SOLICITATION NOTICE
68 -- Laboratory services: Recombinant E-selectin
- Notice Date
- 7/6/2004
- Notice Type
- Solicitation Notice
- NAICS
- 325414
— Biological Product (except Diagnostic) 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
- RFQ-NCI-40098-NV
- Response Due
- 7/20/2004
- Archive Date
- 8/4/2004
- Point of Contact
- Deborah Moore, Purchasing Agent, Phone (301) 402-4509, Fax (301) 402-4513, - Renita Smith, Contract Specialist, Phone 301-496-8612, Fax 301-480-0241,
- E-Mail Address
-
dm170b@nih.gov, rs442i@nih.gov
- Description
- The National Cancer Institute (NCI) on behalf of the National Institute of Neurological Disorders and Strokes (NINDS), Clinical Investigation Section, Stroke Branch, Clinical Neuroscience Program Division of Intramural Research is soliciting to attain clinical grade production of recombinant human E-selectin. This shall be achieved within clinical good manufacturing practice standards in sufficient volume for use in two (2) clinical trials for two (2) indications. The supplies and services herein are commercial as defined in FAR Part 2, and this acquisition is being made in accordance with the test program using simplified procedures for commercial items as authorized in FAR 13.5. The North American Industry Classification System Code (NAICS) codes and business size standards are as follows: NAICS code 325414, business size standard 500 employees, NAICS code 325411, business size standard 750 employees and NAICS code 325412, business size standard 750 employees. The cloning and expressing is to be done in insect or CHO cells. Molecular mass specifications are open at the time. Recombinant E-selectin shall be purified and tested for safety, purity, identity, strength and potency. The purified E-selectin shall be >96% pure, sterile, and shown to be free of contaminating mycoplasma, spiroplasma, endotoxin (< 10 EU/ml), and infectious baculovirus. The purified protein shall be used to generate serum antibody that recognizes recombinant E-Selectin protein. This serum can be successfully used for identification and traceability purposes in the protein purification process. The contractor shall provide to the Federal Drug Administration (FDA) required documentation per 21 CFR 312.22 and 312.23 for human E-selectin in nasal spray formulation in three (3) dosages, in a timeframe allowing for production of the protein and submittal and approval of an Investigational New Drug (IND) application to the FDA for start of Clinical trials no later than March 2005. The specific stroke project is NINDS protocol number 03-N-0293, "Induction of Mucosal Tolerance to Human E-selectin for the Secondary Prevention of Stroke." The National Heart , Lung and Blood Institute (NHLBI) acute coronary study titled "Evaluation of Induction of Mucosal Tolerance on Myocardial Infarction" does not yet have an NHLBI protocol number. The design follows closely with the outline of the NINDS study. Solicitation# will be issued on 21 Jul 04 with responses due on 10 Aug 04. Sources requesting a copy of the solicitation package are required to submit a written request to the address indicated above. Requests may be emailed to Deborah Moore, Purchasing at dm170b@nih.gov or faxed to 301-402-4513. No telephone requests for solicitation packages will be accepted.
- Place of Performance
- Address: Bethesda, MD
- Zip Code: 20892
- Country: USA
- Zip Code: 20892
- Record
- SN00615450-W 20040708/040706211641 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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