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

A -- CGMP PRODUCTION OF RECOMBINANT HERPES SIMPLEX VIRUS CONSTRUCTS SOL S00-168 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 Herpes Simplex Virus (HSV) constructs for use in vaccine 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 Herpes constructs under current Good Manufacturing Practices (cGMPs) appropriate for phase I/II clinical trials. The NCI will provide the recombinant Herpes Simplex 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 Herpes Simplex virus and/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 June 13, 2000 to Thomas L. Danver. Posted 05/26/00 (W-SN459382). (0147)

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