Inactive

PRE-SOLICITATION NOTICE NOI-NIAID-2060738 NAICS – 334516 This is a Notice of Intent, not a request for proposal. The National Institute of Allergy and Infectious Diseases (NIAID) of the National Insti... PRE-SOLICITATION NOTICE NOI-NIAID-2060738 NAICS – 334516 This is a Notice of Intent, not a request for proposal. The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) intends to negotiate on an other than full and open competition basis with Rheosense, Inc to procure a Rheosense Initium VROC One Plus Viscometer. The Initium VROC One Plus is an automated viscometer that enables high-throughput screening and requires less material compared to conventional viscometers/rheometers. High-throughput screening enables more stabilizing excipients to be tested earlier in formulation development. Additionally, screening formulations at multiple temperatures, like those at cGMP manufacturing sites and the clinic, helps avoid temperature-dependent viscosity issues that may arise during vaccine production or administration. This helps avoid potential development delays as well as clinical administration failures due to unacceptably high drug product viscosity. Acquisition of the Initium will decrease formulation development timelines as well as decrease potential failure at the manufacturing site or clinic. The NIH Vaccine Production Program requires the RheoSense Initium VROC Plus One. The Rheosense Initium is the only high-throughput, low volume viscometer/rheometer on the market. The autosampler can accommodate a 40-vial configuration or a standard 96 well plate. The Initium requires a minimum of 26 µL of material for analysis. The Initium can perform multiple viscosity measurements ranging from 0.3 -1000 cP, at various shear rates ranging from 40 – 140,000 s-1, on a single injection; this is not possible on other traditional plate and cone rheometers. The temperature range of the Initium from 4°C - 70°C, enables temperature-dependent viscosity profiles of drug substance and drug product at temperatures experienced at cGMP manufacturing sites as well as at clinic The Initium also recovers and retrieves tested samples; this feature is unique to this autosampler VROC system. The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL. All responsible sources that could provide comparable services may submit a capability statement that will be considered by email (subject line to reference NOI-NIAID-2060738 to Dana Monroe at dana.monroe@nih.gov by 5:00pm eastern standard time Tuesday, March 2, 2021. All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.