• Research Category Research & Development Services & Subcontracts
• Vendor Name Leidos Biomedical Research, Inc.
• Solicitation Number S24-064
• NCI OA Contract Number 75N91019D00024 – NCI-FFRDC

Description

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 vaccine candidates. This includes completion of reports and documentation that will enable regulatory filing, and evaluation of the vaccine candidate in DMID’s NextGen clinical trial. In support of one vaccine candidate, Leidos Biomed seeks to contract with a Contract Research Organization (CRO) for bioburden, sterility testing, and appearance of aliquots and single-dose vials containing the vaccine candidate, which will be used in a US-based Phase 1 clinical trial.

In support of this effort, the Subcontractor will be provided with aliquots from engineering and clinical runs of five (5) different formulated bulks from the India-based vaccine manufacturer for bioburden testing. The Subcontractor will also be provided with single dose vials from engineering and clinical runs of five (5) different drug product formulations from a US-based fill & finish Contract Development and Manufacturing Organization (CDMO) for sterility, appearance, and subvisible particle tests at several stability timepoints.

Leidos Biomed is seeking a US-based Subcontractor to provide bioburden and sterility testing services for a messenger Ribonucleic Acid (mRNA) vaccine encapsulated in lipid nanoparticles (mRNA-LNP) 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.

The Subcontractor shall provide all necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by Leidos Biomed or NIAID DMID. Subcontractor shall conduct tasks in accordance with all applicable host country, federal, state, and local laws, codes, ordinances, and regulations.

Proposal Instructions

Questions and request for clarifications are due no later than 3:30 PM (EST) WEDNESDAY SEPTEMBER 25, 2024, and offer submissions are due no later than 3:30 PM (EST) WEDNESDAY OCTOBER 2, 2024. Please reach out to Mario Salerno at mario.salerno@nih.gov, to receive the Request for Proposal package containing additional detail & instruction.