SOURCES SOUGHT
68 -- BL22
- Notice Date
- 5/23/2005
- Notice Type
- Sources Sought
- NAICS
- 325412
— Pharmaceutical Preparation 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
- N02-RC-57016-16
- Response Due
- 7/7/2005
- Archive Date
- 7/22/2005
- Description
- The Laboratory of Molecular Biology (LMB), Centers for Cancer Research Branch (CCR), National Cancer Institute (NCI), intends to procure 2 grams of BL-22, and immunotoxin developed by LMB and produced under license by a Cooperative Research and Development Agreement (CRADA) partner, Daiichi Pharmaceutical Company. Daiichi shall provide 2.0 grams of the agent BL-22. These 2.0 grams shall pass all FDA required tests, meet all specifications for batch lot release, and have no deviations from the manufacturing protocols supplied to ABL by Daiichi. The FDA required tests include: 1) Forph, protein concentration determined by Absorbance at 280nm and dye-binding assay; 2) purity determined by SDS-PAGE with Coomassie Blue and silver staining; 3) purity determined by HPLC-SEC; 4) identity determined by N-terminal amino acid sequencing or peptide mapping; 5) sterility; 6) CD22 binding; 7) USP test for Particulates; 8) Potency determined by cytotoxicty assay on Raji cell line; 9) Container Closure Integrity; 10) free thiol determination and; 11) the preparation must be shown to have acceptable levels of E.Coli host cell DNA and E.coli host cell protein contamination. All paperwork, computer discs, and any other form of document storage that the FDA requires for the use of the drug in human clinical trials shall be provided at time of purchase. Specifications for all acceptable testing results shall be provided when the manufacturing of the BL-22 product is completed. All raw data from all required tests shall be provided. Daiichi shall provide the bulk BL-22 product and all documentation, information, test results and data at the same time, upon completion and successful results of all testing. Number Note 22 applies as follows: The proposed contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source under the authority of 41USC 253 (c) (1) as set forth in FAR 6.302-1. It is anticipated that a 60 day fixed price contract will be made. Interested persons may identify their interest and capability to respond to the requirement or submit proposals. This notice of intent is not a request for competitive proposals. However, all proposals received within forty-five days after date of publication of this synopsis will be considered by the government. All information furnished should be in writing and must contain information in sufficient detail to allow the NCI researcher to determine if the party can meet the above requirements. If you have any questions, please contact Annmarie Keane, Contract Specialist on (301) 435-3814. 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.
- Record
- SN00813610-W 20050525/050523211736 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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