Cell processing reagents for transfusion medicine

Added: May 12, 2016 12:05 pm 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 fixed price purchase order to Life Technologies, Carlsbad, CA 92008 on a sole source basis to procure Dynabeads reagents for the preparation of highly purified unique immunotherapy products for treatments of critically ill patients for the Cell Processing Section (CPS) of the Department of Transfusion Medicine. The Cell Processing Section (CPS) is responsible for the manufacture of human cells and tissue-based products utilized in phase I/II clinical protocols for transplantation, adoptive immunotherapy and gene therapy conducted in the Clinical Center at the NIH. Patients are enrolled in approved clinical protocols. The Dynabeads are used for stimulation of cells in culture.

At this current time there is no other known supplier of the Dynabeads reagents. Per Federal Drug Administration (FDA) approval, the Cellular Therapy Laboratory (CTL) must use the selected Life Technologies product in the preparation of highly purified immunotherapy for critically ill cancer patients. These patients are enrolled in FDA and Institution Review Board (IRB) approved clinical protocols #04C0055, 08C0088, and 11C0016. FDA regulations prohibit the substitution of any reagents or process without preapproval. The product information is listed below:

Item#: 40203D
Description: DYNABEADS CD3/CD28 CTS 10ml
Quantity: 32 Unit: Vial

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. 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.