AMBIOPHARM, Inc.BiopharmaceuticalManufacturing and Services
2
AmbioPharm’s Mission
Ambiopharm develops andprovides contract manufacturingservices for peptides andbiopharmaceuticals at clinical andcommercial scale
AmbioPharm, Inc.API Development Services
3
Preclinical
Phase I
Phase II
Phase III
NDA
Process Development
Supportive Stability Studies
Process Validation
Process Qualification
Scale-up
AnalyticalDevelopment
AnalyticalQualification
AnalyticalValidation
FROM CLINICAL TO COMMERCIAL
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 & Utilitiesat Augusta
•GMP HVAC systems
HEPA Filters
Temperature and HumidityControls
Pressure Differential
•Utilities
Vacuum
Nitrogen supply
Chilled glycol
RO/USP water
City water
Compressed air
6
AmbioPharm’s Water Systemat Augusta
•Purified - RO/USP WaterSystem (700 gallon)
Meets USP Specification
Purification
Glassware washing
Downstream ProcessingLab
7
AmbioPharm’s Downstream Processingat Augusta
•Purification scale from gramsto 10kg per batch
Preparative HPLC systems
Preparative HPLC columns,
Lyophilizers
Analytical HPLC systems
8
AmbioPharm’s Freeze-Dryingat Augusta
•Freeze drying capacity fromgram to 20kg per batch
Manifold lyophilizers
Tray lyophilizers
Largest dedicated peptidelyophilizer in US
Isolator for packaging API
9
AmbioPharm’s Quality Controlat Augusta
•Quality Control Laboratory
HPLC
GC
LC/MS
AAA
pH Meter
Peptide Sequencer
KF
Endotoxin and
Bioburden test equipment
10
AmbioPharm’s Quality Controlat Augusta
•Cleaning and Drying Area
Automatic Glasswarewasher
Depyrogenation Oven
Steam Autoclave
11
AmbioPharm Facilitiesat Shanghai Campus
Process DevelopmentBuilding One, Shanghai Campus
•Process Development Labs•Process Development Labs
-Analytical HPLC systems-Analytical HPLC systems
-Preparative HPLC systems-Preparative HPLC systems
-Scale-up reactors-Scale-up reactors
-Fume hoods-Fume hoods
-Site and building security-Site and building security
-Staffed with process chemists-Staffed with process chemists
13
Reactors, Process Development LabsBuilding One, 3rd Floor, Shanghai Campus
•
15
GMP Manufacturing
Building One, Shanghai Campus
GMP Pilot Labs, grams to kg/batch
Solid and solution phase synthesis
40-50 batches/year
Scaled-up GMP Labs, crude peptide 25-50 kg/batch(purified 5-10 kg/batch)
Solid and solution phase synthesis
25-30 batches/year
16
GMP Manufacturing, Commercial ScaleSolution-Phase, Building Two
•Solution manufacturing facilityfor API on metric ton scale
•Reactors from 300 L -5,000 L
•Hydrogenator 500 L
Shanghai CampusDistillation Systems for Solvent Purificationand Recovery
18
AmbioPharm, Inc
One Quality System – Two Manufacturing Plants
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 andconsultants)
19
AmbioPharm, Inc.
Largest peptide manufacturing capacity; activelyexpanding capacity to meet specific customer needs
> 100 years management experience in cGMP
Two manufacturing facilities to serve customersworldwide
Dedicated facilities available for specific applications