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

A -- GMP PRODUCTION OF VACCINIA CONSTRUCTS SOL S00-137 DUE 032400 POC Angela Keenan, Sr. Contract Specialist, 301-846-1444 WEB: Click here for further information about the NCI-FCDRC, http://web.ncifcrf.gov. E-MAIL: Click here to contact the Contract Specialist, akeenan@mail.ncifcrf.gov. The National Cancer Institute's (NCI) new Rapid Access To Intervention Development(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 vaccinia constructs for use in vaccine trials. As part of this initiative, the NCI wishes to find new contract resources that are capable of manufacture, formulation, and vialing of vaccinia constructs under current Good Manufacturing Procedures (cGMP) appropriate for Phase I/II clinical trials. The NCI will provide the Wyeth strain vaccinia recombination vector containing the DNA sequence of interest. 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 clinical-grade vacciniaand/or viral products for clinical trials. The contractor will be required to provide a Certificate Of Analysis (COA), which 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 March 24, 2000 to Angela Keenan. Posted 03/03/00 (W-SN431005). (0063)

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