G-Rex500M Bioreactors for Cell Therapy Manufacturing
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
AI Contract Overview
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 G‑Rex500M-CS bioreactors to support the manufacturing of cell-based therapies for patients in NIH clinical trials. These bioreactors are critical to maintaining validated, FDA-regulated manufacturing processes, and substituting them with alternative equipment would necessitate extensive revalidation, leading to costly delays and disruptions in patient care. The requirement is justified under FAR 13.106-1(b)(1) due to Wilson Wolf being the sole source capable of supplying the specifically validated G‑Rex500M-CS units, which are integral to established production protocols. The purchase will be executed under the Product Service Code 6515 and NAICS Code 339113, with performance occurring at the NIH Clinical Center in Bethesda, Maryland. This notice is not a solicitation and does not obligate the government to award a contract; however, interested parties may submit capability statements by July 17, 2026, at 11:00 a.m. Eastern Time, to demonstrate their ability to meet the requirement. Submissions must include company information, technical capability, proof of OEM authorization if applicable, and past performance details, and must reference POTS 26-005780. While all submissions will be reviewed, the government retains full discretion to proceed with the sole-source award to Wilson Wolf Manufacturing LLC without competitive bidding, as no alternative vendor can provide the identical validated product without disrupting ongoing clinical therapies. All communications and submissions should be directed to Shasheshe Goolsby at the Office of Acquisitions and Logistics Management.
General Info
Agency
NAICS
Place of Performance
Bethesda, MD, 20892, USASet-Aside
Documents
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Organization & Contact Information
Full Description
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