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AMBIOPHARM, Inc.
Supplier of Peptide API
Manufacturing and Services
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Ambio Locations and History
• AmbioPharm registered in US
AmbioPharm USA
2006
2015
2007
2013
• Shanghai AmbioPharm built new commercial manufacturing
facility:
Chemspec AmbioPharm, Shanghai
• North Augusta expansion Building 400
• North Augusta expansion Building 500 & Shanghai
expansion
• AmbioPharm acquired UCB Bioproducts at North Augusta, SC
• Shanghai AmbioPharm, started at Shanghai, China
• PAI Inspections
Shanghai AmbioPharm
Chemspec AmbioPharm
• PAI Inspections
2017
2019
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Ambio Holdings Structure
Ambio Holdings
(A Delaware Company)
AmbioPharm, Inc.Non-Sterile APIs
North Augusta, SC
Peptide API Development & Manufacturing
North Augusta, SC, USA
Shanghai, China
Peptide API Development & Manufacturing
Shanghai, China
• Hours: 8-5pm; Manufacturing 24 hours,
7 days a week
• Employees: 150
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Peptide Manufacturing Business
More than 100 customer projects, pre-clinical to
commercial stage
Partner for both novel (NCE) and generic
peptide APis
Peptide
Manufacturing
Superior chemistry and facilities in both the US and China
enable best-in-class quality and low
cost of production
Solid-phase, solution-phase and/or hybrid peptide chemistry
Both facilities are FDA approved
Largest peptide manufacturing capacity;
actively expanding capacity
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Process Development, cGMP Pilot, and
Large-Scale API Manufacturing Facilities
Shanghai-AmbioPharm
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Manufacturing Facility Expansion
30,000 sf at Shanghai completed in 2015
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Synthesis Manufacturing Capacity
200 kg crude/batch & 2000 kg crude/year
➢ Solid phase reactors (multiple)
1L, 5L, 10L, 30L, 50L, 80L, 200L
(up to 20 kg crude/batch)
➢ Solution phase reactors (multiple)
10L, 20L, 30L, 50L, 80L, 200L
(up to 40kg crude/batch)
➢ 1000L Solid Phase Reactor
(up to 100 kg crude/batch)
➢ 5000L Solution Phase Reactor
(up to 200 kg crude/batch)
➢ Commercial building in Shanghai
has 4 additional manufacturing
lines
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Peptide API Manufacturing
Purification Scale From 1g to 30 kg/batch Final Peptide
Preparative HPLC columns:
➢ ID: 5, 8, 15, 20 and 30cm
(up to 7kg/batch and 100kg/year)
➢ ID: 45cm HPLC Column
(up to 15 kg/batch and 120 kg/year)
➢ ID: 60cm HPLC Column
(up to 28 kg/batch and 200 kg/year)
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Peptide API Manufacturing
Freeze Drying Capacity
➢ Four (4) Manifold lyophilizers
(up to 1 kg/batch and 50 kg/year)
➢ 100L tray lyophilizer
(up to 1 kg/batch and 50kg/year)
➢ 200L tray lyophilizer
(up to 3 kg/batch and 150kg/year)
➢ 400L tray lyophilizer
(up to 6 kg/batch and 300kg/year)
➢ 800L tray lyophilizer
(up to 12 kg/batch and 600kg/year)
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Final Product Released in USA
Quality Control Laboratory
➢ HPLC
➢ UPLC
➢ GC
➢ LC/MS
➢ IC
➢ SEC
➢ KF
➢ Peptide Content
➢ Amino acid analysis
➢ Endotoxin and Bioburden
➢ MS-MS Sequencing and NMR
(3rd Party)
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AmbioPharm, North Augusta, SC
Non-Sterile Peptide API Development and Manufacturing
June 2017
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North Augusta Facility Expansion 2019
Building 500
➢ 55,000 ft2
➢ New Manufacturing Suites
➢ New QC and Micro Labs
➢ Coming on line in Late 3rd Quarter-2019
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Shanghai New Campus 2020
13
Three Buildings with more than 55,000 m2
adding new:
➢ Administration offices➢ QC Laboratory➢ Pilot Production➢
R&D Laboratories➢ Commercial Lines
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Shanghai Expansion Plan
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15
AmbioPharm, Inc.
◼ Actively expanding capacity to meet specific customer
needs
◼ 130+ years management experience in cGMP
◼ 4 commercial products being made at AmbioPharm
◼ Two manufacturing facilities to serve customers worldwide
