DMID NextGen Nanofiltration, Fill and Finish

Solicitation
Person of Contact Kimberly A. Iman (kimberly.iman@nih.gov)
Proposal Due Date Thursday, June 18, 2026 (Due in 1 week)
NAICS Codes 541714
  • Research Category Research & Development Services & Subcontracts
  • Solicitation Number S26-125
  • NCI OA Contract Number 75N91019D00024 – NCI-FFRDC

Description

NIAID DMID’s objective is to initiate and execute the clinical trial provisionally entitled “A Platform Trial to Evaluate Next Generation COVID-19 Vaccines”, and referred to as NextGen, which is a series of standardized phase 1 and phase 2 trials on next-generation vaccines to generate data to inform decisions on which candidates to support for advanced development.

In support of the NIAID DMID NextGen clinical trials, Leidos Biomed is tasked with the management, oversight, and conduct of activities to support customized gap-filling for the vaccine candidate. This includes completion of reports and documentation that will enable regulatory filing, and evaluation of the vaccine candidate in a phase 1 clinical trial. In support of one vaccine candidate, Leidos Biomed seeks to contract with a Contract Development and Manufacturing Organization (CDMO) with the capabilities to perform nanofiltration processing followed by fill and finish of a recombinant protein vaccine for the prevention of SARS-CoV-2 generated from the 1c-SApNP® platform (CHO Expression System). The filled, finished, and tested drug product is intended for use in a US-based Phase 1 clinical trial. The Offerors shall provide nanofiltration, fill and finish, and release testing.

Offerors shall be a US-based CDMO to provide nanofiltration, fill/finish, and release testing services for a 1c-SApNP® platform recombinant protein vaccine candidate for use in a US-based Phase 1 clinical trial. Services shall be conducted in accordance with current Good Manufacturing Practices (cGMP) and all applicable US Pharmacopeia (USP) standards.

Proposal Instructions

Please request the RFP Solicitation Package from Kimberly Iman at kimberly.iman@nih.gov. Proposal due date is Thursday, June 18, 2026, at 4PM ET, questions must be emailed to Kimberly Iman at kimberly.iman@nih.gov by 4PM ET Tuesday, June 2, 2026.

Amendment No. 01 issued to change the questions due date from 4PM ET Tuesday, June 2, 2026, to 4PM ET Friday, June 5, 2026. All questions must be emailed to Kimberly Iman at kimberly.iman@nih.gov.

Amendment No. 02 is issued to rescind Solicitation/RFP S26-125 effective immediately. Therefore, this RFP is hereby cancelled.