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Procurement of GMP Manufactured QS-21   2

ID: HT942524Q0047 • Type: Solicitation • Match:  100%
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Description

Posted: June 11, 2024, 2:47 p.m. EDT
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.
Posted: June 4, 2024, 10:20 a.m. EDT
Posted: May 8, 2024, 7:31 a.m. EDT
Background
This is a new requirement for Research and Development for the manufacturing of a 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.

Work Details
Procurement of GMP Manufactured QS-21. Product is to be provided in two containers, half in each. QS-21 shall be delivered in two containers, half in each to facilitate the manufacture of 2 lots of ALFQ. The containers shall be compatible with QS-21 preferably type 1 glass. The QS-21 shall be shipped under temperature-controlled conditions with 2 temperature monitors.

Period of Performance
01-AUG-2024 TO 31-OCT-2024

Place of Performance
Walter Reed Army Institute of Research (WRAIR), Pilot Bioproduction Facility (PBF), Forest Glen Annex, Building 501, Silver Spring, MD 20910

Overview

Agency
Defense Health Agency (DHA) [DoD]
Response Deadline
June 18, 2024, 11:00 a.m. EDT (original: June 7, 2024, 11:00 a.m. EDT) Past Due
Posted
May 8, 2024, 7:31 a.m. EDT (updated: June 11, 2024, 2:47 p.m. EDT)
Set Aside
None
NAICS
325411 - Medicinal and Botanical Manufacturing
PSC
6505 - Drugs And Biologicals
Place of Performance
Not Provided
Source
Open
Links
Department of Defense Procurement Toolbox
Registration Instructions for the PIEE Solicitation Module
Web Based Training for the PIEE Solicitation Module
PIEE Solicitation Module Link for HT942524Q0047
Current SBA Size Standard
1000 Employees
Pricing
Likely Fixed Price
Est. Level of Competition
Average
Est. Value Range
Experimental
$5,000,000 - $10,000,000 (AI estimate)
On 5/8/24 Defense Health Agency issued Solicitation HT942524Q0047 for Procurement of GMP Manufactured QS-21 due 6/18/24. The opportunity was issued full & open with NAICS 325411 and PSC 6505.
Primary Contact
Name
Nathaniel Reus   Profile
Email
nathaniel.a.reus.civ@health.mil
Phone
(301) 619-9209

Documents

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Additional Details

Source Agency Hierarchy
DEPT OF DEFENSE > DEFENSE HEALTH AGENCY (DHA) > ARMY MED RES ACQ ACTIVITY
FPDS Organization Code
97DH-HT9425
Source Organization Code
500183069
Last Updated
June 11, 2025
Last Updated By
Nathaniel.a.reus.civ@health.mil
Archive Date
June 11, 2025