Inactive

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/Departm... 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. The CCE currently utilizes the CliniMACS Prodigy instrumentation from Miltenyi for several clinical trials. The CCE needs to purchase three (3) replacement CliniMACS plus devices with an IQ/PQ package. The CliniMACS Plus Instruments utilizes immunomagnetic techniques to isolate hematopoietic progenitor cells (HPCs), T cells, NK cells, and monocytes. These products are ultimately used for HPC transplantation and for the manufacture of adoptive immunotherapies. Miltenyi Biotec is the sole provider of this proprietary device. This procurement is to replace three older CliniMACS plus devices (Serial# 0562, 0727 and 0728) that are no longer supported by Miltenyi Biotec due to age. CCE manufactures cell-based therapies for patients enrolled on clinical trials at the NIH Clinical Center. The activities of CCE are regulated by the FDA and it is mandated that critical equipment used in the manufacturing, processing and testing of drug product must be maintained in a controlled manner (21 CFR 211.63, 21 CFR 211.67), which requires all equipment be maintained on a preventative maintenance contract. Due to the age of the devices 0562, 0727 and 0728, these devices are no longer supported by Miltenyi Biotec and they will not provide software upgrades and preventative maintenance on these devices. To maintain compliance CCE needs to replace these devices. This is a sole source procurement since Miltenyi Biotec is the sole supplier of these proprietary devices. Miltenyi is also the only vendor able to offer installation and operational qualification packages for these devices. This acquisition is being conducted under the authority of the FAR Subpart 13.106-1(b)(i), Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available. The total dollar value of this purchase order shall not exceed the SAT at $250,000.00. 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