SOLICITATION NOTICE
65 -- ANTI-ANTHRAX TOXIN ANTIBODY, Obiltoxaximab
- Notice Date
- 9/14/2023 8:38:44 AM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- FDA OFFICE OF ACQ GRANT SVCS Beltsville MD 20705 USA
- ZIP Code
- 20705
- Solicitation Number
- FDA-23-1268057
- Response Due
- 9/19/2023 9:00:00 AM
- Archive Date
- 09/19/2023
- Point of Contact
- Elena Tatarov
- E-Mail Address
-
elena.tatarov@fda.hhs.gov
(elena.tatarov@fda.hhs.gov)
- Description
- Request for Quotation: FDA-23-1268057 Posted Date: September 14, 2023 Response Date: September 19, 2023, 12:00 p.m Eastern Time. Interested parties may identify in writing their interest and capability to respond by no later than August 21, 2023, 3:00 p.m. Eastern Time. Please email responses to Elena Tatarov at Elena.Tatarov@fda.hhs.gov. Indicate company�s SAM.gov Unique Entity ID on the quote. The subject line shall read: FDA-23-1268057 � ANTI-ANTHRAX TOXIN ANTIBODY, Obiltoxaximab This is a combined synopsis/solicitation for commercial supplies prepared in accordance with the format in FAR 12.6 as supplemented with FAR 8 and additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2023-05. This solicitation is issued as a Request for Quote (RFQ). This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The Government intends to issue a Firm Fixed Price Task Order. NAICS Code: 325414 Line Item Structure: The following is a contract line item number(s), quantities, and units of measure, (including option(s), if applicable): Line Item 0001 - FDA-23-1268057 � ANTI-ANTHRAX TOXIN ANTIBODY, Obiltoxaximab Background Anthrax is a life-threatening disease caused by infection with Bacillus anthracis. The deliberate human use of anthrax has emerged as a biological terrorism threat, highlighted by a series of deadly attacks through the postal service in the form of a finely powdered preparation of anthrax spores in 2001. Anti-anthrax toxin antibodies have been developed as therapeutic for prophylaxis and treatment of inhaled anthrax. Potency control is essential for quality assurance of the anti-anthrax toxin therapeutic antibodies. Our laboratory (the Lab1 of Division of Biotechnology Review and Research II in Office of Biotechnology Products) has been developing a new cell-based potency assay for anti-anthrax toxin therapeutics that reflects the in vivo mechanism of action of the product better than currently available potency assays. This acquisition is for the FDA-approved anti-anthrax toxin antibody, obiltoxaximab, which is a critical reagent for validation of our new cell-based potency assay.�� System Description U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Lab1 of Division of Biotechnology Review and Research II in Office of Biotechnology Products, need a large amount of the anti-anthrax antibody, obiltoxaximab, to validate our cell-based potency assay (10 mg). The antibody must have a high quality to ensure success of validation. The antibody will be provided as solution in a glass vial with a concentration of 10 mg/mL. Requirement The Contractor shall provide antibody that have high purity with extremely low level of endotoxin contamination.PLEASE SEE ATTACHED RFQ.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/0d03ebe7538f41148fbc6c2ea55bb1a6/view)
- Place of Performance
- Address: Silver Spring, MD 20993, USA
- Zip Code: 20993
- Country: USA
- Zip Code: 20993
- Record
- SN06832172-F 20230916/230914230125 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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