SAM #26-005780

NIH Sole Source Procurement: Wilson Wolf G-Rex500M-CS Bioreactors for Cell Therapy

The National Institutes of Health (NIH) Clinical Center, Office of Acquisitions and Logistics Management (OALM), is planning a sole-source procurement for specialized bioreactors to support cell therapy manufacturing: - Government Buyer: - National Institutes of Health (NIH) - Clinical Center, Office of Acquisitions and Logistics Management (OALM) - OEM Highlight: - Wilson Wolf Manufacturing LLC is the sole OEM and vendor for the required bioreactors - Products/Quantities: - Seven (7) cases of G-Rex500M-CS bioreactors (2-Pack Box) - Product code: G285500-CS - Purpose and Requirements: - Bioreactors are essential for manufacturing cell therapies for patients in NIH clinical trials - Required to maintain manufacturing consistency and compliance with FDA-regulated protocols - Only Wilson Wolf's validated G-Rex500M bioreactors are acceptable; substitutes would require extensive revalidation and could disrupt patient care - No other OEMs or vendors are mentioned as capable sources

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

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