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A MBIO P HARM, Inc. Supplier of Peptide API Manufacturing and Services. Ambio Locations and History. Chemspec AmbioPharm. AmbioPharm USA. AmbioPharm, registered in California, USA. 2005. AmbioPharm , acquired UCB Bioproducts at North Augusta, SC
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AMBIOPHARM, Inc.Supplier of Peptide API Manufacturing and Services
Ambio Locations and History ChemspecAmbioPharm AmbioPharm USA • AmbioPharm, registered in California, USA 2005 • AmbioPharm, acquired UCB Bioproducts at North Augusta, SC • Shanghai AmbioPharm, started at Shanghai, China 2007 Shanghai AmbioPharm 2012 • Ambio formed for developing complex generic drugs 2015 • Shanghai AmbioPharm built a new commercial manufacturing facility- ChemspecAmbioPharm, Shanghai, China
AmbioPharm OverviewOne 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 ManufacturerGeneric 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
Chris Bai Chief Executive Officer Jim Hampton Exec VP of Bus Dev Robert Geiger VP of Quality HR & Administration Ruoping Zhang VP of Manufacturing Production Director of Sales Proc Dev Quality Control QA and Regulatory Analytical Dev Downstream US, EU, Canada, Asia Sales reps Facilities Synthesis Chemist Chemist QA Manager Microbiologist Chemist Technician Chemist
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 ShanghaiBuilding No. 13, Commercial Manufacturing Dedicated manufacturing line offers further cost savings at larger scale.
1st to 3rd Floor of Building No. 131000L Solid Phase Reactors5000L Solution Phase Reactors
5th Floor of Building No. 134 Purification Suites20cm, 30cm, 45cm HPLC Purification Columns
Synthesis Manufacturing Capacity200 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
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 producethe 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
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