CryoStor® CS10, 100 mL Bags for Cell Therapy Manufacturing

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