DIRECTOR, USAMRAA, 820 CHANDLER ST, FORT DETRICK MD 21702-5014

A -- PREPARATION OF CHEMICALS AND BULK DRUG SUBSTANCES FOR THE U.S. ARMY DRUG DEVELOPMENT PROGRAM SOL DAMD17-97-R-0010 DUE 051597 POC Contract Specialist Cheryl A. Lowery (301) 619-7150 (Site Code DAMD17) A -- Requirement exists for the preparation of chemical and bulk drug substances for the U.S. Army Medical Research and Materiel Command (USAMRMC) drug development program. The objective of this project is the preparation via synthesis of quantities (gram or multikilograms) of bulk chemicals and drugs for use as potential antiparasitic (malaria or leishmaniasis) and anti-chemical agents. The major emphasis will be on the preparation of the desired compounds on a laboratory scale and will involve resynthesis and scale-up from the chemical literature or furnished procedures. Methods will be available for small scale preparation in many but not all instances. Process development for scale-up will be required. All preparations must be completely assayed as to identity and purity. The facility must have the capacity for performing all types of chemical synthesis and must be able to demonstrate organizational experience in this area. Access is required to large scale and pilot plant equipment, a minimum of one small (20-50 gallons) and one large (100 gallons or larger) glasslined reactors and necessary supporting equipment and facilities. The contractor should be registered with the FDA as a bulk drug manufacturer, be in accordance with Current Good Manufacturing Practices, and have a current Drug Master File submitted to the FDA. Requests for the solicitation must be in writing and shall reference Request for Proposals (RFP) DAMD17-97-R-0010. Requests may be faxed to Area Code 301, 619-2937. The RFP is planned for release on or about 1 April 1997. Proposals will be due 45 days after the actual issue date. See Numbered Note 1. (0072)

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