Replacement Controllers and Accessories for ATF Perfusion System

The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), intends to award a sole source purchase order to Repligen Corporation for replacement controllers and accessories for their Alternating Tangential Flow (ATF) Perfusion System and 5L Benchtop Glass Bioreactors. These components are critical for maintaining the operational capability and compatibility of the existing research and development equipment, which supports essential regulatory science activities in continuous biomanufacturing of protein therapeutics. The required components include the XCellLab Controller-Dual w/ Pressure, XCellLab HMI Kit, XCellFlow Sensor Cable Kit, XCell Pressure Cable Kit V2, XCellLab Safety Air Protection Assembly, Vacuum System, XCellFlow Sensor for ATF2, Xcell ATF1/2 Device Clamp On Stand, various fittings and diptubes, installation services, extended warranty, and specific devices and cartridges like the ATF-2 Hollow Fiber Cartridge. The replacement components must be 100% compatible with the existing system to maintain integrity and performance standards, and to avoid violating current warranties or service agreements. No other sources have been identified as capable of providing these compatible components.