AmbioPharm, a Global Peptide CDMO

• Global Peptide CDMO with China and US Manufacturing Facilities

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:

• 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
• Solvent recycling

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:

• 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

We have also added the following equipment to increase US production using greener chemistry to support manufacturing:

• 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

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

[email protected]