FDA 510(k) cleared T-cell medium for cell culture processing applications

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 Institute of Health (NIH), Clinical Center (CC) intends to award a firm-fixed price purchase order to Life Technologies Corporation, a Thermo Fisher Scientific Company (Large Business) Carlsbad, CA 92008-7321 on a sole source basis to procure seventy (70) CTSTM AIM V® SFM that are used in the Cell Processing Section of the Department of Transfusion Medicine.Life Technologies Corporation, is the only known vendor that manufactures the GIBCO® CTSTM AIM V® SFM (Therapeutic Grade) defined, serum-free medium (SFM) for the proliferation and/or manipulation of T cells and dendritic cells manufactured in compliance with cGMP. This CTSTM AIM V® SFM is an FDA 510(k) cleared device intended for human ex-vivo tissue and cell culture processing applications. It contains L-glutamine, 50 µg/mL streptomycin sulfate, and 10 µg/mL gentamicin sulfate.

The required media is used to expand autologous and allogenic Chimeric antigen Receptor (CAR) anti-CD10 cell products that are used to treat patients with B cell malignancies. Many of these patients have already begun a series of CAR cell treatments that would be interrupted if this were not available. The media must come from the same vendor so as to ensure consistency and not introduce a new media which could be responsible for potentially altering the results and adversely affect the processing of cells and a patient's treatment plan.This acquisition is being conducted under the authority of the FAR Subpart 13.106-1(b). 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. Information received will be evaluated for the purpose of determining whether to conduct a competitive procurement. 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 addressc. 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/#1e. Capability StatementComments 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 noticeContact Information: Malinda Dehner, Lead Contract Specialist, Phone 301-594-6320, Email dehnerm@cc.nih.gov - Barbara Taylor, Contracting Officer, Email Barbara_Taylor@nih.gov Office Address :6707 Democracy Blvd, Suite 106, MSC 5480 Bethesda MD 20892-5480 Location: Clinical Center/Office of Purchasing & Contracts Set Aside: N/A