Good Manufacturing Practice (GMP)-manufactured Monoclonal Antibody
Awarded Limited / Sole Source Justification Posted
- Solicitation number
- JA-NIAID-24-2226773
- Agency
-
National Institute of Allergy and Infectious Diseases
National Institutes of Health, Department of Health and Human Services
- Set-aside
- No set-aside
Opportunity facts
- Contract number
- 75N93024P01131 Federal contract award
- Awardee
- United Biopharma, Inc.
- NAICS code
- 325412 Pharmaceutical Preparation Manufacturing
- PSC
- 6505 Drugs And Biologicals
- Place of performance
- Bethesda, Maryland 20817, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institute of Allergy and Infectious Diseases (NIAID), a division of the Department of Health and Human Services, has issued a Limited/Sole Source Justification Notice to acquire a 100-liter batch of the monoclonal antibody UB-421 from the patent holder and sole manufacturer, United BioPharma. The justification cites United BioPharma as the only responsible source capable of producing this drug due to their proprietary cell line. The total estimated value of the contract is unknown, with a performance period from September 2023 to September 2024. The contracting officer has determined the anticipated price to be fair and reasonable based on a review of similar government purchases.
Notice text
United BioPharma, is the patent holder and manufacturer for UB-421, and the only company that possesses the cell line necessary for its production. As such, United BioPharma is the only known source to produce this drug. Justification document attached.
Awarded contract 75N93024P01131 to unknown vendor for unknown amount on 2024-09-27.
Files
| File | Type | Posted |
|---|---|---|
| JA_United BioPharma_Redacted.pdf |
Notice history
| Notice | Type | Posted |
|---|---|---|
| This notice | Limited / Sole Source Justification | |
| Good Manufacturing Practice (GMP)-manufactured Monoclonal Antibody | Pre-Solicitation | |
| Good Manufacturing Practice (GMP)-manufactured Monoclonal Antibody | Pre-Solicitation |
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