Notice of Intent - 75N98026Q01245.pdf

NOTICE OF INTENT – SOLE SOURCE

ACQUISITION

Notice No.: 75N98026Q01245

Sole Source Justification and Notice Authority

FAR 6.302-1 — Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

Contracting Activity:

National Cancer Institute (NCI) National Institutes of Health (NIH)

Proposed Contractor:

Miltenyi Biotec

Description of Requirement

The National Cancer Institute (NCI), National Institutes of Health (NIH), intends to award a purchase order to Miltenyi Biotec for a gentleMACS™ Dissociator with Heaters (G3) platform and associated proprietary components, consumables, and accessories.

The requested gentleMACS™ Dissociator with Heaters (G3) platform is required because it provides an integrated system for automated tissue dissociation, homogenization, and perfusion in a closed and standardized format. The Government's minimum requirements include the ability to perform these functions within an integrated platform while maintaining compatibility with proprietary processing tubes, perfusion components, temperature-control accessories, and automated protocols.

Only One Responsible Source: Miltenyi Biotec

Required System Capabilities

The gentleMACS™ Dissociator with Heaters (G3) system provides the following capabilities required by the Government:

• Automated generation of single-cell and single-nucleus suspensions using proprietary gentleMACS C Tubes;

• Automated tissue homogenization using gentleMACS M Tubes;

• Automated tissue perfusion workflows using gentleMACS Perfusion Technology, including compatible perfusers with integrated peristaltic pump systems and needle arrays;

• Closed-system processing designed to minimize contamination risk and provide reproducible processing across samples;

• Defined and standardized processing protocols incorporated into the instrument platform;

• Processing capacity for up to eight samples using the Octo configuration;

• Integrated heating functionality for controlled tissue-dissociation workflows;

• Compatibility with cooling modules, including the gentleMACS Octo Cooler, for cold-processing applications such as sensitive nuclei-extraction workflows; and

• Specialized rotor/stator tube technology designed specifically for controlled and efficient mechanical tissue dissociation.

The required capabilities are functionally interdependent and cannot be replicated by simply combining unrelated devices without changing the Government's required workflow, processing conditions, and system configuration.

Integrated Hardware and Consumables Ecosystem

The gentleMACS™ system operates as an integrated hardware-and-consumables ecosystem consisting of the instrument, proprietary processing tubes, perfusion devices, cooling accessories, and related components. These components are specifically designed to function together.

The Government requires compatibility with the following proprietary components, as applicable:

• gentleMACS™ Perfusers and Perfusers 2;

• gentleMACS™ C Tubes;

• gentleMACS™ M Tubes;

• gentleMACS™ Octo Cooler; and

• other manufacturer-specific accessories and consumables required for the intended workflows.

The design and performance characteristics of these components are dependent upon their compatibility with the gentleMACS™ instrument platform. Substituting individual components with products from other manufacturers would not reproduce the required integrated processing conditions, automation, temperature control, workflow, and reproducibility.

Advanced Perfusion and Custom Processing Requirements

The Government requires the ability to perform automated tissue perfusion in conjunction with tissue dissociation and other sample-processing workflows.

Earlier versions of the gentleMACS™ instrument, including the gentleMACS Octo without Heaters, the gentleMACS Octo with Heaters (G2), and earlier gentleMACS™ configurations, do not provide the complete combination of capabilities required by the Government.

The required G3 configuration provides the combination of:

• tissue perfusion functionality;

• integrated heating;

• compatibility with cooling accessories;

• digital interface and workflow control;

• expanded custom protocol functionality; and

• automated processing capabilities for complex tissue applications.

These capabilities are required to support workflows involving liver and heart perfusion, custom organoid and complex-tissue dissociation, and other customized tissue-processing applications.

The Government has determined that the required combination of perfusion, dissociation, homogenization, temperature control, automated processing, and custom protocol functionality is not available through the Government's existing equipment or through the combination of separate commercially available devices without substantial changes to the required workflow.

Proprietary Components and Source Availability

Miltenyi Biotec is the manufacturer and source of the gentleMACS™ Dissociator platform and the associated proprietary consumables, perfusion components, accessories, and system configurations required to meet the Government's specifications.

The gentleMACS™ Perfusion Technology is designed for use with the compatible gentleMACS™ Octo Dissociator with Heaters platform. The perfusion components, processing tubes, cooling accessories, and instrument controls are designed as an integrated system and are not interchangeable with equivalent components from other manufacturers.

The Government's requirement is not based solely on the brand name of the equipment.

Rather, the requirement is based on the specific technical capabilities and integrated system characteristics necessary to meet the Government's minimum research requirements.

Basis for Sole-Source Determination

The Government requires a single integrated platform capable of performing automated tissue dissociation, homogenization, and perfusion while providing:

1. Closed-system processing;

2. Automated and standardized protocols;

3. Integrated heating;

4. Compatibility with controlled cooling;

5. Automated processing of multiple samples;

6. Digital and customized protocol capabilities;

7. Compatibility with proprietary processing tubes and perfusion components; and

8. An integrated hardware-and-consumables ecosystem designed and validated to operate together.

No alternative product or combination of products identified by the Government provides the required combination of capabilities within a single integrated platform while maintaining compatibility with the required proprietary consumables and perfusion components.

Using separate instruments or equipment from multiple manufacturers would require additional equipment, system integration, method development, and validation and would alter the Government's required processing workflow and operating conditions.

Miltenyi Biotec provides manufacturer-specific technical support and validated system configurations for the gentleMACS™ platform. Because the required instrument, consumables, perfusion components, and accessories are proprietary and functionally interdependent, Miltenyi Biotec is the only responsible source currently identified by the Government as capable of providing the required system and associated components that satisfy the Government's technical requirements.

Accordingly, pursuant to FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements, the Government intends to solicit and negotiate with Miltenyi Biotec on a sole-source basis.

The Government will consider any capability statement received from an interested source that demonstrates the ability to satisfy all of the stated technical requirements.

Notice

This notice is not a request for competitive quotations or proposals. However, interested parties, including small businesses, may submit a written capability statement demonstrating their ability to provide the required system and satisfy the Government's technical requirements.

Capability statements must provide sufficient technical information to demonstrate the firm's ability to meet all of the requirements described in this notice. Responses should specifically address the firm's ability to provide:

• Automated tissue dissociation and homogenization;

• Automated tissue perfusion;

• Closed-system processing;

• Integrated heating and compatible cooling capabilities;

• Automated multi-sample processing;

• Digital and customized protocol functionality;

• Compatibility with the required processing tubes and perfusion components; and

• An integrated system capable of supporting the Government's specified research workflows.

General statements of capability or descriptions of products that do not specifically address the Government's stated technical requirements will not be considered sufficient.

Submission of a capability statement does not constitute a commitment by the Government to compete the proposed acquisition. Any determination to compete the requirement will be made solely at the discretion of the Government.

An award is anticipated approximately five (5) days after the closing date of this notice, unless the Government determines that another responsible source is capable of meeting the requirement.

Interested parties shall submit capability statements by email to:

Daniel T.

danielt@mail.nih.gov

Responses must be received no later than 9:00 a.m. EDT on September 25, 2026.

Reference Notice No. 75N98026Q01245 in all correspondence.

mailto:danielt@mail.nih.gov