SOLICITATION NOTICE
B -- Biosafety testing of master cell banks and retroviral vector supernatants
- Notice Date
- 10/21/2008
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- 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, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- NCI-90004-NG
- Archive Date
- 11/15/2008
- Point of Contact
- Malinda L Holdcraft,, Phone: (301) 402-4509, Caren N Rasmussen,, Phone: (301) 402-4509
- E-Mail Address
-
holdcram@exchange.nih.gov, cr214i@nih.gov
- Small Business Set-Aside
- N/A
- Description
- National Cancer Institute (NCI) plans to procure on a sole source basis, biosafety testing of master cell banks and retroviral vector supernatants with BioReliance, 14920 Broschart Road, Rockville, MD 20850. The supplies and services herein are commercial as described in FAR Part 12 and the supplies and services are being procured in accordance with the simplified acquisition procedures authorized by FAR Part 13.501. The North American Industry Classification System Code is 541710 and the business size standard is 500 employees. The purpose of this requirement is to acquire biosafety testing services for release of retrovirus-producing master cell banks and clinical grade retroviral vector generated within the NCI. Contractor shall comply with good manufacturing practices (GMP). There is currently a need for the development of new and more effective immunotherapies for the treatment of patients with melanoma as well as a variety of other cancers that are refractory to current treatments. The majority of patients with advanced metastatic cancer now enrolled in the NCI clinical trials have failed conventional and most experimental treatments such as chemotherapy, treatment with cytokine proteins, vaccination with tumor antigen peptides and recombinant viruses that encode tumor antigens. The retrovirus-producing master cell banks and clinical grade retroviral vector generated within the NCI will support clinical protocols within NCI such as adoptive transfer of tumor reactive T cells. NCI patients with metastatic melanoma have a median survival time of six (6) months, and patients rarely survive longer than three (3) years. Between three hundred (300) and four hundred (400) new patients with metastatic melanoma are now being treated in the NCI each year. Period of Performance shall be from award through eight (8) months. BioReliance Corporation is the only known source to the NCI that is a comprehensive facility capable of supplying the necessary biosafety testing of our master cell bank and retroviral vectors. BioReliance has developed and validated a rigorous series of safety testing protocols with significant Quality Assurance and Quality Control (QA/QC) oversight in accordance with accepted regulatory guidelines. In addition, the proposed clinical trials may have a direct impact on patient survival, and it is therefore crucial that these services be obtained without delay. The need to develop experiment protocols and verify that these procedures can be utilized for larger clinical trials is essential to the development of life-saving therapies. This is not a request for competitive quotation. However, if any interested party believes it can perform the above requirement, it may submit a statement of capabilities. The statement of capabilities and any other furnished information must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform this requirement. Capability statements must be received in the contracting office by 11:00 AM ET October 31, 2008. Questions must be submitted in writing to Malinda Holdcraft, Contract Specialist, at holdcram@exchange.nih.gov or by fax 301-402-4513. A determination by the Government not to compete this proposed requirement 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. In order to receive an award, contractors must be registered and have valid certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Application (ORCA). Please reference solicitation number NCI-90004-NG on all correspondence.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=57f157db37aae1fbe34699b1ebdd82c3&tab=core&_cview=1)
- Record
- SN01694583-W 20081023/081021221244-57f157db37aae1fbe34699b1ebdd82c3 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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