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.

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.