Monoclonal Antibodies: In Vivo and In Vitro Production on a Laboratory Scale, with Consideration of the Legal Aspects of Animal Protection

Abstract

Antibodies in the serum of immunised animals are polyclonal. That is, they react with all determinants of an antigen. Monoclonal antibodies, however, are produced by cells which are all derived from a single antibody-producing cell; hence they are highly specific and react with only one antigenic determinant. Monoclonal antibodies are valuable tools in medical and biological research and can be used for identifying, characterising and purifying medically and biologically important substances. Due to their high specificity, monoclonal antibodies are increasingly used in the diagnosis of infectious disease and neoplasia. Large amounts of antibodies are needed for use in these areas and this necessitates mass production (in the g–kg range); so many authors have described production systems and possibilities for optimising mass production. In contrast, at universities and other research institutions, the production of monoclonal antibodies on a laboratory scale (in the mg range) is still carried out, mostly in the ascites mouse. Certain research areas, require only {minimum amounts μg range) of monoclonal antibodies, so maximising production of antibodies is unnecessary, and as a rule, the yield of a stationary cell culture will suffice. This article summarises the in vivo and in vitro methods described up to now, as well as our own experiences and results. Taking the German animal protection law (22.8.86) as a basis, 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 considered.