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A MBIO P HARM, Inc. Biopharmaceutical Manufacturing and Services

A MBIO P HARM, Inc. Biopharmaceutical Manufacturing and Services. AmbioPharm’s Mission. Ambiopharm develops and provides contract manufacturing services for peptides and biopharmaceuticals at clinical and commercial scale. AmbioPharm, Inc. API Development Services.

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A MBIO P HARM, Inc. Biopharmaceutical Manufacturing and Services

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  1. AMBIOPHARM, Inc.Biopharmaceutical Manufacturing and Services

  2. AmbioPharm’s Mission Ambiopharm develops and provides contract manufacturing services for peptides and biopharmaceuticals at clinical and commercial scale

  3. 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 Process Qualification ProcessValidation

  4. AmbioPharm N. Augusta, SC USA • 32 acre site acquired from UCB Bioproducts in 2006 • 20,000 sq. ft. cGMP and process development areas

  5. AmbioPharm, USA Two Acres in Current Footprint

  6. AmbioPharm’sHVAC Systems & Utilitiesat Augusta • GMP HVAC systems • HEPA Filters • Temperature and Humidity Controls • Pressure Differential • Utilities • Vacuum • Nitrogen supply • Chilled glycol • RO/USP water • City water • Compressed air

  7. AmbioPharm’s Water System at Augusta • Purified - RO/USP Water System (700 gallon) • Meets USP Specification • Purification • Glassware washing • Downstream Processing Lab

  8. AmbioPharm’s Downstream Processing at Augusta • Purification scale from grams to 10kg per batch • Preparative HPLC systems • Preparative HPLC columns, • Lyophilizers • Analytical HPLC systems

  9. AmbioPharm’s Freeze-Dryingat Augusta • Freeze drying capacity from gram to 20kg per batch • Manifold lyophilizers • Tray lyophilizers • Largest dedicated peptide lyophilizer in US • Isolator for packaging API

  10. AmbioPharm’s Quality Controlat Augusta • Quality Control Laboratory • HPLC • GC • LC/MS • AAA • pH Meter • Peptide Sequencer • KF • Endotoxin and Bioburden test equipment

  11. AmbioPharm’s Quality Controlat Augusta • Cleaning and Drying Area • Automatic Glassware washer • Depyrogenation Oven • Steam Autoclave

  12. AmbioPharm Facilities at Shanghai Campus

  13. Process DevelopmentBuilding 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

  14. 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 Scale Solution-Phase, Building Two • Solution manufacturing facility for API on metric ton scale • Reactors from 300 L -5,000 L • Hydrogenator 500 L 16

  17. Shanghai CampusDistillation Systems for Solvent Purification and 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 and consultants)

  19. AmbioPharm, Inc. • 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

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