Human Blood for Research Utilizing Malaria Parasite Cultures

Closed Special Notice Posted

Solicitation number
FY25-0423
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Place of performance
Silver Spring, Maryland, United States

Notice details come from SAM.gov. Updated .

About this opportunity

The Defense Health Agency Contracting Activity (DHACA) R&D Branch 1 has issued a Special Notice announcing its intent to award a sole source contract to ZenBio Inc., located in Durham, North Carolina. This procurement is authorized under 41 United States Code 1901 as implemented in FAR 13.501 and pertains to the supply of human blood products for malaria vaccine research at the Walter Reed Army Institute of Research (WRAIR). The government has identified ZenBio Inc. as the only responsible source capable of meeting its specific requirements for regular, scheduled deliveries of screened human blood products. The contract opportunity falls under the Biological Product Manufacturing category (NAICS 325414) and the Blood and Blood Products category (PSC 6506). The Special Notice was posted on November 10, 2025, with a submission deadline of November 17, 2025.

All human blood products supplied under this contract must comply with stringent regulatory and testing standards, including 21 CFR Part 310.40 General Biological Products Standards Testing Requirements for Relevant Transfusion-Transmitted Infections. Each unit of blood or serum must be FDA certified and accompanied by a Certificate of Analysis, with mandatory testing for HIV types 1 and 2, Hepatitis B and C viruses, HTLV types 1 and 2, Syphilis, Chagas, West Nile virus, and Zika virus. The procurement is designated as non-proprietary, indicating that while this is a sole source award, the government may consider other sources in the future if circumstances change. Due to the specialized nature of the requirements and the sole source determination, only ZenBio Inc. is currently eligible to participate in this procurement. The compressed timeline from posting to due date allows minimal time for interested parties to submit inquiries or protests regarding the sole source justification.

Notice text

The Defense Health Agency Contracting Activity (DHACA) – R&D Branch 1 intends to negotiate on a sole source basis, IAW 41 United Stated Code 1901 as implemented in FAR 13.501 to ZenBio Inc., 3920 Sount Alston Ave, Durham NC 27713, as the only responsible source that can provide the Walter Reed Army Institute of Research (WRAIR), with regular, scheduled, supply deliveries of screened human blood products that meet the Governments requirements  in support of malaria vaccine research.  All human blood products provided will have been tested in accordance with 21 Code of Federal Regulations (CFR) Part 310.40 General Biological Products Standards Testing Requirements for Relevant Transfusion-Transmitted Infections and each unit of blood/serum will be FDA certified and accompanied with a Certificate of Analysis (CoA). The screened human blood products provided must be certified to have been tested, at a minimum, for Human Immunodeficiency virus, type 1, 2 (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), Human T-lymphotropic virus, type I,2 (HTLV), Syphilis (T. pallidum), Chagas (T. cruzi), West Nile virus and Zika virus, in order to meet malaria research requirements.

   

 

Not proprietary.    

Notice history

Notice Type Posted
This notice Latest special notice Special Notice
Human Blood for Research Utilizing Malaria Parasite Cultures Original Pre-Solicitation

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