Transcript AmbioPharm History

AMBIOPHARM, Inc.
Peptide API Manufacturing and Services
AmbioPharm History
• AmbioPharm, registered in California, USA in 2005
• AmbioPharm, acquired UCB Bioproducts at North Augusta, SC in 2007
• Shanghai AmbioPharm, started at Shanghai, China in 2007
• Chemspec and AmbioPharm Joint Venture Facility, Shanghai, China in 2014
AmbioPharm USA
Shanghai AmbioPharm
Chemspec AmbioPharm
Compliance & Inspection History
– November 2008, FDA audit of USA site: no 483 observations
– August 2011, FDA audit of USA site: no 483 observations
– October 2011, sFDA audit of Shanghai site: no observations
– March 2013, FDA PAI of USA site: 4 “483” observations
– August 2013, FDA PAI of Hainan site: 3 “483” observations
– August 2013, FDA PAI of Shanghai site: 2 “483” observations
– August 2014, FDA approved Shanghai AmbioPharm (EIR Letter)
– October 2014, FDA PAI of US site: 1 ‘483’ observation
– November 2014, FDA approved AmbioPharm US site (FDA Letter)
Seasoned Management Team
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Chris Bai, Ph.D. President & CEO
18 years in pharmaceutical manufacturing experience.
Former president and CEO of American Peptide Company
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Jim Hampton, BS, MS, Exec VP of BD and Sales
18 years in pharmaceutical business development
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Ruoping Zhang, BS, VP of Manufacturing
14 years in peptide API manufacturing experience.
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Robert Geiger, Ph.D. MBA. VP of Quality
14 years in pharmaceutical QA/QC, business development
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Simrat Singh, Ph.D., Director of Analytical & QC
8 years in Pharmaceutical product development
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Stephen Kiel, MBA, CPA, Chief Financial Officer
35 years experience in financial management
Chris Bai
Chief Executive Officer
Robert Geiger
VP of Quality
HR & Administration
Ruoping Zhang
VP of Manufacturing
Proc Dev
QA and Regulatory
Quality Control
Chemist
Microbiologist
Production
Director of Sales
Analytical Dev
Facilities
QA Manager
Jim Hampton
Exec VP of Bus Dev
Chemist
Technician
Synthesis
Chemist
Downstream
Chemist
US, EU, Canada, Asia
Sales reps
AmbioPharm Manufacturing Sites
AmbioPharm, N. Augusta, SC USA
• 32 acres acquired from UCB Pharma in 2006
• Existing cGMP/Process Development facility on 2 acres
Expansion of North Augusta Manufacturing Facility
Warehouse
60cm HPLC Column
400L Lyophilizer
Purification Capacity by 2015
28 kg/batch and 300 kg/year
Non-Sterile Peptide API Manufacturing
Purification Scale from 1 gram up to
30 kg/batch Final Peptide
Preparative HPLC columns:
 ID: 5, 8, 15, 20 and 30cm (up to
7kg/batch)
 ID: 45cm (up to 15 kg/batch)
 ID: 60cm (up to 28 kg/batch)
Non-Sterile Peptide API Manufacturing
Freeze Drying Capacity
 Four (4) Manifold lyophilizers (up to
1kg/batch)
 100L tray lyophilizer to be installed by
Q4 2014 (up to 7 kg/batch)
 200L tray lyophilizer (up to 15 kg/batch)
 400L tray lyophilizer (up to 30 kg/batch)
Phase II Expansion- Q3 2015
Tank Farm for Additional Solvent Capacity
Annex to House 60cm Column Water System & Future Expansion Area
AmbioPharm Facilities - Shanghai Campus
Process Development, cGMP Pilot, and
Large-Scale API Manufacturing Facilities
Manufacturing Expansion of 30,000 ft2
Completed at Shanghai Facility
1st to 3rd Floor of Building No. 13
1000L Solid Phase Reactors
5000L Solution Phase Reactors
5th Floor of Building No. 13
4 Purification Suites
20cm, 30cm, 45cm HPLC Purification Columns
2015 Synthesis Manufacturing Capacity
200 kg crude/batch & 2,000 kg crude/year
 30 solid phase reactors
1L, 5L, 10L, 30L, 50L, 80L, 200L
(up to 20kg crude/batch)
 20 solution phase reactors
10L, 20L, 30L, 50L, 80L, 200L
(up to 40kg crude/batch)
 New 1,000L Solid Phase Reactor
(up to 100kg crude/batch
 New 5,000L Solution Phase Reactor
(up to 200kg crude/batch)
Final Product Release
Quality Control Laboratory
 HPLC (12)
 GC (2)
 LC/MS (2)
 IC
 SEC
 Amino acid analysis
 UPLC
 KF
 Endotoxin and Bioburden
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AmbioPharm’s Advantage
– Low Cost of Manufacturing
• Close to all the major raw material manufacturing
companies (amino acid derivatives and solvents)
• Low cost to manufacture under fully controlled cGMP
quality system and experienced management team
• Low cost on solvents
DMF, a major cost for peptide synthesis on large scale
US Competitor’s cost: $3,500/ton
AmbioPharm’s cost:
$1,450/ton
• The solvent recovery system reduces the
manufacturing cost further on larger scales
Manufacturing Cost Comparison
Cost Comparison
$12,000,000
$10,000,000
$8,000,000
US Competitor (Cost US$)
$6,000,000
AmbioPharm (Cost US$)
$4,000,000
$2,000,000
$0
50 g
200 g
500 g
1000 g
2000 g
Manufacturing Scale
5000 g
10,000 g
AmbioPharm, Inc.
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> 100 years management experience in cGMP
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The highest technical capabilities in the peptide industry
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Largest peptide manufacturing capacity; actively
expanding capacity to meet specific customer needs
Three manufacturing facilities to serve customers
worldwide
Setting a new standard for the quality of APIs