Kyowa Hakko USA Addresses FDA TSE/BSE Committee Meeting on Amino Acid Production Method Safety

January 2, 2002

New York, N.Y. - A recent meeting of the U.S. Food and Drug Administration's Transmissible Spongiform Encephalopathies (TSE) Advisory Committee brought together several industry leaders to discuss amino acid production and the associated theoretical risk of contamination from their use in the production of biological products.

One of the world's largest producers of amino acids, Kyowa Hakko submitted detailed information on its fermentation techniques for the production of amino acids. The process, pioneered by Kyowa Hakko nearly half a century ago, utilizes no animal-derived materials.

The Kyowa fermentation production method is particularly noteworthy since FDA concerns focus on the materials from which amino acids are derived and the processes used to manufacture and purify them. At issue is the potential contamination with the bovine spongiform encephalopathy (BSE) agent of bovine-derived source material used in the manufacture of US-licensed bio-pharmaceutical products, and possible exposure resulting from the use of amino acids of bovine origin if these were obtained from animals infected with the BSE agent.