SOURCES SOUGHT
A -- MONOCLONAL ANTIBODIES USING MAMMALIAN CELL SYSTEMS
- Notice Date
- 2/13/2004
- Notice Type
- Sources Sought
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Bldg 427, Room 12, Frederick, MD, 21702
- ZIP Code
- 21702
- Solicitation Number
- S04-00
- Response Due
- 3/12/2004
- Archive Date
- 3/27/2004
- Point of Contact
- Deborah Vavreck, Contract Specialist, Phone (301) 846 - 5023, Fax (301) 846 - 5414,
- E-Mail Address
-
dvavreck@mail.ncifcrf.gov
- Description
- POC: Debra Vavreck, Supervisor Research Subcontracts, 301-228-4008 or e-mail dvavreck@ncifcrf.gov. DESC: The National Cancer Institute?s (NCI) Rapid Access To Intervention Development program (RAID) program is designed to utilize NCI contract resources to assist extramural investigators with the preclinical and clinical development requirements for drugs and biologics to be used in clinical trials. As part of this new initiative, the NCI wishes to identify qualified Offerors, who can provide clinical-grade production, purification, vialing, and release of recombinant proteins and monoclonal antibodies, using mammalian cell systems under current Good Manufacturing Practices (cGMPs) appropriate for Phase I/II clinical trials. The NCI will provide an accession cell bank containing the production system (hybridoma or CHO cell) of interest. The NCI will also provide a small amount (10-100mg) of laboratory grade purified protein for use as a preliminary reference standard, along with laboratory grade production and testing data. In addition, the NCI will provide information on the formulation and vialing requirements of all products. Offerors should have experience in the cGMP manufacturing and vialing of the cGMP manufacturing and vialing of clinical-grade recombinant proteins and monoclonal antibodies using mammalian cell systems (hybridoma or CHO cell), for clinical trials. The contractor will be required to provide a Certificate of Analysis (COA) that provides data to support the identity, composition, purity, potency, and safety of the requested products. In addition, the NCI should have the opportunity to cross-reference the contractors Drug Master File for IND purposes. Interested companies should describe their capabilities and experience and respond by March 12, 2004 to Debra Vavreck.
- Record
- SN00522370-W 20040215/040213212131 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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