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

MATTHEWS, N.C. & NORTH AUGUSTA, S.C.–(BUSINESS WIRE)–#cGMP–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.

About CEM

CEM Corporation, a private company based in Matthews, North Carolina, is a leading provider of laboratory instrumentation. The company has subsidiaries in the United Kingdom, Germany, Italy, France, Japan, and Singapore, as well as a global network of distributors. CEM designs and manufactures systems for life sciences, analytical laboratories and processing plants worldwide. The company’s products are used in many industries including pharmaceutical, biotech, chemical and food processing, as well as academic research. Further information is available at: https://www.cem.com.

About AmbioPharm, Inc.

AmbioPharm, a part of the Ambio Pharmaceuticals Group, is a leading and innovation-driven company specializing in the development and manufacture of peptides and peptide-related products. With a comprehensive range of services, AmbioPharm produces custom products for research, clinical development, and commercial application to pharmaceutical and biotechnology companies worldwide. Headquartered in the United States of America and with locations in Europe, the USA, and Asia, AmbioPharm operates internationally with over 14 years of experience and expertise. Further information is available at: https://www.ambiopharm.com.

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¹ With limited provisional exceptions

² US 10,858,390; US 9,969,769; EP17188963.7; JP2016138090

³ US20170226152; WO2017070512; WO2018044356A1

⁴ US 11,014,959; WO2019241586A1

Contacts

CEM Corporation

Jonathan M. Collins

VP Business Development

jon.collins@cem.com

Michael J. Karney

Life Science Product Manager

michael.karney@cem.com

AmbioPharm, Inc.

Michael Pennington, Ph.D.

Chief Scientific Officer

mike.pennington@ambiopharm.com