FINIA 2. 0 Fill Finish Equipment – Terumo BCT, Inc
Closed Solicitation Posted
- Solicitation number
- 25-005764
- Agency
-
NIH Clinical Center
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 339113 Surgical Appliance and Supplies Manufacturing
- PSC
- 6640 Laboratory Equipment And Supplies
- Place of performance
- Bethesda, Maryland 20892, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institutes of Health (NIH) Clinical Center is seeking to procure one (1) FINIA 2.0 Fill Finish Equipment unit from Terumo BCT, Inc. for its Center for Cellular Engineering (CCE) facilities in Bethesda, MD. This sole source procurement is intended to replace a manual and open cellular therapy preparation process with a more advanced system capable of handling volumes from 2 mL to 100 mL while meeting current Good Manufacturing Practices (cGMP) standards. The equipment will include electronic data recording and reporting features and is critical for preparing and cryopreserving cellular therapy doses with improved safety and precision. The solicitation will be conducted under FAR Part 13 Simplified Acquisition Procedures, which allows for single-source procurement when only one source is reasonably available. Interested parties may submit capability statements electronically to Damien Goines by the May 5, 2025, 9:00 AM (EST) deadline, though the government retains sole discretion on competing the requirement.
The contract opportunity has no specific small business set-aside, and the procurement is valued for a single FINIA 2.0 Fill Finish Equipment unit from the original equipment manufacturer (OEM), Terumo BCT, Inc. located in Lakewood, Colorado. The small business size standard for this NAICS code (339113 - Surgical Appliance and Supplies Manufacturing) is $34 million in average annual receipts. The place of performance will be in Building 10 on the main NIH campus in Bethesda, Maryland, with the equipment supporting cellular engineering laboratories. The procurement aims to mitigate risks associated with manual dose preparation, such as potential delivery of inadequate or excessive cellular therapy doses that could lead to severe side effects like cytokine storms. The contract will be a firm-fixed-price arrangement, and while no specific award value is mentioned, the focus is on acquiring a specialized piece of laboratory equipment critical to cellular therapy research and production.
Notice text
Notice of Intent to Sole Source
Title: FINIA 2.0 Fill Finish Equipment – Terumo BCT, Inc.
POTS: 25-005764
- Product Service Code (PSC): 6640 – Laboratory Equipment and Supplies
- NAICS Code: 339113 – Surgical Appliance and Supplies Manufacturing
(Small Business Size Standard: $34 million average annual receipts) - Place of Performance: Bethesda, MD 20892
This is a Notice of Intent, not a request for quotations. A solicitation document will not be issued, and quotations will not be requested.
The 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 sole source, firm-fixed-price contract to Terumo BCT, Inc., located in Lakewood, Colorado 80215-4440, for the purchase of one (1) FINIA 2.0 Fill Finish Equipment unit.
This equipment will be used in the new CCE cGMP facilities and support laboratories located in Building 10 on the main NIH campus in Bethesda, MD.
The FINIA 2.0 Fill Finish Device is essential for the preparation and cryopreservation of cellular therapy doses. The existing process is manual and open, which presents risks such as delivering inadequate doses or overdoses, which could lead to severe side effects like cytokine storms.
Terumo BCT is the original equipment manufacturer (OEM) and the sole provider of this system. The device is uniquely capable of handling volumes ranging from 2 mL to 100 mL, while meeting current Good Manufacturing Practices (cGMP), and includes electronic data recording and reporting features. No other system on the market offers this full range of capabilities in compliance with cGMP standards
Required Item:
Catalog #
Description
Quantity
32227
FINIA 2.0 Fill Finish Equipment
1
This procurement will be conducted in accordance with FAR Part 13 – Simplified Acquisition Procedures, specifically Subpart 13.106-1(b)(1). Under this authority, for purchases not exceeding the Simplified Acquisition Threshold (SAT), contracting officers may solicit from one source when it is determined that only one source is reasonably available.
Per FAR Part 13, this action is exempt from the competition requirements of FAR Part 6.
Interested parties may submit capability statements in response to this notice. The Government will consider all responses received; however, the decision to compete this requirement remains solely at the discretion of the Government.
All comments or inquiries referencing this notice must be submitted electronically to:
Damien Goines
Contract Specialist, NIH Clinical Center
Email: damien.goines@nih.gov
Deadline: May 5, 2025, at 9:00 AM (EST)
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