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 TriLink Biotechnologies, located at 10770 Wateridge Cir. Ste 200, San Diego, CA 92121 for N1-Methyl-Pseudoridine-5-Triphosphate and CleanCap Reagent AG reagents.

The National Institute of Allergy and Infectious Diseases (NIAID), requires the reagents. The mRNA technology is a current and attractive alternative for the development of Human vaccines. The target protein gene sequence is encoded in a template DNA plasmid containing a T7 RNA polymerase promoter required for RNA transcription. mRNA transcripts are produced from a linear DNA template during an in vitro transcription (IVT) reaction. The resulting mRNA is subsequently purified, formulated in lipid nanoparticles, and delivered into cells to be translated into the protein of interest. The mRNA production process that the Vaccine Research Center will implement for vaccine development has been transferred from Duke University to the Downstream Process Development (DPD) Team at the VRC. The DPD team will utilize this technology transfer to develop novel mRNA vaccines against human diseases, in an accelerated manner, to advance the VRC’s mission under a POP of August 23 to August 24. The custom Large Scale RNA Transcription System is required for mRNA production and will facilitate rapid development and ensure success for mRNA-based programs. VPP requests receiving these supplies in 4 shipments.

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-2177305 to Maliaka Pinkney at maliaka.pinkney@nih.gov, by 12:00 pm eastern standard time August 18, 2023. 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.

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