AMBIOPHARM, Inc. Peptide API Manufacturing and Services

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Presentation transcript:

AMBIOPHARM, Inc. Peptide API Manufacturing and Services

AmbioPharm History AmbioPharm, registered in California, USA in 2005 AmbioPharm, acquired UCB Bioproducts at North Augusta, SC in 2007 Shanghai AmbioPharm, started at Shanghai, China in 2007 Chemspec and AmbioPharm Joint Venture Facility, Shanghai, China in 2014 AmbioPharm USA Shanghai AmbioPharm Chemspec AmbioPharm

Compliance & Inspection History November 2008, FDA audit of USA site: no 483 observations August 2011, FDA audit of USA site: no 483 observations October 2011, sFDA audit of Shanghai site: no observations March 2013, FDA PAI of USA site: 4 “483” observations August 2013, FDA PAI of Hainan site: 3 “483” observations August 2013, FDA PAI of Shanghai site: 2 “483” observations August 2014, FDA approved Shanghai AmbioPharm (EIR Letter) October 2014, FDA PAI of US site: 1 ‘483’ observation November 2014, FDA approved AmbioPharm US site (FDA Letter)

Seasoned Management Team Chris Bai, Ph.D. President & CEO  18 years in pharmaceutical manufacturing experience. Former president and CEO of American Peptide Company Jim Hampton, BS, MS, Exec VP of BD and Sales  18 years in pharmaceutical business development Ruoping Zhang, BS, VP of Manufacturing 14 years in peptide API manufacturing experience. Robert Geiger, Ph.D. MBA. VP of Quality 14 years in pharmaceutical QA/QC, business development Simrat Singh, Ph.D., Director of Analytical & QC 8 years in Pharmaceutical product development Stephen Kiel, MBA, CPA, Chief Financial Officer 35 years experience in financial management

Chief Executive Officer   Chris Bai Chief Executive Officer     Jim Hampton Exec VP of Bus Dev Robert Geiger VP of Quality HR & Administration   Ruoping Zhang VP of Manufacturing       Proc Dev Production   Director of Sales   Quality Control     QA and Regulatory Analytical Dev   Downstream       US, EU, Canada, Asia Sales reps Facilities Synthesis   Chemist       QA Manager Microbiologist Chemist Chemist Technician   Chemist    

AmbioPharm Manufacturing Sites Non-Sterile API Peptide Manufacturing AmbioPharm, Inc.- World HQ in North Augusta, SC USA Shanghai , China NCEs Synthesis Analytical Dev R&D North Augusta, SC NCEs downstream mfg QC testing QA release Hainan, China Generics Synthesis Generics Downstream Generics Final product

AmbioPharm, N. Augusta, SC USA 32 acres acquired from UCB Pharma in 2006 Existing cGMP/Process Development facility on 2 acres

Expansion of North Augusta Manufacturing Facility 60cm HPLC Column 400L Lyophilizer Warehouse

Purification Capacity by 2015 28 kg/batch and 300 kg/year

Non-Sterile Peptide API Manufacturing Purification Scale from 1 gram up to 30 kg/batch Final Peptide Preparative HPLC columns: ID: 5, 8, 15, 20 and 30cm (up to 7kg/batch) ID: 45cm (up to 15 kg/batch) ID: 60cm (up to 28 kg/batch)

Non-Sterile Peptide API Manufacturing Freeze Drying Capacity Four (4) Manifold lyophilizers (up to 1kg/batch) 100L tray lyophilizer to be installed by Q4 2014 (up to 7 kg/batch) 200L tray lyophilizer (up to 15 kg/batch) 400L tray lyophilizer (up to 30 kg/batch)

Phase II Expansion- Q3 2015 Tank Farm for Additional Solvent Capacity Annex to House 60cm Column Water System & Future Expansion Area

AmbioPharm Facilities - Shanghai Campus

Process Development, cGMP Pilot, and Large-Scale API Manufacturing Facilities

Manufacturing Expansion of 30,000 ft2 Completed at Shanghai Facility Dedicated manufacturing line offers further cost savings at larger scale.

1st to 3rd Floor of Building No 1st to 3rd Floor of Building No. 13 1000L Solid Phase Reactors 5000L Solution Phase Reactors

5th Floor of Building No. 13 4 Purification Suites 20cm, 30cm, 45cm HPLC Purification Columns

2015 Synthesis Manufacturing Capacity 200 kg crude/batch & 2,000 kg crude/year 30 solid phase reactors 1L, 5L, 10L, 30L, 50L, 80L, 200L (up to 20kg crude/batch) 20 solution phase reactors 10L, 20L, 30L, 50L, 80L, 200L (up to 40kg crude/batch) New 1,000L Solid Phase Reactor (up to 100kg crude/batch New 5,000L Solution Phase Reactor (up to 200kg crude/batch) 18

Final Product Release Quality Control Laboratory HPLC (12) GC (2) LC/MS (2) IC SEC Amino acid analysis UPLC KF Endotoxin and Bioburden

AmbioPharm’s Advantage – Low Cost of Manufacturing Close to all the major raw material manufacturing companies (amino acid derivatives and solvents) Low cost to manufacture under fully controlled cGMP quality system and experienced management team Low cost on solvents DMF, a major cost for peptide synthesis on large scale US Competitor’s cost: $3,500/ton AmbioPharm’s cost: $1,450/ton The solvent recovery system reduces the manufacturing cost further on larger scales

Manufacturing Cost Comparison

AmbioPharm, Inc. Largest peptide manufacturing capacity; actively expanding capacity to meet specific customer needs > 100 years management experience in cGMP The highest technical capabilities in the peptide industry Three manufacturing facilities to serve customers worldwide Setting a new standard for the quality of APIs