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This Pre-Solicitation opportunity from Department Of Health And Human Services was posted on July 29, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

G-Rex500M Bioreactors

Closed
26-008050Federal

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The National Institutes of Health Clinical Center, specifically the Center for Cellular Engineering, intends to award a sole source purchase order to Wilson Wolf Manufacturing for five cases of G-Rex500M-CS bioreactors and associated freight. These bioreactors are essential for FDA-regulated manufacturing processes for cell-based therapies used in NIH clinical trials. Because these specific products have already been validated and approved by the Quality Assurance Department, the government has determined that Wilson Wolf Manufacturing is the only source capable of meeting the requirements without causing costly delays or risking patient care. Although this is not a request for competitive quotations, the government is accepting capability statements from other responsible sources that can provide an equivalent product without requiring additional validation. Interested parties must submit their legal business information, socioeconomic status, and past performance documentation by August 7, 2026, at 11:00 a.m. Eastern Time. The final decision to compete the requirement remains at the discretion of the government, and a sole source award will proceed if no viable alternatives are identified.

General Info

NIH sole source purchase of five G-Rex500M-CS bioreactors from Wilson Wolf Manufacturing.

Contract Value

$38,378.2

NAICS

339113 - Surgical Appliance and Supplies Manufacturing

Place of Performance

Bethesda, MD, 20892, USA

Set-Aside

NONE

Award Issued Date

Documents

0

No documents available

Documents will appear here when they are available.

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Timeline

PhaseClosed
Posted

Presolicitation

Response Deadline

Deadline has passed

Submission Closed

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health Olao
Contacts1 person available
OfficeBETHESDA, MD, 20892, USA
Office AddressBETHESDA, MD, 20892, USA
Contacts

Full Description

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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: contact@example.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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