Notice of Intent to Sole Source – Cytiva 26-001651
Summary
AI-generated · Mar 20, 2026Upgrade software for SmartRedux Sepax 2 protocol on Sepax C-PRO equipment used in manufacturing R&D of cell-based therapies for NIH-sponsored clinical trials at the NIH Clinical Center. The upgrade will be provided as a fixed-price purchase order.
Award is sole-source to Global Life Sciences Solutions USA LLC, doing business as Cytiva, the original equipment manufacturer and sole distributor. FDA requirements mandate that all repairs and software upgrades be performed by qualified Cytiva technicians, making Cytiva the only source qualified to service and upgrade these devices. This procurement will be conducted under FAR Part 13 Simplified Acquisition Procedures and is not a competitive solicitation; responses may be submitted by interested parties as described in the posting by the closing date.
This acquisition is for SmartRedux Sepax 2 protocol software upgrade for the Sepax C-PRO equipment that will be used in manufacturing research and development of cell-based therapies for patients enrolled on NIH sponsored clinical trials at the National Institutes of Health (NIH) Clinical Center (CC). Product Service Code: 6515 Medical Instruments, Equipment, and Supplies NAICS Code: 512310 Software Publishers Place of Performance: Bethesda, MD 20892 USA POTS: 26-001651 Description: 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 purchase order to Global Life Sciences Solutions, on a firm fixed price sole source award basis to provide software upgrades to the National Institutes of Health. Global Life Sciences Solutions USA LLC is doing business as Cytiva. Cytiva is the original equipment manufacturer and the sole distributor of their equipment and supplies. The FDA mandates that all repairs and maintenance are carried out by qualified technicians. Cytiva/Global Life Sciences Solutions USA LLC is the only source of technicians qualified to service these devices and upgrade their software. 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 NIH, Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, to the attention of Kristin Nagashima, Contract Specialist via email to Kristin.nagashima@nih.gov by March 26, 2026 at 11am EST.
From Special Notice posted on Mar 19, 2026Notice history
1Details
Award Information
Not yet awarded
Contacts
Agency
Place of Performance
USA