Sunday, September 19, 2021
HomeBiotechCEM Corporation & AmbioPharm Form U.S. Partnership for GMP Peptide Production

CEM Corporation & AmbioPharm Form U.S. Partnership for GMP Peptide Production

MATTHEWS, N.C. & NORTH AUGUSTA, S.C.– CEM Corporation and AmbioPharm, Inc. are excited to announce the formation of a partnership for production of GMP peptides for the global market. The partnership will involve an exclusive1 use of CEM’s large-scale microwave peptide synthesis technology for the production of GMP peptides up to multi-kilogram quantities using proprietary scalable reactors. The key benefits of this new relationship are extremely rapid production times, the ability to efficiently produce more difficult peptide sequences, and the ability to incorporate green chemistry protocols. This partnership will enable rapid and efficient production of peptide new chemical entities (NCE’s) using the latest technologies available. With this agreement, AmbioPharm has commenced peptide synthesis operations in its North Augusta facility to better serve customers with expedited microwave synthesis capabilities.

CEM’s technology for peptide production utilizes automated large-scale microwave solid-phase peptide synthesis (SPPS) systems that have been established for improving peptide purity and minimizing excess reagents needed. Additionally, CEM has developed proprietary coupling methodologies optimized for elevated temperature reactions2, a unique way to combine the coupling and deprotection reactions into a single step3, and established the use of greener solvents that are more accessible using elevated temperatures4. These unique technology benefits will be licensed to AmbioPharm for GMP production.

AmbioPharm is a recognized leader in cGMP peptide production. The company employs more than 675 employees and recently completed a major expansion at its headquarters in South Carolina, US, adding nearly 56,000 sq. ft of additional peptide manufacturing capacity. The production facility has the purification capability of up to 30 kg/batch and a lyophilization capacity of up to 1,000L. The CEM Liberty Pro synthesizer offers differing reactor sizes (3, 8 and 15 liter) allowing synthesis of batches from 5 g to 500 g of final peptide.

“Peptide based drugs have enormous potential for the future and we are excited to contribute to improving their production process. AmbioPharm is an ideal partner, and we believe this relationship will provide enhanced capabilities for the production of peptide therapeutics.” – Michael J. Collins, Ph.D., President & CEO of CEM Corporation.

“With the addition of CEM’s microwave technology into our GMP peptide manufacturing options, we can offer even better service in terms of expedited delivery for our partners’ products as well as unique capabilities for making longer and more complex peptides accessible with microwave methods.” – Chris Bai, Ph.D., CEO of AmbioPharm Inc.

Both companies will be exhibiting at the upcoming TIDES USA conference in September 2021.

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