G-Rex500M Bioreactors
Closed Pre-Solicitation Posted
- Solicitation number
- 26-008050
- 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, Center for Cellular Engineering intends to award a sole-source purchase order to Wilson Wolf Manufacturing for five cases of GRex500M-CS bioreactors and associated freight by August 7, 2026.
The procurement is justified under FAR 13.106-1(b)(1) (Only One Source Reasonably Available) and is not set aside. The CCE uses these bioreactors in FDA-regulated manufacturing processes for cell-based therapies supporting NIH clinical trials. The equipment has been validated and approved by the CCE Quality Assurance Department. Wilson Wolf Manufacturing is identified as the only known source capable of providing validated GRex500M bioreactors meeting Government requirements; substituting another manufacturer's product would require extensive qualification and validation testing, increase costs, delay manufacturing schedules, and risk adverse impact to timely treatment of critically ill patients.
Although this is not a competitive solicitation, the notice invites any responsible source believing it can provide an equivalent product meeting all technical and quality requirements to submit a capability statement with supporting documentation demonstrating ability to satisfy the requirement without additional validation or interruption to patient care. Capability statements must include legal business name, address, Unique Entity ID, CAGE code, and point-of-contact information; business size under NAICS 339113 and applicable socioeconomic status; and relevant past performance information for comparable requirements.
Notice text
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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