Dynabeads CD3/CD28

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 Government intends to award a fixed price purchase order to: Life Technologies, Corporation, Grand Island, NY 14072.The Cell Processing Section (CPS), Department of Transfusion Medicine, NIH Clinical Center (CC) is an AABB accredited cellular therapy laboratory whose central mission is to provide services to the NIH Institutes to support their intramural clinical trials. These services include (1) performing research aimed at development, evaluation and validation of new manufacturing processes for cellular therapies (2) manufacture of cellular therapy products for approved clinical trials. The majority of these trials are early phase (I/II) trials not intended to result in the development of a commercial product. To provide these services, CPS operates a core facility for the manufacture, storage and distribution of cellular therapy products.

CPS produces clinical therapies from cells collected from NIH CC patients and healthy donors. The products manufactured by the laboratory are used to treat and often cure NIH CC patients with cancer, hematological malignancies, marrow failure, congenital immune disorders and autoimmune diseases. The products are manufactured using US Food and Drug Administration (FDA) guidelines for good manufacturing practices (GMP) and using protocols approved by committees on the use of human subjects in research. Many products manufactured in the CPS laboratory require review and approval for use as an investigational new drug (IND) by the FDA. The IND products include manipulated hematopoietic progenitor cells, lymphocytes, monocytes and natural killer cells. At this time, the Dynabeads CD3/CD28 for ex-vivo isolation, activation and expansion of T cells to treat cancer, autoimmune diseases and/or infectious diseases is only available from Life Technologies.Primary supplies sought:Catalog # Description Quantity40203D Dynabeads CD3/CD28 CTS 10ml 15 vialsThere are no other manufacturers that can be used to isolate, activate and expand of the T Cells that meet rigorous cGMP criteria. The CPS laboratory manufactures approximately 300 highly specific and regulated products each year. These products are used to treat NCI Surgery Branch cancer patients being treated with tumor infiltrating lymphocytes (TIL), NHBI hematology branch hematopoietic transplant patients being treated with stem cells that have minimal T cells capable of causing graft versus host disease, NHLBI hematology branch cancer patients treated with natural killer cells, NCI Experimental Transplantation and Immunology Branch hematopoietic transplant patients being treated with Th2 and Th1 cells, and NCI Pediatric Oncology Branch Patients with sarcoma being treated with donor lymphocyte infusions and dendritic cell vaccines. Contact Information: Andre M. Moody, Contract Specialist, Phone 3014022677, Fax 3015945920, Email moodya@cc.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