Center for Biologics Evaluation and Research (CBER) DBPAP/ Amb a 1-Specific Aptamers
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General Information
- Contract Opportunity Type: Solicitation (Updated)
- Updated Published Date: Sep 25, 2024 01:18 pm EDT
- Original Published Date:
- Requirements Strategy:
- Inactive Policy: 15 days after date offers due
- Updated Inactive Date: Oct 12, 2024
- Original Inactive Date:
- Initiative:
- None
Classification
- Original Set Aside:
- Updated Set Aside:
- Product Service Code:
- NAICS Code:
- Place of Performance: Silver Spring , MDUSA
Description
PER AMENDMENT 1 - Proposal Receipt date/time extended to 9/27/2024 at 12:00 pm EST.
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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).
Contact Information
Primary Point of Contact
- Nicholas Bisher
- Nicholas.Bisher@fda.hhs.gov