SSN 75F40126Q133276.pdf

Single Source Acquisition Notification

75F40126SSN133276

The U.S. Food and Drug Administration (FDA), Office of Acquisition and Grants Services (OAGS), for the Center for Drug Evaluation and Research (CDER), intends to award a Purchase Order on a Single Source basis to Repligen Corporation, 41 Seyon ST STE 100 Bldg 1, Waltham, Massachusetts 02453, under the authority of FAR RFO 6.103-1, Only one Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

The FDA/CDER currently operates an Alternating Tangential Flow (ATF) Perfusion System manufactured by Repligen Corporation in conjunction with 5L Benchtop Glass Bioreactors for critical research and development activities. The existing controllers for the ATF Perfusion System require replacement to ensure continued operational capability and compatibility with the current equipment infrastructure. The System supports essential regulatory science activities in continuous biomanufacturing of protein therapeutics.

The associated North American Industry Classification System (NAICS) Code 325414 - Biological Product (except Diagnostic) Manufacturing; with a Small Business Size standard in number of employees, 1,250.

This notice is being published in accordance with FAR RFO 6.103-1 Only one Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements requiring the dissemination of information on proposed contract actions. This is a notice of intent to award an only one source contract and is not a request for competitive proposals. The statutory authority for this only one source procurement is FAR RFO 6.103-1.

Any firm that believes they can provide the required items and installation as stated herein may submit their capability statement referencing Solicitation 75F40126SSN133276 to document their ability on or before May 27, 2026 by 1:00 PM Central Time - Local Prevailing Time in Jefferson, Arkansas by e-Mail to howard.nesmith@fda.hhs.gov. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government.

Required Repligen Corporation Components:

• 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 Sys, 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

• Installation for XCLAB

• Com SP / Ext Warranty for XCLAB-D mailto:howard.nesmith@fda.hhs.gov

• 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

Single Source Determination Based Upon:

• The replacement components must be 100% compatible with existing ATF Perfusion System and 5L Benchtop Glass Bioreactors currently in use at the facility.

• Maintain system integrity and performance standards by utilizing components specifically designed for compatibility with existing equipment.

• Assurance of reliable installation and uninterrupted operations by obtaining ancillary components of the current System manufacturer.

• The introduction of non-Repligen Corporation approved/manufactured components will violate current warranties/service agreements.

• No additional sources have been identified as being capable of providing 100% compatible components for the existing System.