Procurement of GMP Manufactured QS-21
Closed Solicitation Posted
- Solicitation number
- HT942524Q0047
- Agency
-
Defense Health Agency
Department of Defense
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 325411 Medicinal and Botanical Manufacturing
- PSC
- 6505 Drugs And Biologicals
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Defense's Defense Health Agency is seeking to procure the manufacturing of a minimum of 20,000 doses of Army Liposome Formulation containing QS-21 (ALFQ) under Current Good Manufacturing Practices (cGMP). This new requirement is in support of the Walter Reed Army Institute of Research's Phase 1/2A and 2B clinical trials. The key objectives are to provide the necessary GMP-manufactured ALFQ to support the clinical trials. The evaluation will likely focus on the offeror's ability to meet the cGMP manufacturing requirements within the specified timeline. Proposals are due by June 18, 2024.
This procurement is not set aside for any particular business size or socioeconomic category. There is no information provided about potential incumbents or the expected award value. The place of performance is not specified, but the manufacturing must be conducted under cGMP conditions to support the clinical trials.
Notice text
3 versions
Update #3 · Latest ·
The purpose of the Amendment 0002 of Solicitation HT9425-24-Q-0047 is due to the following:1. To provide answers to questions received from industry.2. To provide updates to MECS3. To extend proposal due date to 18 June 20244. To provide Attachments as part of the answers from questions receivedThe copy of the copies of amended solicitation HT9425-24-Q-0047-0002 attached is posted twice and they are the same documents.No more questions will be accepted at this time.
Update #2 ·
The purpose of the amendment to the solicitation is to extend proposal due date to 14 June 2024 while responses are being prepared for questions received.
Update #1 ·
This is a new requirement for Research and Development requirement for the manufacturing of (minimum of 20,000 dose/lot) of Army Liposome Formulation containing QS-21 (ALFQ) under Current Good Manufacturing Practices (cGMP), in support of Walter Reed Army Institute of Research (WRAIR), Phase 1/2A and 2B Clinical Trials.
Notice history
| Notice | Type | Posted |
|---|---|---|
| This notice | Solicitation | |
| Procurement of Good Manufacturing Practice (GMP) QS-21 | Pre-Solicitation |
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