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A MBIO P HARM, Inc. Biopharmaceutical Manufacturing and Services.

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Presentation on theme: "A MBIO P HARM, Inc. Biopharmaceutical Manufacturing and Services."— Presentation transcript:

1 A MBIO P HARM, Inc. Biopharmaceutical Manufacturing and Services

2 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 3 Preclinical Phase IPhase IIPhase IIINDA Process Development Supportive Stability Studies Process ValidationProcess QualificationScale-up Analytical Development Analytical Qualification Analytical Validation FROM CLINICAL TO COMMERCIAL

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

5 AmbioPharm, USA Two Acres in Current Footprint

6 AmbioPharm’s HVAC Systems & Utilities at 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 6

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

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

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

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

11 AmbioPharm’s Quality Control at Augusta Cleaning and Drying Area  Automatic Glassware washer  Depyrogenation Oven  Steam Autoclave 11

12 AmbioPharm Facilities at Shanghai Campus

13 Process Development Building One, Shanghai Campus Process Development LabsProcess Development Labs -Analytical HPLC systems -Preparative HPLC systems -Scale-up reactors -Fume hoods -Site and building security -Staffed with process chemists 13

14 Reactors, Process Development Labs Building One, 3 rd Floor, Shanghai Campus

15 15 GMP Manufacturing Building One, Shanghai Campus GMP Pilot Labs, grams to kg/batch Solid and solution phase synthesis batches/year Scaled-up GMP Labs, crude peptide kg/batch (purified 5-10 kg/batch) Solid and solution phase synthesis batches/year

16 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

17 Shanghai Campus Distillation Systems for Solvent Purification and Recovery

18 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 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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