Closed Solicitation · DEPARTMENT OF HEALTH AND HUMAN SERVICES
AI Summary
The Department of Health and Human Services intends to award a sole source contract to Xcell Biosciences for leasing four Avatar™ Odyssey instruments for six months. These instruments are essential for process development in cell therapy, providing precise control of cellular microenvironment conditions. Interested parties may submit capability statements within 10 days of this notice.
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.
NOTICE OF INTENT TO SOLE SOURCE – LEASE OF AVATAR™ ODYSSEY INSTRUMENTS (XCELL BIOSCIENCES) is a federal acquisition solicitation issued by DEPARTMENT OF HEALTH AND HUMAN SERVICES. Review the full description, attachments, and submission requirements on SamSearch before the response deadline.
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