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DOR BioPharma and Cambrex Enter into a Development and Manufacturing Process Agreement for RiVax(TM)

20 Jan 2005 - DOR BioPharma, Inc. and a subsidiary of Cambrex Corporation have entered into an agreement with respect to process development for potential large scale production of DOR's proprietary ricin vaccine, RiVax(TM). Under the agreement, Cambrex will provide process development and cGMP (current Good Manufacturing Processes) production services for RiVax(TM).
 
Ricin toxin is a potential bioterror threat due to its highly lethal toxicity in small doses, ease of manufacture, and ability to be aerosolized. The need for protective countermeasures against ricin has been emphasized by its recent and continued use as a biological weapon.
 
"We believe RiVax(TM) could be an integral part of the U.S. Government's biodefense arsenal," stated Gregory J. Davenport, Ph.D., President of DOR's Biodefense Division. "Cambrex has significant cGMP capacity and a proven track record of manufacturing other developmental vaccines. We are pleased to be working with Cambrex as we endeavor to meet all the requirements for potential procurement by the U.S. Government."
 
DOR will work with Cambrex pursuant to DOR's recently awarded $5.2 million National Institutes of Health (NIH) ricin vaccine development grant. The specific milestones for the RiVax(TM) development program funded under the grant to be undertaken by Cambrex include development of a robust process for production and purification of the vaccine. Under the current agreement, Cambrex will be developing the manufacturing process to enable large scale production to produce quantities sufficient for additional clinical testing, fulfillment of all FDA requirements for licensure and, approved, commercial production.