Elusys Therapeutics and Lonza today announced an agreement for the scale-up and commercial production of Anthim, a therapeutic monoclonal antibody in late-stage development for the treatment of inhaled anthrax. Under the new contract, Lonza will provide process scale-up, technology transfer, validation, and commercial manufacturing at one of its facilities in the USA. The manufacturing process for Anthim was optimized for full scale production by Lonza under a separate agreement announced in 2009. The Anthim manufacturing process uses Lonza's GS Gene Expression System.
"Elusys is pleased to extend its relationship with Lonza for the commercial production of Anthim, an anti-toxin that has been highly effective in treating anthrax infected animals," said James Porter, Vice President of Development and Manufacturing at Elusys. "Anthim has the potential to deliver significant therapeutic benefit to Americans infected with anthrax in a bioterrorism emergency and therefore, we believe that partnering with Lonza provides Elusys the manufacturing experience and large-scale capacity needed to ensure commercial quantities of Anthim long-term. As the world's leading contract manufacturer of monoclonal antibodies and recombinant proteins, Lonza has considerable experience in large-scale manufacturing and a well-established reputation with regulatory agencies for the production of licensed products."
In 2009, Elusys was awarded a contract totaling up to $143 million from the Biomedical Advanced Research and Development Authority (BARDA) within the U.S. Department of Health and Human Services to complete the final development, commercial manufacturing and licensure of Anthim. This contract represented one of the largest awarded by BARDA for advanced product development.
"Working with the team at Elusys on such a novel new antibody therapy has been very rewarding," said Dr. Stephan Kutzer, Head of Lonza Custom Manufacturing. "We are excited about continuing our successful relationship and look forward to supporting Elusys in the launch and long-term commercial supply of Anthim."
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