Director, USAMRAA, 820 Chandler St, Fort Detrick, MD 21702-5014

99 -- ESTABLISH A SECOND SOURCE FOR THE MANUFACTURE OF ANTHRAX VACCINE ADSORBED DUE 073100 POC Lynn Selfridge, Contracting Officer, (301) 619-2707; Ms. Winifrede Fanelli, JPO-BD, (703) 681-9648 E-MAIL: Lynn.Selfridge@det.amedd.army.mil, fanelliw@jpobd.osd.mil. The Joint Program Office for Biological Defense and the Department of the Army, as the executive agent, are seeking to identify sources to establish a second source for the manufacture of anthrax vaccine adsorbed (AVA). Potential manufacturers must have a cGMP compliant biosafety level-3 facility available and must agree to share the FDA license for the product with the current license holder. Given the Department of Defense's critical need for this product start-up time will be minimal. The proposal process will be abbreviated with award before 1 October 2000 anticipated. Interested parties need to reply in writing to the address included in this synopsis above. An acceptable response must include past performance information indicating experience manufacturing vaccines. Demonstration of knowledge of good manufacturing practices and knowldege of the Food and Drug Administration (FDA) regulatory requirements by submitting a copy of recent internal and external quality assurance audits and FDA inspection reports is also required. Interested parties must also describe in their response experience with bio-safety level-3 material and the availability of a compliant facility. Also to be included is a brief description of the management team that is in-place, or could be put in-place, that has successfully worked together as a team in the achievement of a specific goal, to facilitate commencing the effort immediately after award of contract. This synopsis is not a request for proposal, this is a notice to determine the level of interest and capability available to meet the requirement of expeditiously developing a second manufacturer of AVA. See Note 23. Posted 06/30/00 (W-SN470542). (0182)

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