B01- Notice of Intent to Sole Source ALFQ 55.pdf
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- Attached to
- Procurement of GMP Manufactured ALF55
- Solicitation number
- HT942524R0064
- Issued by
-
Defense Health Agency
About this file
This document is a Notice of Intent to Sole Source for the procurement of 2.75 liters of GMP-manufactured Army Liposome Formulation containing 55 mol% cholesterol (ALF55) by the U.S. Army Medical Research Acquisition Activity (USAMRAA) on behalf of the Walter Reed Army Institute of Research (WRAIR). The ALF55 is required to create two new lots of Army Liposome Formulation with QS-21 saponin (ALFQ) for the Military HIV Research Program (MHRP). USAMRAA intends to negotiate a sole source contract with Avanti Polar Lipids Inc., the only approved vendor, under FAR 6.302-1. Avanti Polar Lipids Inc. has provided this compound twice in the past with satisfactory quality and is vetted and found acceptable by the FDA. A change of vendor would require substantial cost for qualifying a new vendor and testing the product. Interested parties may submit capability information by 2:00 p.m. EST on April 12, 2024, but the government retains sole discretion on whether to compete the proposed procurement.
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Text version
Notice of Intent to Sole Source
Date: 28 March 2024
Contracting Office Address – US Army Medical Research Acquisition Activity (USAMRAA), 808 Schreider Street Fort Detrick, MD 21702
Subject: Notice of Intent to Sole Source – Procurement of GMP Manufactured ALF55, Walter Reed Army Institute of Research (WRAIR)
Solicitation Number: HT942524R0064
The United States Army Medical Research Acquisition Activity (USAMRAA) intends to negotiate on a sole source basis IAW FAR 6.302-1 with vendor Avanti Polar Lipids Inc
This requirement is to purchase 2.75 liters of the compound Army Liposome Formulation (ALF) containing 55 mol% cholesterol (ALF55) is required for the MHRP, WRAIR to create two new lots of Army Liposome Formulation with QS-21 saponin (ALFQ). The ALF55 shall be manufactured by current Good Manufacturing Practices (cGMP).. formulation includes monophosphoryl 3-deacyl lipid A (3D-PHAD®). This synthetic lipid is trademarked and owned by Avanti Polar Lipids Inc., under patent number 9,241,988. This vendor provided this compound twice in the past, with satisfactory quality. This vendor is vetted and found acceptable by the Food and Drug Administration (FDA). A change of vendor would require a substantial cost burden for us to qualify a new vendor and test the product. For this effort we need to keep the manufacturing method the same.
Objectives
The vendor shall be certified prior to acquisition. This process requires the vendor to answer quality questions on GMP compliance and manufacturing. The vendor shall be required to agree to a quality agreement with the Office of Regulatory Affairs (ORA) and WRAIR. It also requires ORA and WRAIR personnel to visit manufacturing site for up to three days to conduct the quality certification process. The vendor will be required to provide manufacturing information to ORA and WRAIR for inclusion in the ALFQ master file or provide the information through a letter of cross-reference to the vendor master file.
The manufacturer will need to provide data demonstrating the that ALF55 meets the ALF55 specifications.
THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE QUOTATIONS.
Responsible, interested parties may identify their interest by submitting capability information, in writing, by 2:00 p.m. est. 12 April 2024 to Mr. Nathaniel Reus at Nathaniel.a.reus.civ@health.mil.
Supporting evidence must be furnished in sufficient detail to demonstrate the firm’s ability to provide the stated capability.
Responses will be evaluated; however, a determination by the Government not to compete the proposed procurement based upon responses to this notice is solely within the discretion of the Government. If no responses are received, USAMRAA will proceed with the sole source contract.
mailto:Nathaniel.a.reus.civ@health.mil
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