Inactive

PRE-SOLICITATION NOTICE **NOTICE OF INTENT NOI-NIAID-24-2224326 NAICS – 334516 This is a Notice of Intent, not a request for proposal. The National Institute of Allergy and Infectious Diseases (NIAID)... PRE-SOLICITATION NOTICE **NOTICE OF INTENT NOI-NIAID-24-2224326 NAICS – 334516 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 MaxCyte Inc to procure a Maxcyte ExPERT STx Flow Electroporation Platform Generation 3 system. Maxcyte will provide a one-year warranty, technical support, installation, training, and ongoing technical assistance. The Cell Line Development Team at the Vaccine Production Program (VPP) of the Vaccine Research Center (VRC) is responsible for generating clonally-derived cell lines expressing monoclonal antibodies and vaccine candidates that will be used for clinical manufacturing. Additionally, the team generates material using transient expression and stable pool generation processes that provide reagent-grade material to support pre-clinical and clinical studies. These processes all begin with transfection of a mammalian cell line with plasmid DNA encoding the protein of interest. Efficient transfection requires significant optimization of the transfection method and conditions to ensure high transfection efficiency and cell viability. The MaxCyte STx scalable transfection system is a validated platform for cell transfection using flow electroporation. It enables rapid and efficient transfection of multiple cell types with a variety of molecules at various scales without specific reagents. The MaxCyte STX operates as a sterile, closed system that provides unparalleled consistency, flexibility, scalability, and loading efficiency. It offers the ability to transfect cells at scales ranging from 75 thousand to 20 billion cells. Currently the VPP uses an older model of this instrument to initiate all CLD processes including transient protein production, stable pool generation, and single cell cloning. The VPP has optimized protocols to ensure high transfection efficiency and cell viability. The scalability of the instrument is unique and allows the program to consistently transfect cells at various scales depending on the material need. After 10 years of reliable use, the VPP is beginning to experience intermittent issues with the instrument. Acquiring the newer model will allow the VPP to have a seamless transition and continue to use all existing SOPs without impact to their processes as the core technology of the instrument remains the same. Changing to a different instrument or transfection method would require significant redevelopment and would be likely to significantly impact the project timelines, efficiency, and production levels. 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-24-2224326) to Dana Monroe at dana.monroe@nih.gov by 5:00 pm eastern time Wednesday, June 26, 2024. 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.