Miltenyi CliniMACS Prodigy Instruments for the Center for Cellular Engineering cGMP Facility

This is a notice of intent, not a request for a quotation. A solicitation document will not be issued and quotations will not be requested.

The National Institutes of Health (NIH) intends to award a fixed price contract with a twelve (12) month base year to Miltenyi Biotec, Inc., Auburn, CA 95602 on a sole source basis to provide two CliniMACS automated cell separator units to the Department of Transfusion Medicine (DTM), Center for Cellular Engineering (CCE) at the NIH Clinical Center (CC).

The purpose of this requirement is to acquire the equipment needed for the activation of the new Center for Cellular Engineering Current Good Manufacturing Practices (cGMP) Facility. The equipment needed are two CliniMACS cell separator units that will complement the CliniMACS equipment currently located in the other CC Center for Cellular Engineering facilities, for consistency and reproducibility of results and provide simplified program management. The CliniMACS Integrated Cell Separation and Incubation Devices will be utilized for the processing of items such as final products, and product intermediates at the CCE/Clinical Center 12E cGMP Clinical Cell Processing Facility.

Miltenyi Biotec, Inc. is the only source that meets the capability and performance requirements. The CliniMACS is the only closed loop, fully automated cell isolation system with pre-programmed selection and depletion protocols. The system is comprised of an integrated computer, a magnetic separation unit, a peristaltic pump, a liquid sensor and pinch valves. The system is part of the NIH FDA submissions; there are no substitutions allowed as to do so would require halting trials and performing qualifications and validations to show that any other vendor was capable of producing the same results, which would take a long time and require a large financial investment, not to mention it would delay the treatment of patients who have exhausted all other treatment options. The CliniMACS® System is not sold through distributors, or other commercial outlets in the United States or Canada.

This acquisition is being conducted using policies unique to the Federal Acquisition Regulation (FAR) Part 13 – Simplified Acquisition Procedures, Subpart 13.106-1(b)(1), For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available.  Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements.

Interested parties may identify their interest and capabilities in response to this posting. The determination by the Government not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government.

Comments to this announcement, referencing this posting number, may be submitted to the CC, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Kerry-Ann Chisholm, Contract Specialist, kerry-ann.chisholm@nih.gov by the due date and time marked in this notice.