,Biotechnology Research Lab.
Ph.D. Chemistry,National Taiwan University
API R&D since 1994
Jacky HongAVP, Audit Office
MBA,Chung Yuan Christian University
Audit Manager since 2003IT Manager, Albatron Technology Co., Ltd.
Y. L. HsuDirector,Synthesis Research Lab.
Bachelor, Chemical Engineering,Chung Yuan Christian University
API R&D since 1986
Eason Wang Director,Finance Dept.
MA in Accounting, Chinese Culture University
MAX ZIPPER CO.,LTD.Finance Manager
Ching-MingTien
Plant Manager,Production Division
Bachelor, Food science and Biotechnology,Da-Yeh University
Pharmaceutical Manufacturing since 1995
P. S. ChenDeputy Director,Analytical R&D Lab.
Ph.D.,National Sun Yat-Sen University
API R&D since 1997
8
Manpower
9
Regulatory Sales R&D Production Adminstration
Production (52 %)
Regulatory (12 %)
R&D(23 %)
Administration(9 %)
Sales (4 %)
Effective Apr. 30, 2020
27%
35%
32%
2%
15%
6%
1%
Effective Apr. 30, 2020
5%
10
CCSB R&D team
Doctoral degree
Master’s degree
Bachelor’s degree
Others (Inc. associate’s degree,
college)
Education attainment
Research & Development
Synthesis
Process Research
Process Improvement
Biotechnology
Strain Improvement
Fermentation Process Development
Purification Process Development
Purification Process Development
Analytical
Method Development
Analytical Method Validation
Specification Set Up
Project Mgmt
Peptide & Protein Process Development
Standard Preparation
Stability Study
ProductionTechnology Lab
Peptide & Protein Process DevelopmentPeptide & Protein Process Development
Pilot ( Scale- up ) Pilot ( Scale- up )
Trouble shooting
Pilot ( Scale- up )
Research and Development
12
Biotech Capabilities
Strain Improvement
Obtain high producer strain through screening and mutation
Fermentation Process Development & Commercialization
Pravastatin Sodium; Rapamycin (Sirolimus);
Mycophenolate Mofetil; Tacrolimus(FK506);
Caspofungin; Temsirolimus; Everolimus;
Biolimus; Zotarolimus
13
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
14
Year Authorities Nation Product
2002 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
2017 USFDA USA EPAE
2017 TFDA Taiwan CDMO Products
2017 PMDA Japan Rapamycin
2018 USFDA Taiwan Full Products
2019 ANSM France Methocarbamol
Official cGMP Inspections
15
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
16
Equipment for Synthesis
Glass-lined Reactors: Total Volume 24,000 L
Stainless Steel Reactors: Total Volume 140,000 L
Hot-Air Tray Dryers
Vacuum Tray Dryers
Double-cone Dryers
Hammer Mill
Fitz Mill
Jet Mill
Hastelloy Centrifuges
Stainless Steel Centrifuges
Dryers
Reactors
SynthesisCentrifuges
Mills
17
Equipment for Biotech
1,250 L – 30,000 L Fermentors
Total 137,000 L Fermentation Volume
Filter Press
Disk Centrifuge
Columns
Ultra-filtration
Preparative HPLCLyophilizer
Lyophilization
Biotech
Fermentation
Purification
18
Equipment for Analytical
Analytical
GC/MS
LC/MS
UPLC
X-ray
Powder
Diffraction
GC
HPLC
196 inch MPLC system
2 inch and 3 inch HPLC column
Instrumentation
20
Waters preparative HPLC system 2 inch DAC column
Instrumentation (cont.)
21
Instrumentation (cont.)
HPLC GC
LC Mass
UPLC
22
Instrumentation (cont.)
GC/MS
23
Instrumentation (cont.)
GE AKTA Purifier UPC 100
BioTek Synergy H1 Hybrid Reader
KvickLab Cross
Flow System
24
Instrumentation (cont.)
Pyros Kinetix Flex Automatic
Endotoxin Detection SystemGEA Niro High Pressure Homogenizer
25
Instrumentation (cont.)
Mbraun Glove box
Type: UNILAB-BBio Rad ChemiDoc XRS+ Imaging System
26
Location & Buildings
CCSB
Taoyuan Int’l Airport
Located in Shu-Lin,
New Taipei City
20 km South West of Taipei
34,000 m2
261 Employees
Taipei Songshan Airport
27
Chunghwa Chemical Synthesis & Biotech
28
CCSB Campus Layout
29
cGMP Commercial Plants
cGMP Plants
30
Synthetic Pilot Plant
75 L Stainless Steel Reactor
50 L Glass Lined Reactor
50 L Cone Dryer & 25” Centrifuge
31
Freeze Dryers
Synthetic Pilot Plant (cont.)
32
Synthetic Commercial Plants
3,000 L Glass Lined Reactors
33
Synthetic Commercial Plants (cont.)
Stainless Steel Reactors
Cone Dryer in Controlled Room
34
Biotech Pilot Plant
5 L Fermentor
600 L Fermentor
22 L Fermentor
35
Biotech Commercial Plant
ABEC 75L, 250L & 1250 L Bioreactors
ABEC 250LBioreactors
36
Biotech Commercial Plant (cont.)
Autoclave
Incubator & Shock
Box
Biosafety Cabinet
37
Biotech Commercial Plant (cont.)
20,000 L & 30,000 L Fermentors
38
Biotech Commercial Plant (cont.)
5,000 L Glass-lined and Stainless Steel
Reactors for Purification Process
39
Biotech Commercial Plant (cont.)
Recovery & Purification Equipment Ultra Filtration
40
grams
kilograms
ton/ multi-tons
Pre-clinical
Phase I/II
Phase III/Launch
Whole Drug Life Cycle Support
41
Summary of CCSB
Over 55 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