presentation jan 2011 new
DESCRIPTION
ChemPacific CorporationTRANSCRIPT
Custom Manufacturing Capabilities for
Specialty Chemicals and APIs
ChemPacific Business Model: From USA Research
to Production in China
Some call it the best of both worlds,
we call it, The Best of One World.
A Maryland Corp.---Growth History
1995founded
in
NJ, USA
1999
ChemPacific China
Operation in
HangZhou
1999
Moved to
Baltimore
MD, USA
2002
Baltimore Site
Successful FDA
Inspection
2005
Baltimore Site
Successful FDA
Inspection
2007
3rd Successful FDA
Inspection
10 DMFs
2000-2004
Manufacture
of >
100 custom
products
2008 - 2010
China Operations
FDA Inspected
100 employees
2005
US-China
Quality
Transfer
ChemPacific Offers
R&D- Contract and Custom
Lab Work Done in USA & China
Custom Manufacturing
Process Development and
Scale-Up
R&D Contract and CustomUnique Projects for Hard to Find Molecules
High Levels and Effective Communications with Researchers
CDAs Processed Quickly
Secure Protection of IP
Highly Effective Production Capability with IP Security
FTE Capability in US and/or China
Custom ManufacturingStarting with Customer Process or Just a Structure
We Perform Process Development Beyond the Package Given
Development Work Mainly Done in US
APIs Currently In Production in US (15 DMFs)
Scale-Up to Commercial Quantities in our 100%-Owned China Facility
Low Cost, High quality, reliability and IP Security
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
Large-Scale Manufacturing in China
Chemistry Capabilities: Process Research
and Manufacturing
UNIQUE BUSINESS MODEL
From US Research to China Production
US Facility
Process
Research
Small Scale
Production up
to 50kgs
China Facility
Cost Effective
Production/Scale
up to to 100 mt
Leveraging Manufacturing Excellence in China
Raw Material Sourcing Partners
Access to Low Cost Labor and large pool of highly educated talents
Effective Management of IP Security/Position
US Quality and Systems
Management Backgrounds Include Pharma Industry
Exceptional Experience Meeting FDA Regulations
Effective Management of Confidentiality/IP Security
Reputable US-Based Corporation Offering Stability, Consistency
and Reliability
Competitive AdvantageValue to our customers- Low Cost with Superb Product Quality
Specialty Chemicals- R&D & Manufacturing Excellence
A. Staffed R&D Organic and Organometallic expertise
- Organic Synthesis expertise leverages with our pharmaceutical total
synthesis capabilities, strength and experience
- Various Reactor sizes from R&D to kilo-lab and commercial-scale reactors
- Newly added Organometallic expertise to expand our services and product
offering to specialty chemicals industry
- Offering High Quality Products is our major strength and core value
- Speed, Consistency/Reliability and Cost Effectiveness are the value we
provide to our customers
B. Academic Reach and Collaboration
- Collaboration programs with major Universities in the USA and in China
Specialty Chemical Capability- Per-fluorinated Aromatics
A. Per-fluorinated Benzene
B. Per-fluorinated Naphthalene
Octachloro
NaphthaleneOctafluoro Naphthalene
Specialty Chemical Capability- 2-bromo-indene
Functionization of 2-Br-Indene
Br
OH
Br-H2O
p-TSA
Commercial Scale
2-R-Indene2-Br-Indene
ChemPacific Products-
2-Br-Indene2-R-Indene
Requirement- Organometallic Chemistry Expertise
Specialty Chemical Capability- Suzuki Coupling Organics
1. RLi handling capability (Organometallic Chemistry Expertise)
2. Low temperature reaction and handling capabilities
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
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
Norepinephrine Bitartrate
Generic API-Case#2-Norepinephrine Bitartrate
Name: Norepinephrine Bitartrate
Market: Anti-Epileptic Pharmaceutical
ChemPacific Process: Improved Process
US Research-China Production:China: Supply of GMP Advanced Intermediate
Baltimore: API Manufacture/ DMF submission
Summary:
•US Sole Producer
•US’s First DMF of the cGMP process
•China’s Low Cost Sourcing Coupled with US Expertise Made
this an Economic Success
China Production-Case#3
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
China Production-Case#4
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
China Production-Case#5Name: 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
Baltimore, USA OperationFDA Inspected Lab & Kilo-Scale Production
Total Staff of 35 including 12 Ph.D s
North America Technical Center
Global Headquarters
• 12,000 square foot laboratory space
• 50 L Glass reaction vessel
• 2 L Parr reactors, pressure vessels up to 2000 PSI
• Example of Analytical Instruments
» GC
» GC-MS
» IR, UV/VIS
» NMR
» Polarimeter
» HPLC
» LC-MS
» Prep HPLC
Facilities and Equipment
--R & D Lab Baltimore, MD
China OperationZhejiang ChemPacific at Zhapu
100% Subsidiary of US ChemPacific
Over 100 Employees
Facilities and Equipment Zhapu, China Manufacturing
Plant
ChemPacific Zhapu (2005)
Located in a Modern Industrial Park
11 Acre Site (Expandable to 18 Acres)
Capable of Handling Complex Projects
Multi-Purpose Equipment Up to 5000 L
-78°C Reactor (300 L)
Up to 1000 PSI H2 reactor (300 L)
High Vacuum/Thin Film Distillation
Large-Scale Column Chromatography
Up to 100 MT scale
Management TeamRebecca Chiu
CEO/President/QA
MS Pfizer
Novartis
Chen Zhou
COO/US Op
Ph.D. U. Of Maine
Tony Liang
VP/US Op/China Op
MBA
MS
Novartis
Warren Wang
Senior Director
Global QC/QA
Ph.D. Shire
Pharmaceuticals
James Havlin
VP/Sales
MBA E. Kodak
Mallinckrodt
Peter Wu
Dir. QC
Ph.D. UMBC
Maureen Zhang
Sales Manager
MBA Copeland Refrigeration
Emerson Electric
SUMMARY
Low-Cost Manufacturing in ChinaRaw Material Sourcing with Controls
Efficient Asset Infrastructure
Continued Low-Cost Labor Structure
US-Based Corporate Quality & Systems
IP Security and FDA/cGMP Experience
Proven Track RecordOver 1000 Lab-Scale Projects and Over 100 Large-Scale Projects PerformedSeamless Technology TransfersCapable of Total Product Development
Some call it the best of both worlds;
we call it, The Best of One World.
CHEMPACIFIC
6200 Freeport Centre
Baltimore, MD 21224
PH 410.633.5771
FX 410.633.5808
www.chempacific.com