The Nonhuman Primate Reagent Resource (NHPRR) develops recombinant biological materials to support research with animal models of human diseases. In our parent P40 award, we produce and distribute approximately 400g of recombinant protein reagents per year. Therefore, we have the tools, expertise, and infrastructure to manufacture recombinant reagents and distribute them widely. Very recently, coronavirus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease (COVID) was declared a pandemic, which prompted the development of new animal models. Unfortunately, the potentially infectious nature of COVID samples has precluded the exchange of reference serum samples among centers developing monkey models of COVID. Thus, our plan is to create safe recombinant reference macaque immunoglobulin standards to facilitate the development and validation of reliable assays for the detection of pathogenic coronaviruses and antiviral antibodies in NHP animal models of COVID. Specifically, this supplement will fund the generation of the following reagents: recombinant coronavirus-reactive rhesus monoclonal IgGs (Aim 1) and NHP serum reference standards (Aim 2). These macaque reference antibody reagents will improve the performance and comparability of antibody-based assays for NHP models by facilitating serum assay development, proficiency training, and inter-laboratory performance comparisons at the NPRCs (see letters of support).
The Nonhuman Primate Reagent Resource develops, manufactures, and distributes research reagents for more than 20 years. We will now leverage our expertise and infrastructure to produce and distribute defined coronavirus-specific monkey immunoglobulin preparations. Our recombinant standard reagents will support the development of rigorous coronavirus-specific antibody assays for nonhuman primate research and colony management.