ROCHE DIAGNOSTICS REAGENTS

Procurement Summary

The Vaccine Research Center (VRC) is an intramural research center within NIAID dedicated to discovery and translational science for infectious disease indications. The VRC has full bench-to-bedside capabilities that enable rapid clinical evaluation of VRC discoveries. The VRC’s Vaccine Production Program Laboratory has process (VPPL), formulation, and analytical development groups and oversees cGMP manufacturing at the VRC’s pilot plant. The VRC has full bench-to-bedside capabilities that enable rapid clinical evaluation of VRC discoveries. The Vaccine Research Center (VRC), Vaccine Production Program Laboratory (VPPL) is responsible for developing scalable vaccines following the GMP process and the items requested need to be standardized with what will be utilized in the VRC’s pilot plant and applicable to a GMP process and analytical standards that are used to characterize and release therapeutic and vaccine candidates to treat diseases including Covid-19 (SARS2-CoV), HIV, Influenza, Malaria, and Ebola. Understanding these attributes are required for moving forward with a candidate to GMP manufacturing and clinical trials. The VPPL is requesting the above referenced reagents that are manufactured by Roche Diagnostics for use in our long-standing clinical and research projects, as well as vaccine development projects. These reagents are required to be compatible with Roche Diagnostic instruments. Missions need for the item(s) are intended to satisfy the need for: These reagents are targeted enrichment reagents. They are specific to the existing Roche Diagnostics instrument currently in use that requires compatible reagents. The listed reagents are the only known compatible reagents. These items have historical applications and have already proven to be effective with our specific biological candidates, are currently under VPP’s Cell Line Development SOPs. Additionally, the instruments for which these supplies are being requested are currently in use at the GMP Pilot plant and are currently validated in their process. Attempts to modify the items the VPP utilities in the development of the next generation vaccine and or therapeutics would result in the pilot plant having to re tool and then revalidated existing materials at the pilot plant.

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