Qualification service for MSD Sector S600 Reader and Assay Plates Supplies for MSD Reader

PRE-SOLICITATION NOTICE ** NOTICE OF INTENT NOI-NIAID-24-2210092 NAICS – 325414, Biological Product Mfg 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 Meso Scale Discovery (MSD), a division of Meso Scale Diagnostics, LLC of Rockville, MD to procure MSD-brand assay plates for direct use in existing MSD reader system, as well as vendor qualification of the MSD SECTOR S600 Reader utilized by the NIH Vaccine Research Center (VRC) Vaccine Immunology Program (VIP) to perform assay testing in support of assay testing in support of therapeutic antibody isolation and development projects.

IQ/OQ/PQ of the instrument MSD SECTOR S600 Reader U-PLEX Development Pack, 10-Assay SECTOR Plate (25 Pl) MULTI-ARRAY® 96 Plate Pack (300 Plate) MA6000 384 Plate Pack (120 Plate) The Vaccine Immunology Program (VIP) aids the Vaccine Research Center (VRC) by supporting the development of monoclonal antibodies and vaccines for infectious diseases such as HIV, Influenza, Ebola, and more recently SARS-CoV-2 Coronavirus.

Support is through the state-of-the-art laboratory performing Phase 1 and Phase 3 clinical end point testing to inform further study designs, research questions and vaccine modification and design. As the threat of emerging respiratory viruses continues in the international community, the need for a safe and efficacious monoclonal antibody therapy at an accelerated timeline is a health care priority.

To assist in this effort, the VIP/PREMISE will use the electrochemiluminescent (ECL) assay format which they have developed through Meso Scale Discovery (MSD) for the detection of specific antibodies directed towards a panel of respiratory virus spikes/glycoproteins. These proteins are 'printed' or 'spotted' in a single well of an MSD 96-well microtiter plate.

The VIP/PREMISE identified the ECL assay as the most reliable and sensitive assay system over the last 10 years, that offers high dynamic range in the detection of specific serum antibodies generate towards a variety of viral proteins. The platform offers extremely high throughput for the simultaneous measurement of antibodies to their epitopes.

Since the multi-plex assays used for Ph1 and Ph3 testing is on the MSD platform, it is very logical to also develop the 10-plex assays on the same platform for ease of testing and familiarity of the technology and utilization of the current instruments in the lab. MSD are the sole owners of the intellectual property of the ECL assay designed in collaboration with VIP/PREMISE specifically for screening of respiratory monoclonal antibodies. 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-24-2210092), and must prove their capability to provide the above-mentioned products/services, to Dana Monroe at dana.monroe@nih.gov, by 5:00pm eastern time February 6, 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.