SHANGHAI–(BUSINESS WIRE)–#cGMP—AmbioPharm, a worldwide leader in peptide API CDMO services, 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.
AmbioPharm Shanghai Campus
The latest addition to the AmbioPharm Shanghai campus brings a total of approximately 380,550 ft2 (35,354 m2) 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:
AmbioPharm US Headquarters and Campus
Recently inspected by the FDA in February of 2023, the AmbioPharm North Augusta campus, located in South Carolina, USA, was recently expanded in 2020 and totals 82,566 ft2 (7,670 m2) of administrative and manufacturing space. Working in close collaboration with our Shanghai campus, we offer end-to-end peptide manufacturing for clinical and commercial applications. To accommodate and support growth in late phase and commercial production, we have made recent installations to this campus including:
We have also added the following equipment 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.
We made technology investments in our Quality Organization including the implementation of Master Control as a part of the Quality Management System (QMS), in both the USA and China, as we build quality into every step of our process.
These upgrades allow AmbioPharm to support our customers from early phase Toxicology batches through large scale commercial manufacturing, with annual production capacity up to a metric ton. Using our expertise, we can tackle both simple and complex peptide projects with a proven history of success at research, clinical, and commercial scales.
Further information is available at: https://www.ambiopharm.com
Contacts
AmbioPharm
Mark DaFonseca, EVP, Sales & Global Business Development
mark.dafonseca@ambiopharm.com
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