SAM #26-008050

NIH Sole Source Procurement of G-Rex500M-CS Bioreactors for Cell Therapy Manufacturing

NIH's Clinical Center, Center for Cellular Engineering (CCE) is seeking to procure specialized bioreactors for cell-based therapy manufacturing. - Government Buyer: - Department of Health and Human Services (HHS) - National Institutes of Health (NIH) - Clinical Center, Center for Cellular Engineering (CCE) - OEM Highlight: - Wilson Wolf Manufacturing is the sole OEM mentioned and validated for this requirement - Products Requested: - G-Rex500M-CS Bioreactor (2-pack box) - Total quantity: 5 cases (each case contains 2 bioreactors) - Includes associated freight - Validated for FDA-regulated cell-based therapy manufacturing - Unique Requirements: - Only Wilson Wolf Manufacturing's bioreactors are approved by CCE's Quality Assurance Department - Substituting another manufacturer's product would require extensive qualification and validation - Opportunity for other vendors to submit capability statements if they can meet all technical and quality requirements without additional validation - Notable Details: - The bioreactors are critical for patient care and FDA compliance - Sole source procurement is justified by technical and quality validation

Description

Agency: Department of Health and Human Services (HHS), National Institutes of Health (NIH), Clinical Center

Office: Center for Cellular Engineering (CCE)

Title: G-Rex500M Bioreactors

NAICS Code: 339113 – Surgical Appliance and Supplies Manufacturing

PSC Code: 6530 – Hospital Furniture, Equipment, Utensils, and Supplies

Authority: FAR 13.106-1(b)(1), Only One Source Reasonably Available (Simplified Acquisition Threshold)

Description

The National Institutes of Health (NIH), Clinical Center, Center for Cellular Engineering (CCE) intends to award a sole source purchase order to Wilson Wolf Manufacturing for the acquisition of five (5) cases of G‑Rex500M-CS (2-pack box) bioreactors and associated freight.

Justification

CCE uses G‑Rex500M bioreactors in validated FDA-regulated manufacturing processes for cell-based therapies supporting NIH clinical trials. These bioreactors have been validated and approved by the CCE Quality Assurance Department. Substituting another manufacturer's product would require extensive qualification and validation testing, increase costs, delay manufacturing schedules, and could adversely impact the timely treatment of critically ill patients. Wilson Wolf Manufacturing is the only known source capable of providing the validated G‑Rex500M bioreactors that meet the Government's requirements.

Interested Sources

This is not a request for competitive quotations. However, any responsible source that believes it can provide an equivalent product meeting all of the Government's technical and quality requirements may submit a capability statement with supporting documentation demonstrating its ability to satisfy the requirement without additional validation or interruption to patient care.

Capability statements should include:

Legal business name, address, Unique Entity ID, CAGE code, and point-of-contact information.

Business size under NAICS 339113 and applicable socioeconomic status.

Relevant past performance information for comparable requirements.

Responses must reference Notice ID 26-008050 and be submitted electronically no later than August 7, 2026, at 11:00 a.m. Eastern Time. Telephone inquiries will not be accepted.:

Shasheshe Goolsby Team Leader Hospital and Laboratory Support Division Office of Acquisitions and Logistics Management National Institutes of Health Email: shasheshe.goolsby@nih.gov

The Government will evaluate all capability statements received. However, the determination not to compete this requirement remains solely within the Government's discretion.

Disclaimer

If no affirmative written responses are received by the closing date, the Government intends to proceed with a sole source award to Wilson Wolf Manufacturing.

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