Transcript Ambiopharm

AMBIOPHARM, Inc.
Biopharmaceutical
Manufacturing and Services
AmbioPharm’s Mission
Ambiopharm develops and
provides contract manufacturing
services for peptides and
biopharmaceuticals at clinical and
commercial scale
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AmbioPharm, Inc.
API Development Services
FROM CLINICAL TO COMMERCIAL
Preclinical
Phase I
Phase II
Phase III
NDA
Process Development
Analytical
Development
Analytical
Qualification
Analytical
Validation
Supportive Stability Studies
Scale-up
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Process Qualification
Process Validation
AmbioPharm N. Augusta, SC USA
• 32 acre site acquired from UCB Bioproducts in 2006
• 20,000 sq. ft. cGMP and process development areas
AmbioPharm, USA
Two Acres in Current Footprint
AmbioPharm’s HVAC Systems & Utilities
at Augusta
• GMP HVAC systems
 HEPA Filters
 Temperature and Humidity
Controls
 Pressure Differential
• Utilities
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Vacuum
Nitrogen supply
Chilled glycol
RO/USP water
City water
Compressed air
AmbioPharm’s Water System
at Augusta
• Purified - RO/USP Water
System (700 gallon)
 Meets USP Specification
 Purification
 Glassware washing
 Downstream Processing
Lab
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AmbioPharm’s Downstream Processing
at Augusta
• Purification scale from grams
to 10kg per batch
 Preparative HPLC systems
 Preparative HPLC columns,
 Lyophilizers
 Analytical HPLC systems
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AmbioPharm’s Freeze-Drying
at Augusta
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Freeze drying capacity from
gram to 20kg per batch
 Manifold lyophilizers
 Tray lyophilizers
 Largest dedicated peptide
lyophilizer in US
 Isolator for packaging API
AmbioPharm’s Quality Control
at Augusta
• Quality Control Laboratory
 HPLC
 GC
 LC/MS
 AAA
 pH Meter
 Peptide Sequencer
 KF
 Endotoxin and
Bioburden test equipment
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AmbioPharm’s Quality Control
at Augusta
• Cleaning and Drying Area
 Automatic Glassware
washer
 Depyrogenation Oven
 Steam Autoclave
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AmbioPharm Facilities
at Shanghai Campus
Process Development
Building One, Shanghai Campus
• Process Development Labs
Analytical HPLC systems
Preparative HPLC systems
Scale-up reactors
Fume hoods
Site and building security
Staffed with process chemists
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Reactors, Process Development Labs
Building One, 3rd Floor, Shanghai Campus
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GMP Manufacturing
Building One, Shanghai Campus
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GMP Pilot Labs, grams to kg/batch
Solid and solution phase synthesis
40-50 batches/year
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Scaled-up GMP Labs, crude peptide 25-50 kg/batch
(purified 5-10 kg/batch)
Solid and solution phase synthesis
25-30 batches/year
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GMP Manufacturing, Commercial Scale
Solution-Phase, Building Two
• Solution manufacturing facility
for API on metric ton scale
• Reactors from 300 L -5,000 L
• Hydrogenator 500 L
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Shanghai Campus
Distillation Systems for Solvent Purification
and Recovery
AmbioPharm, Inc
One Quality System – Two Manufacturing Plants
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Corporate SOPs to be consistent with Q7A
Site SOPs specific to the site operation
Well trained chemists for manufacturing under cGMP
Adequate QA/QC staff on both manufacturing plants
QC test and QA release of raw materials
Production Batch Record (in English)
Qualified facility, utility and equipment
QA physically controls document and drug substance
Seasoned Quality staff (>40 PAI experience of QA staff and
consultants)
AmbioPharm, Inc.
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Largest peptide manufacturing capacity; actively
expanding capacity to meet specific customer needs
> 100 years management experience in cGMP
Two manufacturing facilities to serve customers
worldwide
Dedicated facilities available for specific applications