ROCHE DIAGNOSTICS REAGENTS
Waiver type - Procurement: Nonavailability
Agency: NATIONAL INSTITUTES OF HEALTH (7529) • Product Service Code (PSC) : 6509 | Last Modified: 08/15/2023
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.
Waiver Rationale Summary
Conclusion: Based on the above market research findings and results from the brand name or equal request for quotes RFQ-NIAID-23-2178340 posted on SAM.gov, no domestic products that meet the requirements were available. No domestically manufactured items that meet the Government’s need that are mined, produced, or manufactured in the United States in sufficient and reasonably available commercial quantities and of satisfactory quality could be identified. Only one company responded to the solicitation (Request for Quotes), which was posted as full and open competition with a brand name or equal requirement, and that was Roche Diagnostics. The feasibility of foregoing the requirement or providing a United States-manufactured substitute has been considered, and no substitutes were found. Authority is requested to acquire the above-described library preparation reagents manufactured in Germany by Roche Diagnostics at the total cost of $11,346.00. Based on the findings detailed above, the Roche Diagnostics reagents are not mined, produced, or manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. Therefore, it is hereby determined by NIAID, consistent with FAR 25.103(b)(2), that these items are nonavailable.
Yes
No
Consistent with Policy
DRUGS AND BIOLOGICALS, VETERINARY USE
325414 - Biological Product (except Diagnostic) Manufacturing
08/14/2023
RFQ-NIAID-23-2178340
Post-solicitation
0 - 6 months
Individual Waiver
NATIONAL INSTITUTES OF HEALTH