CliniMacs Prodigy Instrument and Installation for Cellular Engineering

The National Institutes of Health (NIH) intends to award a fixed priced purchase order on a sole source basis to Miltenyi Biotec, Auburn CA, 95602-9562, DUNS 808605919 for the Clinical Center/Department of Transfusion Medicine/Center for Cellular Engineering (CCE). CCE is an AABB accredited cellular therapy laboratory whose central mission is to provide services to the NIH Institutes to support more than 50 intramural clinical trials. CCE is responsible for the manufacture of human cells and tissue-based products utilized in Phase I/II clinical protocols for transplantation, adaptive immunotherapy and gene therapy conducted in the Clinical Center at the NIH.

Cell processing procedures are tailored to each of the many protocols supported in the Center for Cellular Engineering. The CCE manufactures cell based therapies for patients who either have none, or have exhausted all other standard treatment options. The manufacturing operations are regulated by the Current Good Manufacturing Practices (cGMPs) as mandated by the FDA in 21 CFR 210, 211, 600 and 1271.

CCE currently utilizes the CliniMACS Prodigy instrumentation from Miltenyi for several clinical trials. An additional device is needed to increase the capacity of the Center for Cellular Engineering's manufacturing facilities. CCE is moving to closed system, automated devices to improve the throughput and consistency of the cell therapies we manufacture. To procure a different device would compromise clinical trials as it would impact consistency and require extensive testing for comparability that would introduce delays to critically ill patients receiving treatment.

The following Clinical Trial products are manufactured using the Prodigy

Bispecific (loop) CD19/CD22 CAR T-cell 18-C-0059

GPC3 CAR T-cell

TSLPR CAR T-cell

FGFR4 CAR T-cell

Bicistronic 19/22 CAR T-cell

Her2 Dendritic cell manufacturing

The proposed vendor, Miltenyi Biotec, Inc. is the only known vendor that can supply the proprietary instrument, CliniMACS Prodigy. This acquisition is being conducted using policies unique to the authority of the test program for commercial items prescribed in FAR Subpart 13.501 sole source (including brand name) acquisitions. Interested concerns capable of providing the same or similar products or services as described in this notice may submit a capability statement outlining their capabilities. Capability Statements must be received within the time set forth in this synopsis to be considered by the Government. A determination to compete this proposed contract based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.

Each response should include the following Business Information:
a. DUNS.
b. Company Name, address, POC, Phone and Email address
c. Current GSA Schedules or NAICS codes appropriate to this Award.
d. Type of Company (i.e., small business, 8(a), woman owned, hubZone, veteran owned, etc.) as validated in System For Award Management (SAM). All offerors must register on the SAM located at http://www.sam.gov/portal/SAM/#1
e. Capability Statement

Comments to this announcement may be submitted to the Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Malinda Dehner, Contract Specialist, dehnerm@cc.nih.gov by the due date and time marked in this notice.