The National Institutes of Health (NIH), Clinical Center (CC), Department of Transfusion Medicine (DTM), Center for Cellular Engineering (CCE), intends to procure preventative maintenance and FullCare service support for six (6) Cytiva Sepax C-PRO closed cell separation systems from Global Life Sciences Solutions USA LLC / Cytiva. The anticipated period of performance is December 18, 2026 – December 17, 2027. CCE manufactures cell-based therapies for patients enrolled in NIH-sponsored clinical trials. These manufacturing activities are conducted under Food and Drug Administration (FDA)-regulated Current Good Manufacturing Practice (cGMP) conditions. The Sepax C-PRO instruments are critical to validated manufacturing processes and require preventative maintenance, calibration, and technical support to ensure continued operational readiness and regulatory compliance. The requirement includes preventative maintenance, calibration, inspections, software updates, troubleshooting, repair support, replacement of worn or proprietary service parts, and technical support for the following six (6) Sepax C-PRO instruments: 29264741-6995.4290 29264741-6994.4253 29264741-7133.4253 29264741-8298.2213 29264741-8299.2213 29264741-8300.2213 The contractor shall ensure the equipment operates within manufacturer specifications and provide preventative maintenance documentation for review and approval by the CCE Quality Assurance team. These services are necessary to maintain compliance with applicable FDA regulations, including 21 CFR 211.63 and 21 CFR 211.67. Basis for Intended Sole Source The Government intends to award this requirement on a sole-source basis to Global Life Sciences Solutions USA LLC / Cytiva pursuant to the authority of 41 U.S.C. 3304(a)(1), as implemented by Revolutionary Federal Acquisition Regulation Overhaul (RFO) FAR 6.103-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. Global Life Sciences Solutions USA LLC / Cytiva is the original equipment manufacturer (OEM) and the only known authorized source capable of providing the required preventative maintenance, calibration, software support, and repair services for the six (6) Sepax C-PRO instruments. These instruments incorporate proprietary software, diagnostic tools, and replacement parts requiring manufacturer-specific technical expertise and authorized access. Market research confirmed that no alternate vendors possess the necessary proprietary rights, manufacturer authorization, or technical capabilities to perform the required services. Utilizing an alternate service provider could compromise validated manufacturing processes, require costly requalification activities, and potentially delay patient treatment schedules. Accordingly, NIH intends to procure these services from Global Life Sciences Solutions USA LLC / Cytiva on a sole-source basis. Capability Statements This notice is not a request for competitive quotations or proposals. However, responsible sources that believe they can satisfy the Government's requirement may submit a capability statement demonstrating their ability to provide the required preventative maintenance, calibration, and FullCare service support for the six (6) Sepax C-PRO instruments. Capability statements should clearly demonstrate the vendor's technical qualifications, manufacturer authorization, access to proprietary diagnostic software and replacement parts, and ability to perform the required services in accordance with applicable FDA and cGMP requirements. Interested vendors must also demonstrate their ability to maintain the instruments' validated operating conditions, provide necessary software updates and replacement parts, and furnish preventative maintenance reports for review by the CCE Quality Assurance team. All capability statements must be received no later than November 4, 2026, at 8:00 AM Eastern Time (ET). The Government will consider all responses received by the stated deadline. A determination not to compete this proposed acquisition based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for determining whether to conduct a competitive procurement.
