FINIA 2.0 Fill Finish Equipment – Terumo BCT, Inc

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)