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

A -- A -- PREPARATION OF CHEMICALS AND BULK DRUG SUBSTANCES FOR THE U.S. ARMY DRUG DEVELOPMENT PROGRAM SOL DAMD17-98-R-0023 DUE 100198 POC Contract Specialist Kathy Hackley (301) 619-7432 (Site Code DAMD17) A-PREPARATION OF CHEMICALS AND BULK DRUG SUBSTNACES FOR THE U.S. ARMY DRUG DEVELOPMENT PROGRAM -- Solicitation No. DAMD17-98-R-0023 Due 100198. POC Kathy Hackley, Contract Specialist (301)619-7432 (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 object of this program is to develop prophylactic and therapeutic drugs for use by its soldiers. The USAMRMC is responsible for the development of drugs against parasitic and infectious diseases, and chemical and biological agents. Drug development is a continuous process with many studies proceeding concurrently. Fundamental to the drug development process is the ability to provide various quantities of the potential drugs in a high degree of purity to the numerous in-house and extramural investigators. This project provides the means for obtaining the needed compounds and bulk drugs in the quality and quantity required. Assignments of materials preparation will originate with the Department of Medicinal Chemistry, Division of Experimental Therapeutics, Walter Reed Army Institute of Research (WRAIR), and will involve a wide variety of chemical structures. The major emphasis will be on the preparation via synthesis 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. The design of new procedures and methods and 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. The contractor shall have an operating and functional large scale or pilot plant facility with minimum of one small (20-50 gallons) and one large (100 gallons or larger) glass-lined reactors with necessary supporting equipment. The contractor shall 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. Request for the solicitation must be in writing and shall reference Request for Proposal (RFP DAMD17-98-R- 0023. Requests may be faxed to (301) 619-4084. The RFP is planned for release on or about 15 August 1998. Proposals will be due 45 days after the actual issue date. See numbered Note 1. Posted 08/13/98 (I-SN236723). (0225)

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