G-Rex500M Bioreactors for Cell Therapy Manufacturing
Closed Pre-Solicitation Posted
- Solicitation number
- 26-005780
- Agency
-
Office of Logisitics and Acquisition Operations
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 339113 Surgical Appliance and Supplies Manufacturing
- Place of performance
- Bethesda, Maryland 20892, United States
- Points of contact
-
- Shasheshe Goolsby shasheshe.goolsby@nih.gov (301) 827-4879
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institutes of Health Clinical Center intends to award a sole-source, firm-fixed-price purchase order to Wilson Wolf Manufacturing LLC for seven cases of GRex500M-CS bioreactors, with a response deadline of July 17, 2026. This is a Notice of Intent only and does not constitute a competitive solicitation.
Place of performance is the NIH Clinical Center in Bethesda, Maryland. The Center for Cellular Engineering uses validated GRex500M bioreactors in FDA-regulated manufacturing processes for cell-based therapies supporting patients enrolled in NIH clinical trials. Continued use of these validated bioreactors is essential to maintain manufacturing consistency, comply with approved production protocols, and ensure uninterrupted patient care.
Wilson Wolf Manufacturing LLC, located in Saint Paul, Minnesota, is identified as the sole known source capable of providing the validated GRex500M bioreactors. The rationale for sole-source award rests on the fact that substituting another product would require extensive process validation and qualification, resulting in increased costs, schedule delays, and potential interruptions to cell-based therapy manufacturing that could adversely affect treatment schedules for critically ill patients. The acquisition is conducted under FAR 13.106-1(b)(1).
Notice text
NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT
Title: G-Rex500M Bioreactors for Cell Therapy Manufacturing
Notice ID (POTS): 26-005780
Product Service Code (PSC): 6515 – Medical and Surgical Instruments, Equipment, and Supplies
NAICS Code: 339113 – Surgical Appliance and Supplies Manufacturing
Place of Performance: National Institutes of Health
Clinical Center
Bethesda, MD 20892
Description
This Notice of Intent (NOI) is issued for informational purposes only and does not constitute a Request for Quotations (RFQ). The Government does not intend to solicit competitive quotations for this requirement.
The National Institutes of Health (NIH), Clinical Center, Office of Acquisitions and Logistics Management (OALM), intends to award a sole-source, firm-fixed-price purchase order to Wilson Wolf Manufacturing LLC, 2100 Old Highway 8 NW, Saint Paul, Minnesota 55112-1802, for seven (7) cases of G‑Rex500M-CS bioreactors to support the manufacture of cell-based therapies for patients enrolled in NIH clinical trials.
Required Items
Product: G‑Rex500M-CS (2-Pack Box)
Product Code: G285500-CS
Quantity: 7 Cases
Background
The Center for Cellular Engineering (CCE) uses validated G‑Rex500M bioreactors in FDA-regulated manufacturing processes for the production of cell-based therapies. Continued use of these validated bioreactors is essential to maintain manufacturing consistency, comply with approved production protocols, and ensure uninterrupted patient care.
Sole Source Rationale
Wilson Wolf Manufacturing LLC is the only known source capable of providing the validated G‑Rex500M bioreactors required by the Government. Substituting another product would require extensive process validation and qualification, resulting in increased costs, schedule delays, and potential interruptions to the manufacture of cell-based therapies, which could adversely affect treatment schedules for critically ill patients.
Authority
This acquisition is being conducted pursuant to FAR 13.106-1(b)(1), Soliciting from a Single Source. Under this authority, the Contracting Officer may solicit from one source when only one source is reasonably available. Acquisitions under FAR Part 13 are exempt from the competition requirements of FAR Part 6.
Responses
This is not a Request for Quotations. Interested parties believing they can satisfy this requirement may submit a capability statement that includes:
• Company name and address
• Technical capability
• Proof of OEM authorization, if applicable
• Relevant past performance
The Government will evaluate all capability statements received; however, the decision not to compete this requirement remains solely within the Government's discretion.
Submission Instructions
Capability statements shall reference POTS 26-005780 and must be submitted electronically no later than July 17, 2026, at 11:00 a.m. Eastern Time (ET).
Shasheshe Goolsby
Team Leader
Hospital and Laboratory Support Division
Office of Acquisitions and Logistics Management
National Institutes of Health
Email: shasheshe.goolsby@nih.gov
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