Annual Preventative Maintenance and Service Support for Seven (7) Miltenyi CliniMACS Prodigy Instrumentsview on SAM.gov

The National Institutes of Health (NIH), Clinical Center (CC), Department of Transfusion Medicine (DTM), Center for Cellular Engineering (CCE), intends to award a sole-source, firm-fixed-price contract to Miltenyi Biotec, Inc. for annual preventative maintenance and service support of seven (7) CliniMACS Prodigy automated cell-processing instruments, Serial Numbers 0327, 611, 1223, 1326, 1415, 1855, and 917006. Period of Performance: December 1, 2026 – November 30, 2027 These instruments are critical to the manufacture of cell-based therapies for patients participating in clinical trials at the NIH Clinical Center. The equipment operates within Food and Drug Administration (FDA)-regulated Current Good Manufacturing Practice (cGMP) facilities and must be maintained in accordance with applicable regulatory requirements, including 21 CFR 211.63 and 21 CFR 211.67. The required services include annual preventative maintenance, calibration, software updates and patches, inspections, diagnostic testing, troubleshooting, repair support, replacement of proprietary service parts, and technical support necessary to maintain validated operating conditions. The contractor shall provide preventative maintenance reports for each instrument for review and acceptance by the CCE Quality Assurance team. Sole-Source Authority and Justification The Government intends to procure these services on a sole-source basis pursuant to 41 U.S.C. 3304(a)(1) and Revolutionary FAR Overhaul (RFO) FAR 6.103-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. Miltenyi Biotec, Inc. is the original equipment manufacturer (OEM) of the CliniMACS Prodigy instruments and the only known authorized source capable of providing the required preventative maintenance, calibration, software support, and repair services. The CliniMACS Prodigy instruments are proprietary systems requiring manufacturer-specific diagnostic tools, software access, replacement parts, and specialized technical expertise. Market research conducted by the Government identified no alternative sources possessing the necessary proprietary rights, manufacturer authorization, software access, and technical capabilities to perform the required services. The instruments have been qualified and incorporated into validated manufacturing processes supporting patient-specific cellular therapies. Utilizing an unauthorized service provider could compromise equipment qualification, disrupt manufacturing operations, increase regulatory compliance risks, and require extensive and costly requalification activities. Such disruptions could adversely affect ongoing clinical trials and patient treatment schedules. Accordingly, Miltenyi Biotec, Inc. has been identified as the only responsible source capable of satisfying the Government's requirements without jeopardizing validated manufacturing processes, operational readiness, and continuity of patient care. Capability Statement Submission This…