NCI Frederick Cancer Research and Development Center (NCI-FCRDC), P.O. Box B, Frederick, Maryland 21702-1201

A -- CGMP PRODUCTION OF OLIGONUCLEOTIDES SOL S00-169 DUE 061300 POC Thomas L. Danver, Sr. Contract Specialist at 301-846-5422; Terry W. Hebb, Sr. Contracts Advisor at 301-846-5416 E-MAIL: Click here to contact the contract specialist via, tdanver@mail.ncifcrf.gov. The National Cancer Institute's (NCI) new 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 that will be used in clinical trials. As part of this new initiative, the NCI wishes to identify qualified Offerors, who can produce clinical-grade oligodeoxynucleotides in lengths up to 40 bases, using one or more backbones for use in clinical trials. As part of this new initiative, the NCI wishes to find new contract resources that are capable of manufacture, purification, formulation, and vialing of oligodeoxynucleotides under current Good Manufacturing Practices (cGMPs) appropriate for Phase I/II Clinical Trials. The NCI will provide the desired sequence and backbone structure. In addition, the NCI will provide information on the formulation and vialing requirements of all products. Offerors should have the cGMP manufacturing and vialing of clinical-grade oligodeoxynucleotides for clinical trials. The contractor will be required to provide a Certificate Of Analysis (COA), that provides data that support the identity, composition, purity, potency, and safety of the requested products. In addition, the NCI should have the opportunity to cross-reference the contractor=s Drug Master File for IND purposes. Interested companies should describe their capabilities and experience and respond by June 13, 2000 to Thomas L. Danver. Posted 05/26/00 (W-SN459383). (0147)

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