SOLICITATION NOTICE
H -- Testing of CD64, HLA-A2, 4-1BBL Master Cell Bank.
- Notice Date
- 8/8/2007
- Notice Type
- Solicitation Notice
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-NCI-70110-NV
- Response Due
- 8/17/2007
- Archive Date
- 9/1/2007
- Description
- The National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer (CCR) Research, Pediatric Oncology Branch (POB), Immunology Section (IS) intends to procure on a sole-source basis with AppTec, 2540 Executive Dr., St. Paul, MN 55120 for Testing of CD64, HLA-A2, 4-1BBL Master Cell Bank. The mission of the Immunology Section of the Pediatric Oncology Branch is to develop effective immune based therapies for childhood cancer. Previous work has demonstrated that commonly administered cancer therapies induce profound lymphocyte depletion in children treated for cancer and that the period of lymphopenia can be exploited for therapeutic gain if sufficient numbers of tumor reactive lymphocytes can be administered. The POB has previously identified and published evidence demonstrating that T cells generated using artificial antigen presenting cells (aAPCs) expressing 4-1BBL are very potent at responding to pediatric tumors. A major goal of the POB's research program is to administer T cells generated via aAPCs to pediatric cancer patients rendered lymphopenic by cytotoxic therapy. The Cell and Vaccine Research Center at the Abramson Cancer Institute at the University of Pennsylvania invented the 4-1BBL expressing aAPC and is an active research collaborator with the POB. In collaboration with investigations at the Cell and Vaccine Research Center at the University of Pennsylvania, the POB generated a clinical grade master cell bank of 4-1BBL expressing aAPCs which also coexpress CD64 (the high affinity Fc receptor) and HLA-A2. These cells potently expand antigen specific T cell populations. Prior to use in clinical trials this master cell bank must undergo a series of rigorous tests for quality control and sterility as dictated by the US Pharmacopoeia and US FDA requirements. The creators of this master cell bank, the Cell and Vaccine Research Center at the University of Pennsylvania have recently generated master cell banks expressing several of the same molecules used in the POB?s product. Apptec has already performed the quality control testing on these cell banks and therefore has unique experience and expertise in the evaluation of this product. If POB were to use an alternative contractor, there would be significant introduction of new variables into the analyses which could adversely affect the ability to interpret results. This is a continuation of an on-going research and it is essential that the cell bank be processed by the same laboratory in order not to introduce new variables into on-going clinical trial. 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 NINDS 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 2PM EDT (local Washington, D.C. time) on August 17, 2007. Faxed and emailed 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. In order to receive an award from the NCI contractors must be registered in the Online Representations and Certifications Applications (ORCA) in order to receive an award. Please refer to http://orca.bpn.gov in order to register. In addition, contractors must be registered in the Central Contractor Registration (CCR) www.ccr.gov. No collect calls will be accepted. NAICS: 541380; Size Standard is $11 million.
- Record
- SN01365675-W 20070810/070808220656 (fbodaily.com)
- Source
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