The contractor shall produce upon receipt of a given hybridoma provided by the NCI, 10 to 50 grams of a given monoclonal antibody. The Project Officer will determine the gram amounts of monoclonal antibody to be produced based on the amount needed for specific Phase I/II clinical trials. The contractor will be expected to have the requisite capability to produce a monoclonal antibody by currently available cell culture techniques. The contractor shall purify the monoclonal antibody by filtration and currently available salt fractionation and ion exchange chromatography procedures to provide a product that is 95% or more pure by HPLC analysis. The contractor shall characterize each monoclonal antibody according to isotype, total protein and specific immunoglobulin concentration, HPLC, SDS-PAGE, and specific antigen binding. The contractor shall test monoclonal antibody preparations as appropriate at the hybridoma, ascites or pure stage for sterility, endotoxin, mycoplasma, MAP test for virus, LCM and REO-3 virus, DNA detection, rabbit pyrogen, general safety, and potency as required by the FDA and outlined in current guidelines of the Office of Biologics, FDA, for monoclonal antibody. The contractor shall carry out vialing and labeling of purified pharmaceutical grade monoclonal antibody in compliance with FDA specifications, and store in a stable form pending release for clinical trial upon request by the Project Officer.
