Repligen Corporation Alternating Tangential Flow (ATF) Perfusion System with 5L Benchtop Glass Bioreactors replacement Controllers and Accessories.
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), intends to award a single-source purchase order to Repligen Corporation for replacement controllers and accessories for the Alternating Tangential Flow (ATF) Perfusion System with 5L Benchtop Glass Bioreactors. This acquisition is critical for ongoing research and development activities in continuous biomanufacturing of protein therapeutics, ensuring continued operational capability and compatibility with existing infrastructure. Firms believing they can provide the required items may submit a capability statement by May 27, 2026, 1:00 PM Central Time.
Scope of Requirements
The requirement includes specific Repligen Corporation components, such as:
- 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
- Various fittings, diptubes, devices, diaphragms, cartridges, and tubeset kits.
- Installation services for XCLAB and extended warranty.
Contract Details
- Type: Purchase Order (Single-Source Intent)
- Statutory Authority: FAR RFO 6.103-1
- NAICS Code: 325414 - Biological Product (except Diagnostic) Manufacturing
- Small Business Size Standard: 1,250 employees
- Place of Performance: Silver Spring, MD
Submission & Evaluation
This is a notice of intent to award a sole-source contract and is NOT a request for competitive proposals. However, firms that believe they can provide the required items and installation, which must be 100% compatible with the existing ATF Perfusion System, may submit a capability statement. The determination to compete this procurement based on responses is at the Government's discretion.
- Capability Statements Due: May 27, 2026, 1:00 PM Central Time
- Submission Email: howard.nesmith@fda.hhs.gov
Additional Notes
The sole-source determination is based on the critical need for 100% compatibility with the existing system to maintain integrity, ensure reliable installation, prevent operational interruptions, and avoid violating current warranties/service agreements. No other sources have been identified as capable of providing these specific, compatible components.