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SwRI receives $1.7 million contract for pharmaceutical process development
San Antonio -- November 16, 2005 -- In the face of increasing threats of terrorist attacks using chemical weapons, the U.S. Army Space and Missile Defense Command has awarded Southwest Research Institute® (SwRI®) a four-year, $1.79 million contract to provide clinical supplies of chemical weapon antidotes to the Medical Identification and Treatment Systems Joint Product Management Office. Chemical weapons have been used in military conflicts since World War I, but the threat of chemical terrorism became a reality in the 1990s when the chemical agent sarin was released into the Japanese subway system.
Chemical exposure can also occur from industrial accidents or military stockpiles. To address these very real threats, SwRI will supply acetylcholinesterase reactivators, which reverse nervous or respiratory systems symptoms.
"We plan to complete synthesis development, scale-up and manufacturing in the first year," said Dr. Joe McDonough, project manager and Manager of the Synthesis and Drug Delivery Section in SwRI's Chemistry and Chemical Engineering Division. "Stability studies will follow during the subsequent three years. We anticipate having the pharmaceutical product available for clinical studies in 2006."
SwRI is managing the project and will perform intermediate process scale-up to assess the overall production process, using its extensive experience in pharmaceutical synthesis, process development, scale-up, process validation and drug delivery methods.
SwRI is teaming with SRI International, Menlo Park, Calif., and Cambrex Charles City Inc. (CCC) for the project. SRI will provide the synthesis route and early-stage analytical development. CCC will manufacture 10 kilograms of the product's active pharmaceutical ingredient in compliance with cGMP (current good manufacturing practices). All three organizations meet cGMP (current) practice requirements.
"We have conducted many projects requiring synthesis development, scale-up and manufacturing, but this will be the largest we have undertaken. We look forward to demonstrating our strengths in this area," McDonough said.
For more than 50 years, SwRI has been a leader in the development of products for the pharmaceutical, agricultural, consumer goods, and food industries and has pioneered the development of new microencapsulation techniques.
SwRI's Chemistry and Chemical Engineering Division is ISO 9001:2000 certified, meeting international quality standards for product development, from initial design through production and servicing. For more information about SwRI's Chemistry and Chemical Engineering Division, please visit chemistry.swri.org. For more information about microencapsulation at SwRI, please visit microencapsulation.swri.org.
About Cambrex Charles City Inc.
About SRI International
For more information, contact Tracey M.S. Whelan, Communications Department, (210) 522-2256, Southwest Research Institute, PO Drawer 28510, San Antonio, TX 78228-0510.