Annual Preventative Maintenance and Service Support for Seven (7) Miltenyi CliniMACS Prodigy Instruments
The NIH Clinical Center’s Department of Transfusion Medicine/Center for Cellular Engineering intends to award a sole-source, firm-fixed-price contract to Miltenyi Biotec, Inc. for annual preventive maintenance and service support of seven CliniMACS Prodigy automated cell-processing instruments used in FDA-regulated cGMP cell-therapy manufacturing at the NIH Clinical Center. The period of performance is December 1, 2026 through November 30, 2027. Required services include preventive maintenance, calibration, software updates, inspections, diagnostic testing, troubleshooting, repair support, proprietary parts replacement, technical support, and maintenance reports for CCE Quality Assurance acceptance. The Government justifies sole-source award because Miltenyi is the OEM and only known authorized source with the proprietary tools, software access, parts, and expertise needed to maintain validated manufacturing processes and avoid regulatory and requalification risks. Although this is not a request for competitive quotations, responsible sources may submit capability statements demonstrating manufacturer authorization, proprietary access, relevant experience, cGMP compliance, and ability to support operations without disruption.