National Cancer Institute, Research Contracts Branch, Executive Plaza South, Room 603, Bethesda, MD 20892

A -- PRODUCTION, PROCESSING AND QUALITY ASSURANCE TESTING OF BIOLOGICAL RESPONSE MODIFIERS SOL RFP-NCI-CM-67241-75 DUE 081595 POC BERNICE EVANS BELT, CONTRACT SPECIALIST, 301-496-8620 DOROTHY M. COLEMAN, CONTRACTING OFFICER, 301-496-8620. The Biological Response Modifiers Program (BRMP) of the National Cancer Institute (NCI) has the responsibility for preclinical and early clinical evaluation and development of a wide variety of Biological Response Modifiers (BRMs) with potential for cancer therapy. An important aspect of this responsibility is the procurement, processing and quality assurance testing of various BRMs for preclinical and clinical investigations. The purpose of the present solicitation is to provide support to the NCI in the following areas: 1) production, purification and vialing of murine monoclonal antibodies (MoAb) produced under GLP and GMP conditions; 2) production, purification and vialing of MoAb immunoconjugates under GLP and GMP conditions; 3) production, purification and vialing of protein/peptide vaccines under GLP and GMP conditions, 4) purification, vialing and purity testing of BRMs received in bulk form; 5) assay preparations of BRMs for microbial agents to conform to FDA specifications pertaining to the testing of biological (21 CFR 610.11 and 21 CFR 610.12); 6) organize available manufacturing information into a form suitable for use in an Investigational New Drug (IND) applications. RFP-NCI-CM-67241-75 will be issued on or about July 07, 1995. The Government anticipates (1) level- of-effort contract will be awarded on an incrementally funded basis for a period of five years. The Standard Industrial Classification (SIC) code is 8731. No collect calls will be accepted. (0164)

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