Repligen Corporation Alternating Tangential Flow (ATF) Perfusion System with 5L Benchtop Glass Bioreactors replacement Controllers and Accessories.

The U.S. Food and Drug Administration’s Office of Acquisition and Grants Services, under the Department of Health and Human Services, intends to award a single-source purchase order to Repligen Corporation for the replacement of controllers and associated accessories for an Alternating Tangential Flow (ATF) Perfusion System used with 5L Benchtop Glass Bioreactors at its Silver Spring, Maryland facility. This procurement is justified under FAR 6.103-1, as Repligen is the sole source of components compatible with the existing system, and no alternative supplier can meet the required technical specifications without compromising system integrity, performance, or valid warranties. The required components include the XCell Lab Controller, Dual w/ Pressure HMI Kit, Flow Sensor Cable and Pressure Cable Kit V2, Safety Air Protection Assembly, Vacuum System, ATF2 Hollow Fiber Cartridge, Diaphragm, Fittings, Diptubes, Tubeset Kit, Pressure Sensor Kit, and related installation and warranty services—all must be original Repligen-manufactured parts to ensure operational continuity and compliance with existing service agreements. The procurement is not open for competitive bidding but serves as a notice of intent to award, with interested parties permitted to submit a capability statement by May 27, 2026, at 1:00 PM Central Time to the designated point of contact, Howard Nesmith. All deliverables must be delivered to Silver Spring, Maryland, and must demonstrate 100% compatibility with the current ATF system infrastructure. The NAICS code associated with this acquisition is 334516, and while the contract value, delivery schedule, and pricing details are not provided, the requirement explicitly prohibits substitution of non-Repligen components, which would void warranties and disrupt critical regulatory science activities in continuous biomanufacturing of protein therapeutics. No formal contract clauses, evaluation factors, or inspection criteria are included in this notice, as it functions solely as an advance notification prior to the issuance of a sole-source purchase order.