ANTI-ANTHRAX TOXIN ANTIBODY, RAXIBACUMAB

Request for Quotation : FDA-23-1268046 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 September 19, 12:00 p.m. Eastern Time. Please email responses to Elena Tatarov at [email protected]. Indicate company’s SAM.gov Unique Entity ID on the quote. The subject line shall read: FDA-23-1268046 – ANTI-ANTHRAX TOXIN ANTIBODY, RAXIBACUMAB 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-23-1268046 – ANTI-ANTHRAX TOXIN ANTIBODY, RAXIBACUMAB 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 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, raxibacumab, 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, raxibacumab, to validate our cell-based potency assay (10 mg). The antibody shall be 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. Deliverables The Contractor shall provide antibody to be delivered as solution in a single glass vial at the concentration of 10 mg/mL. PLEASE SEE ATTACHED RFQ FOR ALL DETAILS.