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 service support for seven (7) Miltenyi Biotec CliniMACS Plus instruments from Miltenyi Biotec, Inc. The requirement supports the continued operation of critical cell-processing equipment used in manufacturing patient-specific cellular therapies for patients enrolled in clinical trials at the NIH Clinical Center. CCE manufactures cell-based therapies under Food and Drug Administration (FDA)-regulated Current Good Manufacturing Practice (cGMP) conditions. The requirement includes preventative maintenance, calibration, inspections, software updates, diagnostic testing, troubleshooting, repair support, replacement of proprietary service parts, and technical support for CliniMACS Plus instruments bearing serial numbers 2600, 2602, 2632, 2635, 2634, 2619, and 2756. These services are necessary to maintain equipment reliability, validated manufacturing processes, and compliance with applicable FDA regulations, including 21 CFR 211.63 and 21 CFR 211.67. Basis for Intended Sole Source Miltenyi Biotec, Inc., is the original equipment manufacturer and the only known authorized provider capable of performing the required preventative maintenance, calibration, and technical support services for the CliniMACS Plus instruments. The equipment incorporates proprietary software, diagnostic tools, replacement parts, and manufacturer-specific technical requirements that are not available to unauthorized third-party service providers. The seven instruments have been qualified and incorporated into validated manufacturing processes supporting patient-specific cellular therapies. Utilizing an alternate service provider without the required manufacturer authorization, proprietary software access, and technical expertise could compromise equipment performance, jeopardize regulatory compliance, and require costly requalification activities. Any disruption to these critical instruments could delay manufacturing operations and patient treatment schedules. Accordingly, NIH intends to award this requirement to Miltenyi Biotec, Inc., on a sole-source basis to ensure continued operational readiness and compliance with FDA-regulated manufacturing requirements. The proposed contractor is: Miltenyi Biotec, Inc. 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 service support for the seven Miltenyi Biotec CliniMACS Plus 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. Vendors must also demonstrate their ability to maintain the instruments' validated operating conditions and provide preventative maintenance reports for review by the CCE Quality Assurance team. All capability statements must be received no later than November 4, 2026, at 7:00 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. No solicitation package is available at this time. This notice does not constitute a solicitation, and the Government will not reimburse respondents for costs associated with preparing or submitting a response.
