AmbioPharm continues growth to meet capacity demands for late phase and commercial peptide production. A reliable peptide CDMO with manufacturing facilities both in China and the USA, AmbioPharm is ready to meet the needs of a global market.
 
The latest addition to the AmbioPharm Shanghai campus brings a total of approximately 380,550 ft² of manufacturing and administrative space. The ongoing expansion includes reactors up to 5,000 liters and additional purification suites, including a new 60cm HPLC column. A hydrogenation facility for Liquid Phase Peptide Synthesis (LPPS) was also recently completed and fully qualified.
 
An additional building is currently underway featuring state-of-the-art 3,000L SPPS and 3,000L LPPS systems and is expected to come online as early as Q4, 2023.

Expansion highlights include Process optimization suites, Purification suite expansion, including 60cm HPLC column, precipitation suite, cGMP pilot synthesis suite, hydrogenation facility for LPPS, 6 manufacturing lines with 71 reactors with plans to add 7 additional lines for large scale and commercial production and Solvent recycling

Recently inspected by the FDA, the AmbioPharm North Augusta campus, located in South Carolina, USA, was expanded in 2020 and totals 82,566 ft² of administrative and manufacturing space. Working in close collaboration with our Shanghai campus, it offers end-to-end peptide manufacturing for clinical and commercial applications.

To accommodate and support growth in late phase and commercial production, the firm has made recent installations to this campus including 1M high-performance liquid chromatography column (HPLC), 1,000L lyophilizer, tangential flow filtration system with centrifuge, large walk in 2-8 ?C stability chamber, -20 ?C walk in freezer.

CEM Liberty Blue microwave peptide synthesizer (for small scale, non-GMP solid phase peptide synthesis (SPPS)), CEM Liberty Pro microwave peptide synthesizer (for GMP solid phase peptide synthesis (SPPS) with scales up to 15L reactor capacity) YMC Twin-column chromatography have been added to increase US production using greener chemistry to support manufacturing.

Microwave peptide synthesizers enable this location to perform US crude peptide production for both nonGMP and GMP requirements, with future plans for additional synthesis capacity.

Technology investments have been made in Quality Organization including the implementation of Master Control as a part of the Quality Management System (QMS), in both the USA and China. 

These upgrades allow AmbioPharm to support its customers from early phase Toxicology batches through large scale commercial manufacturing, with annual production capacity up to a metric tonne.