A02. Request for Information Cryoplateable Hepatocytes IDIQ.pdf

SUBJECT: Cryoplateable Hepatocytes IDIQ

REQUIRING ACTIVITY NAME: Walter Reed Army Institute of Research (WRAIR), Viral Diseases Program (VDP)

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 REQUEST FOR INFORMATION (RFI). NO CONTRACT WILL BE

AWARDED PURSUANT TO THIS ANNOUNCEMENT.

DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. 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.

RFI AVAILABILITY: In accordance with FAR Part 10 Market Research, this RFI is to ensure responsible and constructive exchanges with industry while complying with existing law and regulation that does not provide an unfair competitive advantage to particular firms or violate the procurement integrity requirements.

This RFI is being made available through the following platforms to maximize market research to target Prime Contractors to perform:

• SAM.Gov

• General Services Administration (GSA)

CAPABAILITY STATEMENT INSTRUCTIONS: Interested parties are asked to respond to this RFI and submit a capabilities statement that supports the focus of this RFI. Please review the Draft Minimal Essential Characteristics in the next section and submit written responses via email in Microsoft Office or PDF format. All responses should be complete: in 12-point font; and not to exceed 5 pages total, including graphics, tables, and appendices.

No hardcopies shall be accepted. No written solicitation document is available at this time.

Telephone requests will not be honored, and no bidders list shall be maintained.

• FOR GSA: Capability Statements must provide confirmation that this requirement Material Essential Characteristics involving Cryoplateable Hepatocytes is currently on your schedule for GSA.

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 Jaclyn.p.svincek.civ@health.mil and Patrick.k.harris18.civ@health.mil no later than 10:00AM EST on Monday, 14 July 2025.

REQUIREMENT AND FOCUS AREA

Material Essential Characteristics (MECs)

Cryoplateable Hepatocytes IDIQ

ESTIMATED PERIOD OF PERFORMANCE:

The periods of performance for this contract are as follows:

Five Year Ordering Period 15 December 2025 – 14 December 2030

Deliver human and monkey cryoplateable hepatocytes for the WRAIR Viral Diseases Program meeting the following MECs:

1. Must have validated proof of being cryoplateable on a 384-well microplate. Hepatocytes should have at least 75% viability when thawed and be able to be immediately transferred to a microtiter plate with high levels of adherence of to the plate. Die off of the hepatocytes upon plating must be minimal to ensure a confluent monolayer across the plate wells.

2. Must have validated proof that cryolateable can support high malaria liver-stage infection of all malaria species to include but not limited to P. Cynomolgi. Additionally, hepatocytes must show the ability to be infected with viral diseases, to include but not limited to flaviviruses (Dengue, Zika, Yellow Fever, West Nile).

3. Must have at a minimum 100 vials of a single donor to be considered for purchase.

Additionally, must have available at least 5 different donors of validated monkey hepatocytes lots that have shown infectivity with infectious diseases in order to ensure enough vials are available to meet the contract.

4. Provide up to 250 vials/year of Rhesus macaque or cynomolgus macaque monkey cryoplateable hepatocytes individual, greater than 5 million hepatocytes per vial with quarterly shipments. Choice of Rhesus macaque or cynomologus macaque will be stated on each call order.

5. Provide up to 100 vials/year of human cryoplateable hepatocytes individual, greater than 5 million hepatocytes per a vial, with quarterly shipments.

6. Vendor will provide pricing for a 5-year ordering period.

7. Hepatocytes will be shipped with next day delivery in a liquid nitrogen cryoshipper containing a temperature monitor to ensure the shipper stays within temperature range (- 150°C or colder) throughout the entire shipment process which will ensure hepatocytes remain frozen. Hepatocytes will be shipped to the below listed location:

Walter Reed Army Institute of Research (WRAIR) 503 Robert Grant Ave, Room 2N64 Silver Spring, MD 20910

8. Orders for hepatocytes will be submitted by either delivery order or government purchase card (GPC). GPC orders will be routed through WRAIR Logistics for purchase and placed by: (TBD At time of Award).

9. Hepatocyte Lot Qualification and Acceptance Criteria: Prior to purchase, each lot of primary human and monkey hepatocytes provided must undergo in-house evaluation by the Walter Reed Army Institute of Research (WRAIR), Integrated Pathogen Therapeutics (IPT) Department to assess suitability for malaria liver-stage infection studies. This testing requirement is essential to ensure experimental reproducibility and reliability in malaria liver-stage drug screening workflows. Specifically:

• Test Material: Vendor shall provide a test vial (or equivalent aliquot) from each prospective lot for evaluation by WRAIR.

• Evaluation Metrics: WRAIR will assess:

- Plateability: the ability of the hepatocytes to form a consistent monolayer under standard culture conditions

- Infectivity: The lot’s permissiveness to Plasmodium sporozoite infection, determined via IPT’s validated in vitro assay.