Korus™ CFC-150 Including Installation and Initial testing for the Department of Transfusion Medicine

This is a notice of intent, not a request for a quotation. A solicitation document will not be issued and quotations will not be requested.

The National Institutes of Health (NIH) intends to award a fixed price contract to Invetech, Inc., San Diego, California 92121 on a sole source basis to provide one (1) Korus™ CFC-150 and KArRT Including Installation, Initial testing, IQ/OQ support for the Department of Transfusion Medicine (DTM), Center for Cellular Engineering (CCE) at the NIH Clinical Center (CC).

The purpose of this requirement is to acquire the equipment needed for the replacement of older Terumo Elutra devices, that will no longer be supported by the vendor in 2023.  The devices will be installed in the CCE cGMP facilities that are located in building 10 on the main NIH campus. Terumo will no longer be providing support for the older Elutra devices moving forward, the existing devices need to be replaced. Due to the age of these devices, there is no longer a reliable supply of parts and the software that controls the devices cannot be upgraded, as consequence Terumo can no longer offer the preventative maintenance that is mandated by the FDA. This procurement is for the purchase of devices that can be fully maintained in accordance with regulations. These are critical devices that are used process/manufacture therapies to support patients with limited treatment options.

Invetech, Inc. is the only known source that meets the capability and performance requirements. CCE routinely needs to elutriate cells from apheresis products as both an integral step in ongoing Phase I/II clinical human trials, as well as a weekly service provided to research investigators for protocol development within the Clinical Center. Over the last thirty years, these elutriations have been performed on the Terumo Elutra, a platform that will be phased out by Terumo within the next two years. Compared to other available elutriation devices currently on the market,  Invetech Korus™ Counterflow Elutriation System is the only known device that is a suitable replacement and compatible with current regulations on GMP production of cell therapies, but with significant improvements. 

This acquisition is being conducted using policies unique to the Federal Acquisition Regulation (FAR) Part 13 – Simplified Acquisition Procedures, Subpart 13.106-1(b)(1), For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available.  Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements.

Interested parties may identify their interest and capabilities in response to this posting. The determination by the Government not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government.

Comments to this announcement, referencing this posting number, may be submitted to the CC, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Tasha Lowe, Contract Specialist, lowet2@mail.nih.gov by the due date and time marked in this notice.