Center for Biologics Evaluation and Research (CBER) DBPAP/ Amb a 1-Specific Aptamers
Closed Solicitation Posted
- Solicitation number
- 75F40124Q00548
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- Total Small Business
Opportunity facts
- NAICS code
- 325414 Biological Product (except Diagnostic) Manufacturing
- Place of performance
- Silver Spring, Maryland, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The U.S. Food and Drug Administration (FDA) is seeking the development of Amb a 1-specific capture and biotin-labeled detection aptamers for use in Enzyme Linked Immunosorbent Assay (ELISA)/ImmunoEnzymetric Assay (IEMA) to measure the biological potency of commercial ragweed pollen extracts marketed in the United States. The 100% small business set-aside solicitation is for a firm-fixed-price contract with a one-year period of performance. Vendors must submit quotes by September 27, 2024, and the award will be made on a lowest price, technically acceptable basis. The statement of work outlines a 3-phase technical approach, including preliminary screening, selection, and screening/characterization of the aptamers.
This opportunity is set aside for small businesses. The place of performance is Silver Spring, MD. The total value of the contract is $194,740, broken down into 4 deliverables under Phase I and Phase II. The key deliverables include submitting a draft study protocol, ICF, and implementation plan; submitting an IRB application package; submitting relevant study documents; and obtaining local IRB approval.
Notice text
2 versions
Update #2 · Latest ·
PER AMENDMENT 1 - Proposal Receipt date/time extended to 9/27/2024 at 12:00 pm EST.
_________________________________________________________________________________
Introduction
Development of Amb a 1- Specific capture and biotin-labeled detection Aptamers for use in Enzyme Linked Immunosorbent Assay (ELISA)/ImmunoEnzymetric Assay (IEMA)
Background
In the United States ragweed allergen extracts are standardized, which means that their potencies are determined in comparison to a US Reference Standard. Potency of the extract is determined by measuring Amb a 1 content. The Laboratory of Immunobiochemistry (LIB) needs to develop reference standard Amb a 1-specific capture and biotin-labeled detection monoclonal aptamers suitable for use in Enzyme Linked Immunosorbent Assay (ELISA)/ImmunoEnzymetric Assay (IEMA) to measure biological potencies of commercial ragweed pollen extracts marketed in the United States.
Scope
Amb a 1-specific capture and biotin-labeled detection monoclonal antibodies suitable for use in Enzyme Linked Immunosorbent Assay (ELISA)/ImmunoEnzymetric Assay (IEMA).
Update #1 ·
Introduction
Development of Amb a 1- Specific capture and biotin-labeled detection Aptamers for use in Enzyme Linked Immunosorbent Assay (ELISA)/ImmunoEnzymetric Assay (IEMA)
Background
In the United States ragweed allergen extracts are standardized, which means that their potencies are determined in comparison to a US Reference Standard. Potency of the extract is determined by measuring Amb a 1 content. The Laboratory of Immunobiochemistry (LIB) needs to develop reference standard Amb a 1-specific capture and biotin-labeled detection monoclonal aptamers suitable for use in Enzyme Linked Immunosorbent Assay (ELISA)/ImmunoEnzymetric Assay (IEMA) to measure biological potencies of commercial ragweed pollen extracts marketed in the United States.
Scope
Amb a 1-specific capture and biotin-labeled detection monoclonal antibodies suitable for use in Enzyme Linked Immunosorbent Assay (ELISA)/ImmunoEnzymetric Assay (IEMA).
Files
| File | Type | Posted |
|---|---|---|
| 75F40124Q00548 Amendment 1_ 9-25-2024.pdf | ||
| 75F40124Q00548 9-19-2024.pdf | ||
| Attachment A - Pricing Worksheet.xlsx | XLSX spreadsheet | |
| Attachment B- RFQ Question Submittal Form.xlsx | XLSX spreadsheet |
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