Fisher Scientific Reagents and Consumable Materials for Cell Therapy Manufacturing
Closed Pre-Solicitation Posted
- Solicitation number
- 26-008155
- 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
- 325413 In-Vitro Diagnostic Substance Manufacturing
- Place of performance
- Bethesda, Maryland 20892, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institutes of Health Clinical Center intends to award a sole-source firm-fixed-price purchase order to Fisher Scientific for validated reagents and consumable materials supporting cell-based therapy manufacturing by August 13, 2026. The Center for Cellular Engineering requires these materials to manufacture FDA-regulated cell therapies for NIH clinical trial patients at the Bethesda, Maryland facility.
All materials have undergone validation within CCE manufacturing processes and received approval from the CCE Quality Assurance Department. Substitution with alternative products would mandate extensive revalidation of manufacturing processes, driving increased costs, schedule delays, and potential impacts to patient care. Fisher Scientific is identified as the only vendor capable of supplying the validated materials and supporting documentation necessary for FDA-regulated manufacturing. The sole-source rationale rests on the validated nature of the current materials, the prohibitive costs and timeline risks of requalifying alternatives, and the direct relationship between product continuity and patient care outcomes in active clinical trials.
Notice text
NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT
Title: Fisher Scientific Reagents and Consumable Materials for Cell Therapy Manufacturing
Notice ID (POTS): 26-008155
Product Service Code (PSC): 6550 – In Vitro Diagnostic Substances, Reagents, Test Kits, and Sets
NAICS Code: 325413 – In-Vitro Diagnostic Substance Manufacturing
Place of Performance: National Institutes of Health
Clinical Center
Bethesda, MD 20892
Notice
The National Institutes of Health (NIH) Clinical Center intends to award a sole-source firm-fixed-price purchase order to Fisher Scientific for validated reagents and consumable materials required by the Center for Cellular Engineering (CCE) to manufacture FDA-regulated cell-based therapies for use in NIH clinical trials.
Requirement
The Center for Cellular Engineering (CCE) uses these reagents and consumable materials in the manufacture of FDA-regulated cell-based therapies for patients enrolled in clinical trials at the NIH Clinical Center. All materials have been validated for use in CCE manufacturing processes to ensure they consistently meet the quality standards required to produce safe and effective cell therapy products. Additionally, each material has been reviewed and approved by the CCE Quality Assurance Department, and substitution with alternative products would require extensive revalidation of manufacturing processes, resulting in increased costs, schedule delays, and potential impacts to patient care.
Sole-Source Rationale
The required reagents and consumables have been validated and approved for use in CCE manufacturing processes. Substituting alternate materials would require extensive requalification, increase costs, delay production, and negatively affect patient care. Fisher Scientific is the only vendor capable of providing the required validated materials and supporting documentation necessary for FDA-regulated manufacturing.
Authority
The intended sole-source acquisition is authorized under Federal Acquisition Regulation (FAR) 13.106-1(b)(1)(i), which permits solicitation from a single source when the Contracting Officer determines that only one source is reasonably available for an acquisition not exceeding the Simplified Acquisition Threshold.
Capability Statements
This notice is not a request for quotations or proposals. However, responsible sources that believe they can satisfy the Government's requirement may submit a written capability statement. The Government will evaluate all capability statements received; however, the determination not to compete this requirement remains solely within the Government's discretion.
Submission Instructions
Capability statements shall reference POTS 26-008155 and must be submitted electronically no later than August 13, 2026, at 6:00 P.M. Eastern Time (ET).
Point of Contact
Shasheshe Goolsby
Team Leader
Hospital and Laboratory Support Division
Office of Acquisitions and Logistics Management
National Institutes of Health
Email: shasheshe.goolsby@nih.gov
Similar open opportunities
On GovTribe
Work this opportunity
- Track it in your pipeline
- Find teaming partners
- Similar opportunities
- Ask GovTribe AI about this opportunity