House Dust Mite Antibody Sets to Standardize Allergen Extracts
Closed Solicitation Posted
- Solicitation number
- 75F40126Q00378
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Place of performance
- Silver Spring, Maryland 20993, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The Food and Drug Administration Office of Acquisition and Grant Services seeks monoclonal antibody sets to standardize house dust mite allergen extracts, with quotations due September 8, 2026, at 2:00 p.m. Eastern Time. This is a full and open competition acquisition under FAR Part 12 for commercial products with a Firm Fixed Price contract.
Place of performance is Silver Spring, Maryland. The FDA's Center for Biologics Evaluation and Research requires six antibody pairs formatted for ELISA use: Der p 1, Der p 2, and Der p 23 (Dermatophagoides pteronyssinus) and Der f 1, Der f 2, and Der f 23 (Dermatophagoides farinae). Quantities must be sufficient for 225 96-well microtiter plates for each allergen group. While some antibody sets may be group-specific across species for cost efficiency, at least one allergen group must have species-specific antibodies to prevent inadvertent extract switching. Deliverables are due 60 days after award in liquid format at 4°C or frozen. Suppliers must provide data demonstrating fitness for purpose, adequate sensitivity, and appropriate species specificity.
The NAICS code is 541715 (Research and Development in Physical, Engineering, and Life Sciences), and the PSC code is AC23 (Applied Research-Health Sciences). Evaluation prioritizes technical capability and approach first, followed by past performance in house dust mite allergen extract characterization, ELISA development, and immunological reagent supply, with price evaluated for reasonableness and realism. The Government reserves the right to award without discussions. Quotations must include a technical approach (50-page maximum) and a price/business proposal with basis of estimate and representations/certifications.
Notice text
See attached RFQ
Files
| File | Type | Posted |
|---|---|---|
| RFQ 75F40126Q00378.pdf |
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