SAM #26-004627

Lease of Avatar Odyssey Instruments from Xcell Biosciences for NIH Clinical Center

This procurement supports advanced cell therapy research at the NIH Clinical Center. - Government Buyer: - Department of Health and Human Services (HHS) - National Institutes of Health (NIH) - Clinical Center, Office of Purchasing and Contracts - Center for Cellular Engineering (CCE) - OEM Highlight: - Xcell Biosciences, Inc. is the sole source and manufacturer of the required equipment - Products/Services Requested: - Lease of four (4) Avatar Odyssey instruments - For a six-month period - Used for process development in cell therapy research - Instruments feature programmable control of oxygen tension and pressure - Designated for research use only - Essential for generating data to inform process optimization and future GMP-compliant system acquisition - Unique/Notable Requirements: - Only Xcell Biosciences can provide the required system and transferable data - Equipment must support compliance with cGMP requirements (21 CFR Parts 210, 211, 600, and 1271) - No other vendors identified as capable of meeting these technical and regulatory needs - Place of Performance: - NIH Clinical Center, Bethesda, MD

Description

Notice of Intent to Sole Source – Lease of Avatar™ Odyssey Instruments (Xcell Biosciences)

NAICS Code: 532490 – Other Commercial and Industrial Machinery and Equipment Rental and Leasing

Product Service Code (PSC):W066 – Lease or Rental of Equipment – Laboratory Equipment

Description:

This is a Notice of Intent, not a request for quotations. A solicitation will not be issued, and quotations will not be requested. This notice is for informational purposes only.

The Department of Health and Human Services (HHS), National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts, on behalf of the Center for Cellular Engineering (CCE), intends to award a firm-fixed-price contract on a sole source basis to:

Xcell Biosciences, Inc.

455 Mission Bay Blvd Suite 124

San Francisco, California 94158-2159

Requirement:

The purpose of this acquisition is to lease four (4) Avatar™ Odyssey instruments for a period of six (6) months to support process development activities within the CCE laboratories located at the NIH Clinical Center, Bethesda, Maryland.

These instruments enable precise control of cellular microenvironment conditions, including oxygen tension (hypoxia to normoxia), pressure, and temperature, which are critical for evaluating and optimizing cell therapy manufacturing processes.

The Center for Cellular Engineering develops and manufactures investigational cell-based therapies for patients with limited or no remaining standard treatment options, in compliance with Current Good Manufacturing Practice (cGMP) requirements (21 CFR Parts 210, 211, 600, and 1271).

Although the instruments are designated for research use only and will not be used for clinical manufacturing, they are essential for generating data that will inform process optimization, improve cell phenotype and function, and support future acquisition of GMP-compliant systems.

Authority:

FAR 13.106-1(b)(1) – Soliciting from a single source when only one source is reasonably available.

Justification for Sole Source:

Market research conducted by the Government determined that Xcell Biosciences, Inc. is the only responsible source capable of providing the required Avatar™ Odyssey system.

The Avatar Odyssey platform is the only commercially available system that integrates programmable control of both oxygen tension and pressure within a single system suitable for cell therapy process development.

No other vendors were identified that can meet these requirements or provide data that is transferable to future GMP-compliant systems.

Period of Performance:

Six (6) months from date of award

Place of Performance:

National Institutes of Health

Clinical Center

10 Center Drive

Bethesda, MD 20892

Response Information:

Interested parties may submit a capability statement demonstrating their ability to meet this requirement. Responses must be received within 10 calendar days of this notice.

Point of Contact:

Team Leader: Shasheshe Goolsby

Email: shasheshe.goolsby@nih

Office of Acquisitions and Logistics Management (OALM)

Disclaimer:

This notice is not a request for competitive quotes.

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