STANDING ORDER FOR LABORATORY SUPPLIES

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 Sartorius Corporation located for laboratory supplies.

The VRC/Vaccine Production Program (VPP) group is responsible for developing a scale able GMP process 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. VPP is requesting the Cell Line Development and Cell Culture Development supplies in support of the VPP’s therapeutic and vaccine candidates.

The items ordered herein fall into two categories: 1) They are specific to an instrument that require the specific items listed in section F to be from this manufactured by the requested manufacturer and/or 2) these items have historical applications and have already proven to be effective with our specific biological candidates, are currently under VPP’s Cell Culture and 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 re validated existing materials at the pilot plant. This would then cause significant (greater than 12 months) delays in the VRC’s program goals.

The statutory authority for this sole source requirement is 41 U.S.C. 253 (c) (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-24-2229342 in the eSASS system, by 12:00 pm eastern standard time August 8, 2024. All quotations and required documents must be submitted via the NIAID electronic Simplified Acquisition Submission System (eSASS) website at https://esass.nih.gov. All vendors must register in the eSASS system to submit a quotation.

Instructions on how to register / submit quotes are included on the website. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). All responsible sources may submit an offer that will be considered by this Agency.