SAM #26-008155

Sole Source Procurement of Fisher Scientific Reagents and Consumable Materials for Cell Therapy Manufacturing at NIH Clinical Center

This opportunity involves a sole-source procurement for the NIH Clinical Center's Center for Cellular Engineering (CCE) to support cell therapy manufacturing for clinical trials. - Government Buyer: - National Institutes of Health (NIH) Clinical Center, Department of Health and Human Services - Center for Cellular Engineering (CCE) - OEMs and Vendors: - Fisher Scientific (highlighted as sole-source provider) - Products/Services Requested: - Validated reagents and consumable materials for cell-based therapy manufacturing - Materials must be approved by CCE Quality Assurance for FDA-regulated processes - No specific part numbers or quantities provided - Unique/Notable Requirements: - Sole-source justification: Only Fisher Scientific can provide the validated materials and supporting documentation required for FDA compliance - Substituting alternative products would require extensive revalidation, increase costs, cause schedule delays, and potentially impact patient care - All materials must meet strict quality assurance and regulatory standards for clinical manufacturing

Description

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

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