Mass Production of Monoclonal Antibodies

The production of large amounts of monoclonal antibodies (MAB) (Fig. 25) has increased in importance proportionately as these are used increasingly in human and veterinary medical diagnostics, in agriculture and also, finally, in therapeutic procedures in humans. No longer are only a few micro- or milligrams required for analytical purposes, but rather gram or even sometimes kilogram amounts are required. To produce such amounts as ascites fluid can scarcely be answered for on ethical grounds, and so nowadays, fortunately, large amounts of MAB are produced essentially entirely in vitro, i.e., in bioreactors (Kuhlmann et al. 1989). A variety of additional practical reasons also speak for in vitro production: 1. The use of cell culture supernates is always necessary if antibodies produced in the body of a mouse (ascites) would be a disturbing factor. A pure monoclonal antibody can be obtained practically only from serum-free culture. 2. An important advantage of serum-free cell culture is that the antibodies can be purified relatively simply. 3. The more an in vitro reactor system resembles the extremely efficient “bioreactor mouse” in physiological and physiochemical respects, the higher its efficiency, which is synonymous with high quantity, high quality and economical MAB production. Meanwhile, the bioreactor systems available show significant advantages over the bioreactor mouse in respect of reproducability, scale-up, surveillance, and control.