Introduction of Chunghwa Chemical Synthesis & Biotech Co., - - PowerPoint PPT Presentation

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Introduction of Chunghwa Chemical Synthesis & Biotech Co., - - PowerPoint PPT Presentation

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Introduction of Chunghwa Chemical Synthesis & Biotech Co., Ltd. Chunghwa Chemical Synthesis & Biotech Co., Ltd. Brief History of CCSB Profile Founded in 1964 First registered and one of the largest bulk pharmaceutical

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Chunghwa Chemical Synthesis & Biotech Co., Ltd.

Introduction

  • f

Chunghwa Chemical Synthesis & Biotech Co., Ltd.

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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

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Brief History of CCSB

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Sales from 2004 to 2016

USD Thousands

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

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Sales from 1998 to 2016

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

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5 Americas 53.03% Americas 53.03% Domestic 8.22% Domestic 8.22% Europe 7.9% Europe 7.9% Asia 30.79% Asia 30.79%

Sales Area in 2016

ROW 0.06% ROW 0.06%

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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

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  • 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

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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

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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

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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

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CCSB Organization Chart

President

  • Dr. Chih-Ping Yang

The Board Chairman

  • Mr. Derek Wang

The 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

Pharmaports

  • Mr. Joseph

Chen

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Research and Development

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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 3 5.88% Total 21 17 13 51

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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

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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 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

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Active US DMF List

  • DMF 26271

Ethyl lcosapentate

  • DMF 26819

Everolimus Pre-Mix

  • DMF 27216

Everolimus

  • DMF 27585

Caspofungin Acetate

  • DMF 30103

Omega-3-Varboxylic Acids

  • DMF 31189

Rapamycin (Sirolimus)

  • DMF 31276

Carfilzomib

  • DMF 13080

Methocarbamol

  • DMF 14234

Guaifenesin

  • DMF 14235

Pravastatin Sodium

  • DMF 17399

Rapamycin

  • DMF 17573

Trandolapril

  • DMF 18494

Mycophenolate Mofetil

  • DMF 18985

Tacrolimus

  • DMF 22430

Olopatadine HCl

  • DMF 23213

Tacrolimus SD20

  • DMF 23434

Metaxalone

  • DMF 23435

Mycophenolate Sodium

  • DMF 24372

Mycophenolate Mofetil HCl

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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

Synthesis

Centrifuges Mills

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Equipment for Biotech

1,250 L – 30,000 L Fermentors Total 137,000 L Fermentation Volume Filter Press Disk Centrifuge Columns Ultra-filtration Preparative HPLC Lyophilizer

Lyophilization

Biotech

Fermentation Purification

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Equipment for Analytical

Analytical

GC/MS LC/MS UPLC X-ray Powder Diffraction GC HPLC

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6 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 X-Ray Diffraction HPLC GC

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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-B Bio 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
  • 273 Employees

As of December 2017

Taipei 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

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Freeze 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.)

Autoclave Incubator & Shock Box Biosafety Cabinet

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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 Steel Reactors 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 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