SOLICITATION NOTICE
68 -- Clinical Lot of K562 GM-CSF cells
- Notice Date
- 5/12/2009
- Notice Type
- Combine Synopsis/Solicitation
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- 6120 Executive Blvd. EPS Suite 600 Rockville MD 20852
- ZIP Code
- 20852
- Solicitation Number
- RFQ-NCI-90095-NG
- Response Due
- 5/19/2009
- Archive Date
- 5/20/2009
- Point of Contact
- Malinda L Holdcraft, Contract Specialist, Phone (301) 402-4509, Fax (301) 402-4513, - Caren N Rasmussen, Contracting Officer, Phone (301) 402-4509, Fax (301) 402-4513
- E-Mail Address
-
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. This is a combined synopsis/solicitation for commercial items, prepared in accordance with format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation: No. RFQ-NCI-90095-NG includes all applicable provisions and clauses in effect through FAR FAC 2005-31 (April 2009) simplified procedures for commercial items. The North American Industry Classification System Code is 541380 and the business size standard is $12M. Small businesses are encouraged to apply. Only one award will be made as a result of this solicitation. Statement of Work Contractor Tasks: The Contractor shall produce one clinical lot of K562 GM-CSF cells, including irradiation of the intermediate bulk and cGMP fill and finish. The clinical lot shall be sufficient to facilitate the release of approximately two hundred twenty (220) vials at a concentration of 5 x 1 E 7cells/ml/vial. This irradiation is absolutely necessary for patient safety, as mandated by Center for Biologics Evaluation and Research of the Food and Drug Administration, FDA, to ensure that the cells are viable, yet fully inhibited in their growth. Release testing and final disposition of the clinical lot shall be the responsibility of the Contractor. Release tests to be performed at the Contractor facility include: a. Post-thaw viability b. Expression of relevant cell surface markers (CD71, Glycophorin A) c. GM-CSF levels by ELISA. d. Residual Hygromycin Levels. Release testing to be performed: a. Sterility (21CFR 610.12) b. Mycoplasma (CBER Points to Consider) c. LAL endotoxin Deliverables: A. The clinical lot of K562 GM-CSF irradiated cells, containing approximately 220 vials at a concentration of 5 x 1 E 7 cells/ml/vial. B. The Contractor shall provide a Product Specification and a Certificate of Analysis (COA) for the clinical lot of K562 GM-CSF (irradiated) cells. This information shall be provided to the NCI project officer within 8 weeks of completion of production. C. The Contractor shall provide a copy of the Material Specifications for the growth media and for the components of the directly-injectable cryopreservant. PHASES: 1st phase- Order reagents - 1-2 weeks, from receipt of order. 2nd phase - Cell production and vialing - 13-16 days (must be completed before 06/30/09). 3rd phase - In house testing for GM-CSF secretion and viability post-thaw – (10 days from completion of cell expansion and vialing). 4th phase - Testing for sterility, endotoxin, mycoplasma (To be completed within 8 weeks of production/vialing). 5th phase - Report generation for manufacturing, and regulatory documentation for manufacturing, (including letter of cross-reference to Hy Levitsky's IND) – (within 3 weeks of completion of phase 4). Minimum Contractor Qualifications: NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (12-MAY-2009); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link To Document
(https://www.fbo.gov/spg/HHS/NIH/RCB/RFQ-NCI-90095-NG/listing.html)
- Record
- SN01814920-F 20090514/090512233035 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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