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CryoStor® CS10, 100 mL Bags for Cell Therapy Manufacturing

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Federal

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 intends to award a sole-source, firm-fixed-price purchase order to BioLife Solutions for 80 units of CryoStor CS10 100 mL bags. These materials are essential for the Center for Cellular Engineering to cryopreserve FDA-regulated cell therapy products used in clinical trials. The procurement is categorized under NAICS code 325413 and PSC 6550, with the place of performance located in Bethesda, Maryland. The justification for the sole-source award is based on the fact that CryoStor CS10 is the only commercial cryoprotectant with an FDA Master File and has already been validated for the specific manufacturing protocols used by the CCE. Substituting an alternative product would lead to significant costs, schedule delays, and potential risks to patient care due to the need for extensive revalidation. This action is authorized under FAR 13.106-1(b)(1)(i). While this is a notice of intent for a sole-source award, interested parties may submit capability statements by August 13, 2026.

General Info

NIH sole-source award to BioLife Solutions for 80 CryoStor CS10 cryopreservation bags.

Agency

Department Of Health And Human Services → National Institutes Of Health Olao

NAICS

325413 - In-Vitro Diagnostic Substance Manufacturing

Place of Performance

MD, 20892, USA

Set-Aside

NONE

Documents

No documents available

Documents will appear here when they are available.

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Uniform Contract Format

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Timeline

PostedMar 18

pre-forecast

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Organization & Contact Information

AgencyDepartment Of Health And Human Services → National Institutes Of Health Olao

Contacts1 person available

OfficeBETHESDA, MD, 20892, USA

Organization / AgencyDepartment Of Health And Human Services → National Institutes Of Health Olao

Office AddressBETHESDA, MD, 20892, USA

Contacts

Shasheshe Goolsby

contact@example.gov

+1 (555) 000-0000

Full Description

Predicted recompete opportunity based on federal award data.
Current Contract: 75N98026P01363 Incumbent: BIOLIFE SOLUTIONS, INC. Contract Value: $44,738.36 Potential End Date: 2026-09-18T00:00:00.000Z Competition: COMPETED UNDER SAP Pricing: FIRM FIXED PRICE Classification: recompete-likely (Confidence: medium - 55/100)

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: contact@example.gov