U-plex development pack, 10-assay sector plate

Closed Pre-Solicitation Posted

Solicitation number
NOI-NIAID-24-2211384
Agency
National Institute of Allergy and Infectious Diseases National Institutes of Health, Department of Health and Human Services
Responses due
Set-aside
No set-aside

Opportunity facts

NAICS code
325414 Biological Product (except Diagnostic) Manufacturing
PSC
6505 Drugs And Biologicals
Place of performance
Gaithersburg, Maryland 20878, United States

Notice details come from SAM.gov. Updated .

About this opportunity

The National Institute of Allergy and Infectious Diseases intends to procure U-PLEX Development Pack, 10-Assay SECTOR Plates from Meso Scale Discovery to support assay testing conducted by the Vaccine Research Center's Vaccine Immunology Program. The Program aids in developing monoclonal antibodies and vaccines for diseases including HIV, influenza, Ebola, and SARS-CoV-2. The plates will be used in the Program's existing MSD reader system. Responses to the Notice of Intent are due by February 15, 2024. Only Meso Scale Discovery will be considered as they own the intellectual property for the electrochemiluminescent assay designed specifically for the Program's respiratory monoclonal antibody screening.

There is no set-aside designated. Meso Scale Discovery is the potential incumbent as the sole owner of the assay technology. The agency intends to procure 5 units of the U-PLEX Development Pack at a total estimated value of $12,375 to support the Program's work developing therapeutic monoclonal antibodies and vaccines at its Gaithersburg, Maryland location on an accelerated timeline due to public health priorities regarding emerging respiratory viruses.

Notice text

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 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.

1) U-PLEX Development Pack, 10-Assay SECTOR Plate (25 Pl) CAT # K15235N-4  QTY: 5 
2) Shipping and Handling 

LOCATION:  
NIH/NIAID
9 West Watkins Mill Road
Gaithersburg, MD 20878

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-24-2211384), and must prove their capability to provide the above-mentioned products/services, to Diana Rohlman at diana.rohlman@nih.gov, by 4:00pm eastern time February 15, 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.
 

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