AMBIOPHARM, Inc. Peptide API Manufacturing and Services
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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
• Chris Bai, Ph.D. President & CEO 18 years in pharmaceutical manufacturing experience. Former president and CEO of American Peptide Company
• Jim Hampton, BS, MS, Exec VP of BD and Sales 18 years in pharmaceutical business development
• Ruoping Zhang, BS, VP of Manufacturing14 years in peptide API manufacturing experience.
• Robert Geiger, Ph.D. MBA. VP of Quality14 years in pharmaceutical QA/QC, business development
• Simrat Singh, Ph.D., Director of Analytical & QC8 years in Pharmaceutical product development
• Stephen Kiel, MBA, CPA, Chief Financial Officer35 years experience in financial management
Chris BaiChief Executive Officer
Jim HamptonExec VP of Bus Dev
Ruoping ZhangVP of Manufacturing
HR & Administration
Production
Robert GeigerVP of Quality
Quality ControlQA and Regulatory
US, EU, Canada, Asia
Sales reps
Proc Dev Director of Sales
Analytical Dev
Facilities Synthesis Downstream
Chemist Microbiologist Chemist Chemist Technician
Chemist QA Manager
AmbioPharm Manufacturing Sites
Non-Sterile API Peptide ManufacturingAmbioPharm, Inc.- World HQ in North Augusta, SC USA
Shanghai , China• NCEs Synthesis• Analytical Dev• R&D
North Augusta, SC• NCEs downstream
mfg• QC testing• QA release
Hainan, China• Generics Synthesis• Generics Downstream• Generics Final
product
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
60cm HPLC Column 400L Lyophilizer
Warehouse
Purification Capacity by 201528 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
Dedicated manufacturing line offers
further cost savings at larger scale.
1st to 3rd Floor of Building No. 131000L Solid Phase Reactors5000L Solution Phase Reactors
5th Floor of Building No. 134 Purification Suites20cm, 30cm, 45cm HPLC Purification Columns
2015 Synthesis Manufacturing Capacity200 kg crude/batch & 2,000 kg crude/year
30 solid phase reactors1L, 5L, 10L, 30L, 50L, 80L, 200L(up to 20kg crude/batch)
20 solution phase reactors10L, 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 solventsDMF, a major cost for peptide synthesis on large scaleUS Competitor’s cost: $3,500/tonAmbioPharm’s cost: $1,450/ton
• The solvent recovery system reduces the manufacturing cost further on larger scales
Manufacturing Cost Comparison
50 g 200 g 500 g 1000 g 2000 g 5000 g 10,000 g$0
$2,000,000
$4,000,000
$6,000,000
$8,000,000
$10,000,000
$12,000,000
Cost Comparison
US Competitor (Cost US$)
AmbioPharm (Cost US$)
Manufacturing Scale
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AmbioPharm, Inc.
Largest peptide manufacturing capacity; actively expanding capacity to meet specific customer needs
> 100 years management experience in cGMP
The highest technical capabilities in the peptide industry
Three manufacturing facilities to serve customers worldwide
Setting a new standard for the quality of APIs
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