chempacific presentation, best of both worlds
Post on 19-Oct-2014
423 views
DESCRIPTION
TRANSCRIPT
CHEMPACIFIC CORPORATION
Contract Manufacturing of APIs,
Intermediates and Specialty Chemicals
PRESENTATION OUTLINE
Company Overview
Unique Business Model
Chemistry and Technology
Facilities and Equipment
Zhejiang Chempacific
Competitive Advantage
Contact Information
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
COMPANY OVERVIEW
ZheJiang ChemPacific Growth History
1998
ChemPacific China
Established in
Hangzhou
2000-2004
Manufacture of
>100 Custom
Products
2005-2006
China Operations
Consolidation
In Zhapu
2005
Started GMP
Training Program
2008
Successful FDA
Inspection
2011
Successful FDA
Inspection
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
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
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
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
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)
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
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
Chemistry and Technology
B. Per-fluorinated Naphthalene
Commercial Scale
Example: Chemical Capability- Per-fluorinated Aromatics
A. Per-fluorinated Benzene
CHEMISTRY AND TECHNOLOGY
Br
OH
Br-H2O
p-TSA
Functionization of 2-Br-Indene
Commercial Scale
B. Cyclopentadiene Chemistry
Tetramethyl Cp
Pentamethyl Cp
Functionization
Example: Chemical Capability- 2-bromo-indene
A. 2-Br-Indene Chemistry
CHEMISTRY AND TECHNOLOGY
1. RLi handling capability (Organometallic Chemistry Expertise)
2. Low temperature reaction and handling capabilities
Example: Chemical Capability- Suzuki Coupling Organics
FACILITIES AND EQUIPMENT
Manufacturing Plant in China
ChemPacific 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
ZHEJIANG CHEMPACIFIC
General Manager
Jinliang Zhang
COO
Tony Liang
Vice GM
Jian Huang
Global QA/QC
Rebecca Chiu
QA/QC
Liping Gao
R & D
Project
Managers
ESH & Engineering
Xiaokang Hu
Materials
Jiuwang.liu
Finance
Xiaoyan Xi
Sales
Marketing
Huiling Zhu
Administration
Yan Ding
QA
Jianguo Gao
QC
Xingju Wei
Zhejiang ChemPacific Corp.
Organization Chart
Production
Project
Managers
ZHEJIANG CHEMPACIFIC
ZHEJIANG CHEMPACIFIC
Chemistry Capabilities:
Synthesis Leads to Manufacturing
Custom 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
ZHEJIANG CHEMPACIFIC
Process Research and Development
Novel Synthetic Route Selection
Process Optimization and Scale up
Manufacturing of Specialty Chemicals and APIs
cGMP Synthesis
Kilo-Scale for Clinical Trials
Chemistry Capabilities: Process Research and
Manufacturing
ZHEJIANG CHEMPACIFIC
RESEARCH to PROCESS DEVELOPMENT TO PRODUCTION
Facility & Engineering Design
ZHEJIANG CHEMPACIFIC
Process Development and Scale up Cost Effective API Manufacturing
Zhapu (China)
API Stability Program
Competitive Advantage
Low Cost Supported by World-Class Quality
ZHEJIANG CHEMPACIFIC
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
Quality Platform and Systems
ChemPacific Quality Program
Platform Product
Quality Systems Risk-based approach
Judgment based on good science
Total Quality Assurance on entire business cycle
Chemistry and Technology
Facilities and Equipment,
FDA Inspected Facility
Corporation structure support
ZHEJIANG CHEMPACIFIC
Employees: There are 145 employees in Zhapu, 45% have BS degree and
above.
Hours of operation: 3 shifts in production.
Scheduled facility closures: weeks of Chinese New year, May 1 and Oct. 1.
Office
/Sales
10%
Production
44%
QA/QC
9%
R&D
16%
Support
20%
ZHEJIANG CHEMPACIFIC
Facilities and Equipment Zhapu,
China Manufacturing Plant
ZHEJIANG 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
ZHEJIANG CHEMPACIFIC
Generic API-Case#1–Pentostatin
NH
NN
N
OH
OOH
OH
DMF No. 18235
Name: Nipent /Pentostatin
•Market: Anti-tumor Pharmaceutical
•Prior API Process: Fermentation
ChemPacific Process: Total Synthesis of 12 steps
Zhapu: step 1 to step 6 (non-GMP)
Baltimore: step 7 to step 12 (GMP)
US Research-China Production: China: Supply of Advanced Intermediate;
Baltimore: API Manufacture/DMF Submission
Summary:
•ChemPacific Developed the First Chemical Process for API
•ChemPacific Owns the Pentostatin Process Patent
•US-China Synergy Made the Cost Manageable for this
Complex Project
ZHEJIANG CHEMPACIFIC
China Production-Case#2
Name: 3,4,5-TricarboxylicAcid-
1-Aminobenzene
Market: Specialty Electronic
Material
US Research-China Production:
Baltimore: Process Development
China: 3-step Custom Manufacture
15,000 kg/Y
CO2HHO2C
NH2
CO2H
ZHEJIANG CHEMPACIFIC
China Production-Case#3
Name: p-(4-Formylcyclohexyl) Benzonitrile
Market: Specialty Electronic Material
US Research-China Production:
Baltimore: Process Development
China: 5-step Reaction Sequence for Single
Customer
R
O
OH
CN
200 kg
ZHEJIANG CHEMPACIFIC
China Production-Case#4 Name: 2,3-Difluorophenylacetic Acid
Market: Specialty Electronic Material
US Research-China Production:
Baltimore: Process Development
China: 3-step Reaction Sequence for a
Single Customer
F
F OH
O
F
F F
1000 kg
ZHEJIANG CHEMPACIFIC
Generic API –Case#5– Melphalan HCl
DMF No. 20544
Market: Anti-Cancer, Anti-Neoplastic,
Pharmaceutical API
ChemPacific 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
ZHEJIANG CHEMPACIFIC
COMPETITIVE ADVANTAGE
Domestic Presence Convenience for U.S.
customers
Same time zone
No language barrier
Secure business practices
Troubleshooting handled locally
Small company Personal attention
Flexibility
Quick delivery time
Low overhead- pass lower costs to our clients
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
ZHEJIANG CHEMPACIFIC
ZHEJIANG CHEMPACIFIC
ZHEJIANG CHEMPACIFIC
ZHEJIANG CHEMPACIFIC
ZHEJIANG CHEMPACIFIC
ZHEJIANG CHEMPACIFIC
ZHEJIANG CHEMPACIFIC
Some call it the best of both worlds;
we call it, The Best of One World.
CHEMPACIFIC CORPORATION
For more information please contact Chris McRandal, [email protected], (412) 973-9716