NIH intends a sole-source award to Global Life Sciences Solutions USA LLC / Cytiva for preventative maintenance and FullCare service support for six Cytiva Sepax C-PRO closed cell separation systems used in FDA-regulated cGMP cell-therapy manufacturing. The anticipated period of performance is December 18, 2026 through December 17, 2027. Services include preventive maintenance, calibration, inspections, software updates, troubleshooting, repair support, proprietary parts replacement, technical support, and maintenance documentation for CCE Quality Assurance review. The sole-source basis is that Cytiva is the OEM and only known authorized source with proprietary software, diagnostic tools, parts, and technical expertise; alternate providers could compromise validated processes and require requalification. Responsible sources may submit capability statements demonstrating manufacturer authorization, access to proprietary diagnostic software and parts, and ability to maintain validated operating conditions under FDA and cGMP requirements.