Monoclonal antibodies: in vivo- and in vitro-production in laboratory scale with consideration of the legal aspects of animal protection.

Monoclonal antibodies are valuable tools in medical and biological research which can be used for identifying, characterizing and purifying medically and biologically important substances. Due to their high specificity monoclonal antibodies are more and more used in the diagnosis and therapy of infectious diseases and tumor illnesses. Large amounts of antibodies are needed for use in these areas and this necessitates mass production (g - kg range). Many production systems and possibilities for optimizing mass production have been described. In contrast, at universities and other research institutions the production of monoclonal antibodies in laboratory scale (mg range) is still carried out mostly in the ascites mouse. This article described our own experiences and results with the in vitro production in mg range. Using the German animal protection law (22.8.1986) as an example the legal aspects of animal protection in the production of monoclonal antibodies are discussed. In addition the legal regulations in Switzerland and the Netherlands are presented.