Monoclonal antibodies, due to their unique specificity and high affinity for the epitopes they bind, have found numerous applications in basic and clinical research. Their use in anti-neoplastic therapeutic regimes, anti-inflammatory protocols, and septic shock treatment is gaining momentum. Since industrial scale production of monoclonal antibodies from hybridomas involves substantial capital investment and production of recombinant antibodies in E. coli has certain limitation with respect to stability, yield, or applicability, the plan, in Phase I, is to adapt an existing baculovirus expression system for the efficient secretion (100- 150 mg/liter) of functional antibodies. In Phase II, the plan is to use this system for the large scale production of a recombinant monoclonal antibody directed against HER-2/neu, a human epidermal growth factor (EGF) receptor that is overexpressed in breast and ovarian cancers. Such a monoclonal antibody has shown promising results in clinical trials.
