AMBIOPHARM, Inc. Supplier of Peptide API Manufacturing and Services

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Presentation transcript:

AMBIOPHARM, Inc. Supplier of Peptide API Manufacturing and Services

Ambio Locations and History Chemspec AmbioPharm AmbioPharm USA Shanghai AmbioPharm 2005 AmbioPharm, registered in California, USA 2007 AmbioPharm, acquired UCB Bioproducts at North Augusta, SC Shanghai AmbioPharm, started at Shanghai, China 2012 Ambio formed for developing complex generic drugs 2015 Shanghai AmbioPharm built a new commercial manufacturing facility- Chemspec AmbioPharm, Shanghai, China

AmbioPharm Overview One of Leading Peptide Manufacturers in the World AmbioPharm, registered in California, USA Manufacturer of generic peptide APIs Contract manufacturing peptide APIs for pharma and biotech worldwide The company is one of leading major peptide manufacturers in the world 2 commercial generic peptide APIs and 18 generic peptide APIs in the development pipelines >100 NCE peptide CMO projects.

Generic Peptide APIs Generic Peptide API Manufacturer Generic Peptide Portfolio API’s Available Today: Bivalirudin (DMF, FDA approved) Eptifibatide (DMF, FDA approved) Glucagon (DMF) Leuprolide (DMF) Octreotide (DMF) Glatiramer (DMF) Teriparatide Nesiritide Exenatide Carbetocin Liraglutide (DMF) Corticotropin Teduglutide Lanreotide In Development: Pramlintide Ganirelix Cosyntropin Triptorelin Goserelin Linaclotide Vasopressin

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    

Seasoned Management Team Name Role Experience Chris Bai, PhD President & CEO 20 years in pharmaceutical manufacturing Jim Hampton, BS Exec VP of BD and Sales 20 years in pharmaceutical business development Ruoping Zhang, BS VP Manufacturing 18 years in peptide API manufacturing Stephen Kiel, MBA, CPA CFO 35 years in financial management Robert Geiger, PhD VP Quality 15 years in pharmaceutical quality management Simrat Singh, PhD Sr. Director Operations 10 years in pharmaceutical product development Isabel Tan Sr. Director of Quality 10 years in pharmaceutical quality management Guoging Zhang Sr. Director of Mfg & Process 10 years in peptide API manufacturing Sherry Li Sr. Director of Analytical & QC 10 years in pharmaceutical quality control

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 Shanghai site: 2 “483” observations October 2014, FDA PAI of US site: 1 ‘483’ observation January 2016, FDA audit of Shanghai site: no “483” observations

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

API Manufacturing Facility at North Augusta Building No. 200 and 300 60cm HPLC Column 400L Lyophilizer Warehouse

Current API Purification Capacity 400 kg/year within Building No. 200

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

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

AmbioPharm Expanding its Headquarter at North Augusta, South Carolina, USA

API Synthesis Facility at Shanghai Building No.1 20 kg/batch & 300 kg/year Crude Peptide Process Development, cGMP Pilot, and Large-Scale API Manufacturing Facilities

API Synthesis and Purification Facility at Shanghai Building No API Synthesis and Purification Facility at Shanghai Building No. 13, Commercial Manufacturing 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

Synthesis Manufacturing Capacity 200 kg crude/batch & 2000 kg crude/year 30 solid phase reactors 1L, 5L, 10L, 30L, 50L, 80L, 200L (up to 20 kg crude/batch) 20 solution phase reactors 10L, 20L, 30L, 50L, 80L, 200L (up to 40kg crude/batch) 1000L Solid Phase Reactor (up to 100 kg crude/batch) 5000L Solution Phase Reactor (up to 200 kg crude/batch) 18 18

AmbioPharm Designing and Building a New Chinese Facility at Shanghai to be completed by 2018

Increase Peptide API Manufacturing Capacity to 400kg/year by 2016

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

Process Development Center at North Augusta and Shanghai The Process development group works to achieve the following goals: Efficacy and selectivity (reach the requirements in terms of quality) Scalability (transferable into large to very large scale) Productivity (good yield and recovery of the target) Reproducibility (repeated campaigns must produce the API with the same profile) Robustness Safe with regard to people and environment

Analytical Development Group at North Augusta and Shanghai In parallel with the process development, analytical development provides tools that are able to: Monitor the process for side reactions Monitor the process to reach required purity Monitor the process to limit the residual impurities Control the final API and ensure the required quality attributes Provides “cushion” of impurities to allow formulators more breathing room

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 would reduce 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 generic APIs