SAM #75F40126SSN133276

FDA Sole Source Procurement: Repligen ATF Perfusion System Replacement Components and Services

This notice announces the FDA's intent to award a single source contract to Repligen Corporation for replacement components and accessories for the Alternating Tangential Flow (ATF) Perfusion System and 5L Benchtop Glass Bioreactors. - Agency: U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) - Procurement Type: Single source (sole source) to Repligen Corporation - Purpose: Replacement of critical components and accessories for existing Repligen ATF Perfusion System and 5L Benchtop Glass Bioreactors - Key Products and Services: - XCell Lab Controller (Dual w/ Pressure) - XCell Lab HMI Kit - XCell Flow Sensor Cable Kit - XCell Pressure Cable Kit V2 - XCell Lab Safety Air Protection Assembly - Vacuum System (1 XCell6, 2x4 or 4x2, 115V) - XCell Flow Sensor for ATF 2 - Xcell ATF1/2 Device Clamp On Stand - Fitting, HP, M19, 12mm, PG13.5 entry - Diptube, ATF2, 250mm, 6.6mm ID, 12mm OD - A2B, TC-AQ, ATF2 - Device, ATF2-SU, 0.2u, PES, AQ, Press V2 - Diaphragm for XCell 2 - ATF-2 Hollow Fiber Cartridge, 0.2 UM PES - A2B, TC-TC, SSATF2 - Air Filter, XCell2, A2C line - Pressure Sensor V2 Kit, SS, ATF2 - Tubeset Kit, SSATF2 - Installation for XCLAB - Extended warranty for XCLAB-D - All components must be fully compatible with existing Repligen systems to maintain system integrity and warranties - No alternative vendors or OEMs are considered due to compatibility requirements - Place of performance: FDA facilities in Silver Spring, MD - Contracting office: FDA Office of Acquisition and Grant Services, Rockville, MD

Description

See Attached Single Source Acquisition Notification 75F40126SSN133276

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