Custom Large Scale RNA Transcription System

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 with other than full and open competition basis with 
Promega Corporation, Madison, WI 53711
 
NIH has a need for: 
Product needed:
Custom Large Scale RNA Transcription System

AX7650X Large Scale RNA Transcription System, Duke, Custom  Qty: 8 
1 x AX7650X contains:
• AX764X - rNTP Mix, 25mM, rATP, rCTP, rGTP, Custom: 10 x 2000uL
• P132X - Enzyme Mix, T7 Express, Bulk Sale Size: 10 x 500ul
• AX773X - T7 Transcription Buffer, 5X, Bulk Sale Size: 10 x 1000ul 
(4) Shipments with delivery dates: Each shipment = Qty: 2
Shipment 1    Tuesday, July 25, 2023
Shipment 2    Tuesday, October 24, 2023
Shipment 3    Tuesday, February 27, 2024
Shipment 4    Tuesday, May 21, 2024

Delivery location:
NIAID
9 West Watkins Mill Rd
Gaithersburg, MD

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 a accelerated manner, to advance the VRC’s mission. The custom Large Scale RNA Transcription System is required for mRNA production and will facilitate rapid development and ensure success for mRNA-based programs.

The Promega Corporation is the only provider of this custom item required by the Vaccine Research Center (VRC) to implement its available mRNA production technology for clinical development. The kit, which includes nucleoside triphosphates, proprietary buffers and enzymes, has been used successfully for clinical manufacturing by the Duke Human Vaccine Institute (DHVI) at Duke University. The DHVI mRNA manufacturing process, which the VRC has received via a tech transfer agreement with Duke University, is proven to be effective in producing clinical grade material in a scalable and robust manner. Utilizing this custom raw material is imperative to ensure the VRC’s success at both process development and the clinical manufacturing needed to support NIH programs. The requested product will seve as adequate supplies both for development work at the VRC and GMP scale production at the Vaccine Clinical Materials Program (VCMP), and will provide the highest chance of success to meet the VRC’s mission.

The statutory authority for this sole source requirement is 41 U.S.C.1901 (e) (2) 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-23-2172993) to Diana Rohlman at diana.rohlman@nih.gov, by 4:00 pm eastern standard time, June 9, 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.