CHEMPACIFIC CORPORATION   Contract Manufacturing of APIs,Intermediates and Specialty Chemicals
PRESENTATION OUTLINE   Company Overview   Unique Business Model   Chemistry and Technology   Facilities and Equipment...
COMPANY OVERVIEW   Began as a New Jersey Corporation in 1995   Moved to Baltimore, Maryland in 1999   >20 employees in ...
COMPANY OVERVIEW       ZheJiang ChemPacific Growth History                            2005                 2008           ...
COMPANY OVERVIEW                 Executive Team Chen Zhou, Ph.D. CEO     Ph.D. New Mexico State Univ.     Post Dr. Univer...
COMPANY OVERVIEW             Other Key Personnel Wuyi Wang, Ph.D. - Senior Director of cGMP  program, global Xianghui Ta...
COMPANY OVERVIEW   Core Business:           Research and Production of Fine Chemicals, Industrial            Chemicals, ...
COMPANY OVERVIEW   R&D Contract and Custom Synthesis:       Unique Projects for Hard to Find Molecules       High Level...
UNIQUE BUSINESS MODEL                      US Facility   Non-GMP and cGMP Manufacturing   Process Development   Lab Sca...
CHEMISTRY AND TECHNOLOGY HF and KF Fluorination Per-fluorinated Aromatics Suzuki Coupling Organics Organometallic/Oxyg...
CHEMISTRY AND TECHNOLOGY Synthetic organic chemistry expertise  • Non-patent-infringed process route development  • Exper...
Chemistry and TechnologyExample: Chemical Capability- Per-fluorinated AromaticsA. Per-fluorinated BenzeneB. Per-fluorinate...
CHEMISTRY AND TECHNOLOGY       Example: Chemical Capability- 2-bromo-indene                                              F...
CHEMISTRY AND TECHNOLOGYExample: Chemical Capability- Suzuki Coupling Organics1. RLi handling capability (Organometallic C...
FACILITIES AND EQUIPMENT              Manufacturing Plant in ChinaChemPacific Zhejiang: 11 Acre site (expandable to  18 a...
ZHEJIANG CHEMPACIFIC
ZHEJIANG CHEMPACIFIC    Zhejiang ChemPacific            Corp.                                           COO               ...
ZHEJIANG CHEMPACIFIC
ZHEJIANG CHEMPACIFICChemistry Capabilities:Synthesis Leads to ManufacturingCustom Synthesis    Specialty Chemical Synthes...
ZHEJIANG CHEMPACIFICChemistry Capabilities: Process Research and  ManufacturingProcess Research and Development    Novel ...
ZHEJIANG CHEMPACIFIC   RESEARCH to PROCESS DEVELOPMENT TO PRODUCTION                                  Zhapu (China)Process...
ZHEJIANG CHEMPACIFIC                  Competitive Advantage    Low Cost Supported by World-Class Quality   Raw Material S...
ZHEJIANG CHEMPACIFIC      Quality Platform and Systems     Quality Systems             Risk-based approach                ...
ZHEJIANG CHEMPACIFICEmployees: There are 145 employees in Zhapu, 45% have BS degree andabove.Hours of operation: 3 shifts ...
ZHEJIANG CHEMPACIFIC            Facilities and Equipment Zhapu,                China Manufacturing PlantZHEJIANG ChemPacif...
ZHEJIANG CHEMPACIFIC  Generic API-Case#1–Pentostatin                Name: Nipent /Pentostatin      OH        •Market: Ant...
ZHEJIANG CHEMPACIFICChina Production-Case#2             CO 2H                             Name: 3,4,5-TricarboxylicAcid-  ...
ZHEJIANG CHEMPACIFIC    China Production-Case#3       H    O                Name: p-(4-Formylcyclohexyl) BenzonitrileO    ...
ZHEJIANG CHEMPACIFICChina Production-Case#4Name: 2,3-Difluorophenylacetic AcidMarket: Specialty Electronic MaterialUS Rese...
ZHEJIANG CHEMPACIFICGeneric API –Case#5– Melphalan HCl                                               DMF No. 20544Market: ...
COMPETITIVE ADVANTAGEDomestic Presence    Convenience for U.S.     customers    Same time zone    No language barrier  ...
COMPETITIVE ADVANTAGE                        Experience Expertise in a wide range of chemistries Experienced in manufact...
ZHEJIANG CHEMPACIFIC
ZHEJIANG CHEMPACIFIC
ZHEJIANG CHEMPACIFIC
ZHEJIANG CHEMPACIFIC
ZHEJIANG CHEMPACIFIC
ZHEJIANG CHEMPACIFIC
ZHEJIANG CHEMPACIFIC
CHEMPACIFIC CORPORATION  Some call it the best of both worlds;        we call it, The Best of One World.For more informati...
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ChemPacific Presentation, Best of Both Worlds

  1. 1. CHEMPACIFIC CORPORATION Contract Manufacturing of APIs,Intermediates and Specialty Chemicals
  2. 2. PRESENTATION OUTLINE Company Overview Unique Business Model Chemistry and Technology Facilities and Equipment Zhejiang Chempacific Competitive Advantage Contact Information
  3. 3. COMPANY OVERVIEW Began as a New Jersey Corporation in 1995 Moved to Baltimore, Maryland in 1999 >20 employees in the U.S. operation 100% U.S. owned subsidiary in China • Zhejiang ChemPacific located near Shanghai • Staffed with over 100 employees
  4. 4. COMPANY OVERVIEW ZheJiang ChemPacific Growth History 2005 2008 2011 Started GMP Successful FDA Successful FDA Training Program Inspection Inspection 1998ChemPacific China Established in Hangzhou 2000-2004 2005-2006 Manufacture of China Operations >100 Custom Consolidation Products In Zhapu
  5. 5. COMPANY OVERVIEW Executive Team Chen Zhou, Ph.D. CEO Ph.D. New Mexico State Univ. Post Dr. University of Maine Tony Liang, MS, MBA - COO/China & US Operations, Sales Marketing Worked at Novartis Pharmaceuticals MBA New York Rebecca Chiu, MS - VP, Global QA/QC Worked at Pfizer 2.5 years Worked at Novartis Pharma 32.5 years
  6. 6. COMPANY OVERVIEW Other Key Personnel Wuyi Wang, Ph.D. - Senior Director of cGMP program, global Xianghui Tan, Ph.D. - US Director of cGMP Production Jian Huang, Ph.D. - CTO of China Operations James Havlin, MBA - VP of Sales and Marketing Peter Wu, PhD. - Head of QC, US Jinliang Zhang - General Manager, China Liping Gao, Ph.D - Head of QA/QC, China
  7. 7. COMPANY OVERVIEW Core Business:  Research and Production of Fine Chemicals, Industrial Chemicals, Intermediates and APIs Resources:  Research-driven U.S. Laboratories • Discover and develop products • Perform small scale cGMP/ Non-GMP manufacturing up to 50kg Cost-effective plants in China:  Large scale non-GMP/cGMP manufacturing up to 100 metric ton
  8. 8. COMPANY OVERVIEW R&D Contract and Custom Synthesis:  Unique Projects for Hard to Find Molecules  High Levels of Communications with Researcher  Tech Transfer to China for large scale production Custom Manufacturing/Intermediates:  Starting with Customer Process or Just a Structure  Process Development and Optimization performed in the US  Scale-Up to Commercial Quantities performed in China
  9. 9. UNIQUE BUSINESS MODEL US Facility Non-GMP and cGMP Manufacturing Process Development Lab Scale (up to 1kg) Kilo Lab (up to 5 kg) China Facility Non-GMP and cGMP Manufacturing Scale-Up Manufacturing Pilot Plant (5 kg to 1000kg) Commercial (1 MT to 100MT)
  10. 10. CHEMISTRY AND TECHNOLOGY HF and KF Fluorination Per-fluorinated Aromatics Suzuki Coupling Organics Organometallic/Oxygen Sensitive Chiral Synthesis Unnatural Amino Acids Indolines and Indoles Heterocyclic Synthesis
  11. 11. CHEMISTRY AND TECHNOLOGY Synthetic organic chemistry expertise • Non-patent-infringed process route development • Experience in handling a variety of chemistries with chiral and non-chiral compounds • Chemistry R&D and process validation • Modern Analytical facilities
  12. 12. Chemistry and TechnologyExample: Chemical Capability- Per-fluorinated AromaticsA. Per-fluorinated BenzeneB. Per-fluorinated NaphthaleneCommercial Scale
  13. 13. CHEMISTRY AND TECHNOLOGY Example: Chemical Capability- 2-bromo-indene Functionization of 2-Br-IndeneA. 2-Br-Indene Chemistry p-TSA Br Br -H2O OH Commercial ScaleB. Cyclopentadiene Chemistry Functionization Tetramethyl Cp Pentamethyl Cp
  14. 14. CHEMISTRY AND TECHNOLOGYExample: Chemical Capability- Suzuki Coupling Organics1. RLi handling capability (Organometallic Chemistry Expertise)2. Low temperature reaction and handling capabilities
  15. 15. FACILITIES AND EQUIPMENT Manufacturing Plant in ChinaChemPacific Zhejiang: 11 Acre site (expandable to 18 acres) Capable of Handling Complex Projects Compartmentalized structure gives us the capability to expand with customers’ market demands
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  17. 17. ZHEJIANG CHEMPACIFIC Zhejiang ChemPacific Corp. COO Global QA/QC Organization Chart Tony Liang Rebecca Chiu General Manager Jinliang Zhang Vice GM QA/QC Jian Huang Liping GaoProduction R&D ESH & Engineering Sales QA QC Materials Finance Administration Project Project Xiaokang Hu Marketing Jianguo Gao Xingju Wei Managers Jiuwang.liu Xiaoyan Xi Yan Ding Managers Huiling Zhu
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  19. 19. ZHEJIANG CHEMPACIFICChemistry Capabilities:Synthesis Leads to ManufacturingCustom Synthesis Specialty Chemical Synthesis and Scale-up Chemistry from 100 mg to Kilo+Manufacturing Scale-up Chemistry for Metric Ton Scale in China Resulting in Commercial Manufacturing
  20. 20. ZHEJIANG CHEMPACIFICChemistry Capabilities: Process Research and ManufacturingProcess Research and Development Novel Synthetic Route Selection Process Optimization and Scale upManufacturing of Specialty Chemicals and APIs cGMP Synthesis Kilo-Scale for Clinical Trials
  21. 21. ZHEJIANG CHEMPACIFIC RESEARCH to PROCESS DEVELOPMENT TO PRODUCTION Zhapu (China)Process Development and Scale up Cost Effective API Manufacturing Facility & Engineering Design API Stability Program
  22. 22. ZHEJIANG CHEMPACIFIC Competitive Advantage Low Cost Supported by World-Class Quality Raw Material Sourcing Partners Locally Produced Equipment and Infrastructure Plentiful Supply of Low Cost Labor Experienced R&D Chemists and Process Engineers Dedicated QC and QA teams Complies to cGMP/FDA Q7 Guildance
  23. 23. ZHEJIANG CHEMPACIFIC Quality Platform and Systems Quality Systems Risk-based approach Judgment based on good science Total Quality Assurance on entire business cycleChemPacific Quality Program Product Platform Chemistry and Technology Facilities and Equipment, FDA Inspected Facility Corporation structure support
  24. 24. ZHEJIANG CHEMPACIFICEmployees: There are 145 employees in Zhapu, 45% have BS degree andabove.Hours of operation: 3 shifts in production.Scheduled facility closures: weeks of Chinese New year, May 1 and Oct. 1. Office Support /Sales 20% 10% R&D 16% QA/QC Production 9% 44%
  25. 25. ZHEJIANG CHEMPACIFIC Facilities and Equipment Zhapu, China Manufacturing PlantZHEJIANG ChemPacific, Zhapu (Jan. 2006 in operation) Located in a Modern Industrial Park Reaction vessels Up to 5000L -78°C Reactor (300 L, 1000L and 2000L) Up to 1000 PSI H2 reactor (300L and 1000L) High Vacuum/Thin Film Distillation Particle Forming Spray Dryer Capability Large-Scale Column Chromatography Up to MT scale
  26. 26. ZHEJIANG CHEMPACIFIC Generic API-Case#1–Pentostatin Name: Nipent /Pentostatin OH •Market: Anti-tumor Pharmaceutical •Prior API Process: Fermentation N ChemPacific Process: Total Synthesis of 12 steps HN Zhapu: step 1 to step 6 (non-GMP) N Baltimore: step 7 to step 12 (GMP) N HO US Research-China Production: O China: Supply of Advanced Intermediate; Baltimore: API Manufacture/DMF Submission Summary: OH •ChemPacific Developed the First Chemical Process for API •ChemPacific Owns the Pentostatin Process Patent •US-China Synergy Made the Cost Manageable for thisDMF No. 18235 Complex Project
  27. 27. ZHEJIANG CHEMPACIFICChina Production-Case#2 CO 2H Name: 3,4,5-TricarboxylicAcid- HO2 C CO2 H 1-Aminobenzene Market: Specialty Electronic Material NH 2 15,000 kg/Y US Research-China Production: Baltimore: Process Development China: 3-step Custom Manufacture
  28. 28. ZHEJIANG CHEMPACIFIC China Production-Case#3 H O Name: p-(4-Formylcyclohexyl) BenzonitrileO Market: Specialty Electronic Material US Research-China Production:R Baltimore: Process Development China: 5-step Reaction Sequence for Single CN Customer 200 kg
  29. 29. ZHEJIANG CHEMPACIFICChina Production-Case#4Name: 2,3-Difluorophenylacetic AcidMarket: Specialty Electronic MaterialUS Research-China Production:Baltimore: Process DevelopmentChina: 3-step Reaction Sequence for aSingle Customer F F F F F OH O 1000 kg
  30. 30. ZHEJIANG CHEMPACIFICGeneric API –Case#5– Melphalan HCl DMF No. 20544Market: Anti-Cancer, Anti-Neoplastic,Pharmaceutical APIChemPacific Process: Total Synthesis of 8 steps 4 steps to starting material – made in Zhapu (non-GMP) from SM to the step 7 – made in Zhapu (GMP) last step – was in US (GMP) – has been transferred to China
  31. 31. COMPETITIVE ADVANTAGEDomestic Presence  Convenience for U.S. customers  Same time zone  No language barrier  Secure business practices  Troubleshooting handled locallySmall company  Personal attention  Flexibility  Quick delivery time  Low overhead- pass lower costs to our clients
  32. 32. COMPETITIVE ADVANTAGE Experience Expertise in a wide range of chemistries Experienced in manufacturing of hard to find molecules Experienced technical team who recognize the challenges of transitioning from bench to pre-scale operations. Reliable and Financially Stable A track record of completed projects and satisfied customers
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  40. 40. CHEMPACIFIC CORPORATION Some call it the best of both worlds; we call it, The Best of One World.For more information please contact Chris McRandal, cmcrandal@chempacific.com, (412) 973-9716

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