U.S. ARMY MED. RESEARCH ACQUISITION ACT, MCMR-AAA, FORT DETRICK BLDG. 820, FREDERICK MD 21702-5014

A -- SOURCES SOUGHT SOL DAMD17-CBD5-0012 DUE 083095 POC Craig D. Lebo, Contracting Officer The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) is developing a new vaccine against Venezuelan equine encephalitis (VEE) virus. USAMRIID is interested in obtaining the names of firms which have the capabilities to produce the new vaccine under Good Manufacturing Practices (GMP), and firms which can conduct the associated Good Laboratory Practice (GLP) safety and toxicity studies. These two types of research and development work may be funded for which interested parties may propose to do either or both. These are: (1) production of a new VEE vaccine from a full-length, infectious cDNA clone of an attenuated VEE virus (vaccine should have a minimum shelf life of 24 months); and (2) performance of GLP safety and toxicity studies including monkey neurovirulence studies with the new GMP product. All work must be conducted within Biosafety level 3+ biocontainment with HEPA-filtered exhaust. Workers will need to be vaccinated against VEE with current IND vaccines, TC-83/C-84 which require HIV and pregnancy testing before administration. Approximately 10,000 doses of vaccine will be required with a potential future requirement of several million doses. All work must be in accordance with all applicable Federal regulatory requirements (per GMP and GLP in CFR 21). Part of the production and testing efforts will be the rquirement to provide sufficient data to support IND submission. Said firm must have available to it the regulatory affairs and manufacturing capabilities as part of its organization or under its influence. Information on qualifications, experience, facilities, and personnel should be forwarded within 15 days of this notice. (0191)

Loren Data Corp. http://www.ld.com (SYN# 0008 19950711\A-0008.SOL)