SOLICITATION NOTICE
66 -- CliniMacs
- Notice Date
- 2/1/2005
- Notice Type
- Solicitation Notice
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- Reference-Number-NCI-50024-NV
- Response Due
- 2/11/2005
- Archive Date
- 2/26/2005
- Description
- The National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR) Surgery Branch (SB), Cell Production Facility (CPF) intends to procure on a sole-source basis for a large scale clinical grade cell separation apparatus from Miltenyi Biotec Inc., 12740 Earhart Avenue, Auburn, CA 95602. The SB/NCI has an ongoing clinical program using adoptive cell transfer therapy for the treatment of patients with metastatic cancer. The Cell Production Facility of the SB/NCI uses sophisticated immunological and cell biological methods to identify tumor reactive T lymphocytes from patients with cancer, and expand them to numbers in the tens of billions while retaining their anti-tumor function. The improvement of cell transfer therapy and its wider application comprise a primary goal of the SB/NCI and they are currently recruiting patients for five clinical protocols investigating cell transfer therapies for the treatment of patients with metastatic cancer. These protocols will examine the use of genetically altered lymphocytes, superior conditioning regimens, and concurrent vaccination with cell transfer therapy. To investigate the specific cell populations responsible for causing tumor regression in treated patients, the SB/NCI intends to amend our clinical protocols to allow the enrichment of specific lymphocyte populations prior to cell infusion into patients. To achieve this enrichment it is necessary to obtain a system that meets the following specifications: 1) it must be capable of CD8 enrichment to greater than 95% purity; 2) it must be capable of CD25 depletion to less than 1% of cells; 3) the system must have capacity for cell numbers between 1 x 108 to 3 x 1011 cells; 4) the system must have reagents and protocols consistent with purification of cells under Good Manufacturing Procedures (GMP); 5) the system must be ?closed,? and fully automated and yield a sterile cell product; and 6) the supplier must have Master Files with the Food and Drug Administration (FDA) that can be cross-referenced for use of CD8 and CD25 reagents. Miltenyi Biotec is the only source known to NCI researcher that has the aforementioned features. This is not a solicitation for competitive quotations. However, if any interested party believes it can meet the entire above requirement, they may submit a statement of capabilities. All information furnished shall be in writing and must contain sufficient detail to allow the NCI researcher to determine if it can meet the requirements of this synopsis. This acquisition will be processed under FAR Part 12 ? Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.5 to use simplified procedures for commercial acquisitions. An original and one copy of the capability statements must be received in the Contracting Office by 1PM EST (local Washington, D.C. time) on February 11, 2005. Emailed and faxed capability statements are NOT authorized. All questions must be in writing and may be emailed to Debbie Moore at dm170b@nih.gov or faxed (301) 402-4513. It is the vendor?s responsibility to call (301) 402-4509 and verify that questions were received. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. NAICS: 334516; Size Standard is 500 employees.
- Place of Performance
- Address: Bethesda, Maryland
- Zip Code: 20892
- Record
- SN00743363-W 20050203/050201211747 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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