Enterotoxigenic Escherichia Coli Manufactured Product
Closed Pre-Solicitation Posted
- Solicitation number
- HT9425-24-SSN-TJK1
- Agency
-
Defense Health Agency
Department of Defense
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541714 Research and Development in Biotechnology (except Nanobiotechnology)
- PSC
- Q517 Pharmacy Services
- Place of performance
- Frederick, North Dakota, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Defense Health Agency is seeking a cGMP-manufactured product suitable for use in pivotal clinical studies to demonstrate efficacy against Enterotoxigenic Escherichia coli (ETEC) in adults, with the goal of FDA licensure. The objective is to support the development of a multivalent ETEC vaccine to prevent bacterial diarrhea in Warfighters. Potential offerors must include the preparation of a Controlled Human Infection Model (CHIM) Phase 3 Clinical study and conversion of FDA required documentation into the required format. Offerors will use a European Contract Manufacturing Organization (CMO) to meet FDA quality requirements.
This is a pre-solicitation notice, with no set-aside designation. The notice does not mention any potential incumbents or current contractors. The announcement does not provide any details on award value or budget ranges, nor does it specify quantities of goods or timelines for services.
Notice text
The primary objective of this sources sought notice is delivery of a cGMP manufactured product of quantity and quality that it is suitable and appropriate for use in pivotal clinical studies to demonstrate efficacy against Enterotoxigenic Escherichia coli (ETEC) in adults with the goal of FDA licensure. The objective activities will support a multivalent ETEC vaccine with the long-term goal of preventing bacterial diarrhea in Warfighters. Potential offerors must include the preparation of a Controlled Human Infection Model (CHIM) Phase 3 Clinical study and conversion of FDA required documentation into the FDA required format. Potential offerors will use a European Contract Manufacturing Organization (CMO) to meet FDA quality requirements.
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