SOLICITATION NOTICE
68 -- Clinical Lot of K562 GM-CSF cells, including irradiation of the intermediate bulk and cGMP fill and finish, to be used for clinical research
- Notice Date
- 6/29/2009
- Notice Type
- Presolicitation
- 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, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- NCI-90121-NG
- Archive Date
- 7/29/2009
- 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
(holdcram@exchange.nih.gov, cr214i@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Cancer Institute (NCI) plans to procure a clinical lot of K562 GM-CSF cells, including irradiation of the intermediate bulk and cGMP fill and finish, to be used for clinical research with Johns Hopkins University (JHU); 733 North Broadway; Baltimore, Maryland 21205. 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 541380 and the business size standard is $12M. Period of Performance shall be from July 20, 2009 through February 28, 20010. Only one award will be made as a result of this solicitation. The purpose of this requirement is to acquire a clinical lot of irradiated K562 cells engineered to secrete human granulocyte macrophage-colony stimulating factor (K562 him-CSF). Contractor shall have facilities that are FDA approved for cell vaccine production. Vaccination of cancer patients with allogeneic tumor cells expressing high levels of multiple CT antigens in combination with depletion of T regulatory cells will induce broad immunity to these antigens. A NCI-IRB approved protocol has been written to examine this issue. Briefly, patients with resectable lung and esophageal cancers, and malignant pleural mesotheliomas will be vaccinated with irradiated K562 erythroleukemia cells expressing GM-CSF (K562 hGM-CSF) following completion of appropriate combined modality therapy. Johns Hopkins University is the only known source, to the NCI, that developed these cells and adapted to growth in serum-free media. These cells are not available from any other known source. In addition, it is not known that other institutions have experience producing these cells for human cancer vaccine trials. JHU is currently conducting three clinical studies using clinical lots of K562 hGM-CSF (Irradiated) Cells produced and released by the Cell Processing and Gene Therapy facility (CPGT) at JHU. These CPGT K562 hGM-CSF (Irradiated) clinical lots have exhibited an excellent safety profile in leukemia patients. Critically, production of this clinical product requires irradiation of freshly harvested cells. The CPGT at JHU has a qualified, maintained cesium irradiator to facilitate the irradiation of fresh bulk cell product, followed by the immediate fill and finish of the bulk cell product into final sterile vials. This irradiation is absolutely necessary for patient safety, as mandated by CBER of the FDA, to ensure that the cells are fully inhibited in their growth. For the consistency of data and patient care, changing variables at this time will be detrimental to current research studies at the NCI. This notice is not a request for competitive quotation. However, if any interested party believes it can meet the above requirement, it may submit a statement of capabilities. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Contractor shall provide one (1) original and one (1) copy of the capability statement. Capability statements must be received in the contracting office by 11:00 AM ET July 14, 2009. All questions must be in writing and can be faxed or emailed to the following: Malinda Holdcraft, Contract Specialist via electronic mail at holdcram@exchange.nih.gov or fax 301-402-4513. It is the contractors’ responsibility to ensure all questions have been received in the contracting office. 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. No faxed or emailed capability statements will be accepted. In order to receive an award, contractors must be registered and have valid certifications in the Central Contractor Registration (CCR) and the Online Representations and Certification Application (ORCA). Please reference NCI-90121-NG on all correspondence.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/NCI-90121-NG/listing.html)
- Place of Performance
- Address: Baltimore, MD, United States
- Record
- SN01860221-W 20090701/090630000916-bb32c9038180b2d30a278391ca8f6a88 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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