CryoStor® CS10, 100 mL Bags for Cell Therapy Manufacturing
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
AI Contract Overview
The National Institutes of Health Clinical Center plans to award a sole-source firm-fixed-price purchase order to BioLife Solutions for 80 bags of CryoStor® CS10, 100 mL, used exclusively for cryopreserving cell therapy products in FDA-regulated clinical trials. The product is essential to the Center for Cellular Engineering’s manufacturing processes, having been rigorously validated and approved by quality assurance to ensure the safety and consistency of therapies administered to patients. Substituting an alternative cryoprotectant would necessitate extensive revalidation, leading to significant delays, increased costs, and potential disruption to patient care. CryoStor® CS10 is the only commercial cryoprotectant with an FDA Master File and is the only product fully qualified for use in the NIH’s regulated environment, justifying the sole-source designation under FAR 13.106-1(b)(1)(i). The acquisition supports critical clinical research operations at the NIH Clinical Center in Bethesda, Maryland, under PSC 6550 and NAICS 325413. While the notice does not request formal proposals, responsible parties may submit capability statements by August 13, 2026, though the government reserves the right to proceed without competition. All submissions must reference solicitation number 26-007655 and be sent electronically to Shasheshe Goolsby at the NIH Office of Acquisitions and Logistics Management.
General Info
Agency
NAICS
Place of Performance
MD, 20892, USASet-Aside
Documents
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Full 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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