Inactive

Miltenyi CliniMACS Reagents Product Service Code: 6550-In Vitro Diagnostic Substances, Reagents, Test Kits and Sets NAICS Code: 325413-In Vitro Diagnostic Substance Manufacturing (Small Business Size ... Miltenyi CliniMACS Reagents Product Service Code: 6550-In Vitro Diagnostic Substances, Reagents, Test Kits and Sets NAICS Code: 325413-In Vitro Diagnostic Substance Manufacturing (Small Business Size Standards Average Number of Employees 1,250) Place of Performance: National Institutes of Health Clinical Center 10 Center Drive Building 10, Room TBD Bethesda, MD 20892 POTS: 24-003968 Description: This is a notice of intent, not a request for a quotation. A solicitation document will not be issued, and quotations will not be requested. The National Institutes of Health (NIH), Office of Purchasing and Contracts on behalf of the Center for Cellular Engineering intends to award a fixed price contract for a one-time purchase on a sole source basis to Miltenyi Biotec, Inc. for the supply of CliniMACS Reagents. Proposed Contractor: Miltenyi Biotec, Inc. 2303 Lindberg Street Auburn, CA 95602-9562 Line Item 1-CliniMACS CD14 Reagent CR/GMP-200-070-121 Quantity 3 Vials Line Item 2-CliniMACS CD62L Reagent CR/GMP- Product Number: 200-070-236 Quantiy 4 Vials Miltenyi Biotec is the original manufacturer and the only supplier in the United States. Miltenyi Biotec is the only company with Good Manufacturing Practice (GMP)-grade CD14 and CD62L CliniMACS beads that can be used with 21 CFR Part 11 that is compliant and compatible with the Miltenyi CliniMACS Plus and CliniMACS Prodigy systems. The CD14 and CD62L beads will be used to de-enrich monocytes (CD14) and subsequently enrich naïve T cells (CD62L) prior to manufacture of an engineered T-cell therapy against mesothelin, a common target for epithelial cancers. The Center for Cellular Engineering (CCE) uses Miltenyi reagents used to manufacture cell-based therapies for patients. All materials have been validated in manufacturing process to ensure the appropriate quality to produce the quality for the desired results. In addition, all materials are approved by the Center for Cellular Engineering Quality Assurance Department and there are no substitutions. This acquisition is being conducted using policies unique to the Federal Acquisition Regulation (FAR) Part 13 – Simplified Acquisition Procedures, Subpart 13.106-1(b)(1), For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. Interested parties may identify their interest and capabilities in response to this posting. The determination by the Government not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government. Comments to this announcement, referencing this posting number in the email subject line, may be submitted to the CC, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Sheri Eiri, Contract Specialist, sheri.eiri.nih.gov by the due date February 5, 2024, 12:00 pm EST Local Time and time marked in this notice.