Development of high-quality blood products from healthy donor animals for testing in nonclinical models of Acute Radiation Syndrome

The Biomedical Advanced Research and Development Authority (BARDA), Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), is issuing this Request for Information (RFI) to collect feedback from current and prospective partners with significant expertise in the development of high-quality blood products from healthy donor animals for transfusion into nonclinical models of Acute Radiation Syndrome (ARS), trauma, or combined trauma and radiation injury. Background: BARDA's mission is to develop medical countermeasures (MCMs) that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents, and attacks; pandemic influenza; and emerging infectious diseases. For lethal exposures to acute radiation, it is not plausible or ethical to test efficacy of products to treat ARS in humans, and field trials to study the effectiveness of products to treat ARS are not routinely feasible; therefore, well-controlled animal studies are needed for these assessments. Mass casualty incidents from various CBRN threats are expected to put additional pressure on the national supply of transfusion blood products used to treat a spectrum of injuries. BARDA is interested in the development of transfusion blood products for the treatment of ARS-associated hemorrhage, vascular injury, and coagulopathy. BARDA has a need for identifying methods for developing transfusion blood products from healthy donor animals for transfusion into nonclinical ARS and other injury models to be able to assess efficacy. The methods for developing transfusion blood products must be reproducible and result in high-quality products to advance towards future in vivo testing. Description: In response to this RFI, respondents should submit a voluntary detailed statement that addresses their capabilities for developing high-quality blood products from healthy donor animals. Where applicable, respondents should include the following information: - Animal species for which the respondent has experience with repeated collection, processing, and analysis of collected blood and/or blood components for transfusion. BARDA is especially interested in respondents experience with the rabbit, minipig, and nonhuman primate (NHP). - Volume, frequency, and technique of blood collection from healthy donor animals. - Established methods of processing blood collected from healthy donor animals to produce transfusible blood products. - Typical yields of transfusion blood products following processing blood. For example, yield characteristics for platelets include platelet yield (platelet count in product x volume of product), platelets processed (platelet count in pooled sample x volume processed), and percent platelet yield ((platelet yield/platelets processed) x 100). - In vitro measurements of the quality, viability, and function of transfusion blood products derived from blood collected from healthy donor animals. - In vivo measurements of quality, viability, and function of blood products once transfused into recipient animals. BARDA is especially interested in experience with evaluating pharmacokinetic parameters of transfused blood products using methods that are also used for human products, such as radiolabeling, biotinylation, or alternative. - Identification of characteristics of blood components in animal models that do not recapitulate to humans, such as species differences in receptors that could affect the ability to make conclusions in translational research. - Information, if available, on sex-based differences in quality, viability, and function of transfusion blood products derived from blood collected from healthy donor animals. - Experience with transferring methods to other institutions (technology transfer). If your institution has substantial experience and capabilities in the development of animal blood products, and is interested in partnering with BARDA, please provide the following information: - Organization name, address, email address, website address, telephone number, and size and type of ownership for the organization. - Current Government Contracts and Schedules or Other Relevant Government Wide Acquisition Contracts (GWAC) or schedule contracts such as GSA. - Response statements tailored to addressing the particulars of this effort as outlined above, with appropriate documentation supporting claims of organizational and staff capability. Responses should be limited to ten pages (or less) and shall be sent electronically to: [Insert contact here] Responses are due no later than 16 February 2024 by 3PM US EDT. DISCLAIMER AND IMPORTANT NOTES This notice is issued solely for information and planning purposes and does not obligate the US Government to award a contract. No entitlement to payment of direct or indirect costs or charges by the US Government will arise because of the submission of the requested information. No reimbursement will be made for any costs associated with providing information in response to this announcement and any follow up information requests. The US Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the US Government to determine the organization's qualifications to perform the work. Respondents are advised that the US Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published on SAM.gov under Contract Opportunities in accordance with FAR part 5. However, responses to this notice will not be considered adequate responses to a solicitation.