SAM #26-007655

Sole-source procurement of BioLife Solutions CryoStor CS10 bags for NIH cell therapy manufacturing

This opportunity involves a sole-source procurement by the National Institutes of Health (NIH) Clinical Center for specialized cryopreservation bags used in cell therapy manufacturing. - Government Buyer: - Department of Health and Human Services - National Institutes of Health (NIH) Clinical Center - Center for Cellular Engineering (CCE) - OEMs and Vendors: - BioLife Solutions (OEM) - Products Requested: - CryoStor® CS10, 100 mL bags - Catalog number: 210202 - Quantity: 80 - Unique/Notable Requirements: - CryoStor CS10 is uniquely validated for CCE manufacturing protocols and has an FDA Master File - Substituting another cryoprotectant would require extensive revalidation and could impact patient care - Product is approved by the CCE Quality Assurance Department and is critical for maintaining quality standards in cell therapy manufacturing - Sole-source procurement authorized under FAR 13.106-1(b)(1)(i) for acquisitions below the Simplified Acquisition Threshold - No other OEMs or vendors are referenced; BioLife Solutions is the only manufacturer mentioned

Description

NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT

Title: CryoStor® CS10, 100 mL Bags for Cell Therapy Manufacturing Notice ID (POTS): 26-007655 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 BioLife Solutions for CryoStor® CS10, 100 mL bags required by the Center for Cellular Engineering (CCE) for the cryopreservation of FDA-regulated cell therapy products used in NIH clinical trials.

Requirement

The Center for Cellular Engineering (CCE) uses CryoStor® CS10 to cryopreserve cell-based therapies for patients enrolled in clinical trials at the NIH Clinical Center. The material has been validated for use in CCE manufacturing processes to ensure it consistently meets the quality standards required to produce safe and effective cell therapy products. The reagent has also been approved by the CCE Quality Assurance Department. Substituting an alternate cryoprotectant would require extensive revalidation of manufacturing processes, resulting in increased costs, schedule delays, and potential impacts to patient care.

The following items are required for this action:

Catalog Number/Description/Quantity

210202/CryoStor CS10 - 100mL Bag/80 Bags

Sole-Source Rationale

CryoStor® CS10 is the only commercial cryoprotectant with an FDA Master File and has been validated for CCE manufacturing protocols. BioLife Solutions is the manufacturer of the validated product used in CCE's FDA-regulated processes. Substituting another cryoprotectant would require extensive testing and requalification, delaying patient treatment and increasing costs.

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. 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 26-007655 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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