AmbioPharm, a provider of peptide API CDMO services, made state-of-the-art upgrades to its AmbioPharm South Carolina headquarters, including increasing synthesis capacity.

In a statement, the company said that in order to accommodate and support growth in late phase and commercial production, they have made recent installations including:

• 1M high-performance liquid chromatography column (HPLC)
• 1,000L lyophilizer
• Tangential flow filtration system with centrifuge
• Large walk in 2-8 degree Celsius stability chamber
• -20 degree Celsius walk in freezer

They have also added the following equipment to increase U.S. 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

The microwave peptide synthesizers enable this location to perform U.S. crude peptide production for both nonGMP and GMP requirements, with plans for additional synthesis capacity in the future.

In addition, the company has made technology investments in its quality qrganization including the implementation of master control as a part of the quality management system (QMS) as we strive to build quality into every step of our process.

The upgrades allow AmbioPharm to continue to support its customers from early phase toxicology batches through large scale commercial manufacturing, with annual production capacity up to a metric ton.