CELL PROCESSING REAGENTS FOR TRANSFUSION MEDICINE
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: 34Unit: Vial
This acquisition is being conducted using policies unique to the acquisition of commercial items prescribed in FAR Part 12, in conjunction with the policies and procedures for the competition requirements of Part 6. 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 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 Malinda Dehner, Contract Specialist, [email protected] by the due date and time marked in this notice.
Malinda Dehner, Contracting Specialist, Phone 301-594-6320, Email [email protected] - Barbara Taylor, Contracting Officer, Phone 301-594-5915, Fax 301-594-5920, Email [email protected]
