B01 - RFI - Human Blood Samples.docx

Subject: Human Blood for Research Utilizing Malaria Parasite Cultures

Requiring Activity Name: Walter Reed Army Institute of Research (WRAIR), Biologics Research and Development (BR&D) Branch

THIS IS NOT A REQUEST FOR PROPOSALS (RFP) OR A REQUEST FOR QUOTATIONS (RFQ); IT IS STRICTLY A REQUEST FOR INFORMATION (RFI). NEITHER UNSOLICITED PROPOSALS NOR ANY OTHER KINDS OF OFFERS WILL BE CONSIDERED IN RESPONSE

TO THIS RFI. NO CONTRACT WILL BE AWARDED PURSUANT TO THIS ANNOUNCEMENT.

1.0 DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. All information received in response to this RFI that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future RFP will not be entertained.

2.0 SUBJECT: This is a summary of the tasks required for this requirement.

The purpose of this requirement is to supply the Biologics Research and Development (BR&D) Branch with screened human blood products. Human blood products are required for in vitro culture of human malaria parasites. The WRAIR, BR&D Branch cultures Plasmodium falciparum human malaria parasites for research studies. This includes the following:

a) All blood products shall be collected in the United States of America from human donors in Food and Drug Administration (FDA) registered and/or licensed centers and tested at an FDA certified, registered, and/or licensed lab using screening tests that FDA has licensed, approved, and/or cleared for such use, in accordance with the manufacturer’s instructions.

b) All blood products shall be tested in accordance with 21 CFR part 610.40 General Biological Products Standards Testing Requirements for Relevant Transfusion-Transmitted Infections and yield non-reactive/negative results for each test performed on each unit.

c) All blood products shall be accompanied by a Certificate of Analysis (COA) certifying the results of all required tests as negative or non-reactive for each unit received.

d) The minimum required tests include:

1. HIV (Human immunodeficiency virus, type 1, 2)

2. HBV (Hepatitis B virus)

3. HCV (Hepatitis C virus)

4. HTLV (Human T-lymphotropic virus, type I,2)

5. Syphilis (T. pallidum)

6. Chagas (T. cruzi)

7. West Nile virus

8. Zika virus

9. Donors will be screened or questioned for history of CJD and vCJD (Creutzfeldt-Jakob disease) and malaria. The COA will note that the risk factor or response is acceptable.

e) The collection date and expiration date for each unit (identified by ID or lot number) shall be included on the COA. If the dates are compiled on a packing list or invoice instead of on individual unit COAs, the units and dates shall be clearly linked to the relevant COA.

f) All blood products shall be packaged on wet ice (not frozen) in a manner to maintain a temperature in transit of 1-10oC. Whole blood or red blood cells will be shipped no later than 5 days after donation. Serum shall be shipped no later than 7 days after donation (serum as liquid, never frozen).

g) The blood products shall arrive via Priority Overnight or Next-Day Delivery, for delivery in the morning.

h) Donors shall not have taken antimalarial drugs in the 4 months prior to donation, nor aspirin within the previous 4 days prior to donation.

i) Donors shall be negative for sickle cell anemia.

j) Blood shall be collected with CPDA-1 anticoagulant. Serum will be collected off-the-clot.

3.0 RESPONSE INSTRUCTIONS: Respondents should address the Offeror's capabilities to provide the services to meet the requirements detailed in section 2.0 above.

4.0 CAPABAILITY STATEMENT FORMAT: Contractor’s capability statements are limited to 15 pages. The response shall be single spaced. Each paragraph shall be separated by at least one blank line. A standard, 12-point minimum font size applies. Times New Roman font is required. Tables and illustrations may use a reduced font size no less than 8-point and may be landscape. The cover page does not count in the page count.

5.0 ESTIMATED PERIOD OF PERFORMANCE: November 2025 – November 2030

6.0 CONTACT INFORMATION: No questions will be addressed. All information regarding Capabilities Statements or any other proprietary information relative to this RFI shall be submitted via email to joshua.r.dean2.civ@health.mil no later than 11:00am EST on Friday, 12 September 2025.