MONOCLONAL ANTIBODIES VERSUS SOLUBLE TNF-ALPHA RECEPTORS P55 AND P75 AND TNF-ALPHA AND ITS ANALOGUES

摘要

The submitted invention belongs to the field of pharmaceutical industry and refers to new monoclonal antibodies and their fragments which bind to an accessible surface of human recombinant TNF-Alpha, TNF-Alpha analogues and TNF-Alpha soluble receptors. The invention also refers to stable cell lines of hybridomas which are capable of producing such monoclonal antibodies, to the procedure for their preparation and to pharmaceutical preparations which contain them. Further, the invention refers to the method for a quantitative determination of a human TNF-Alpha, free and complex with soluble TNF-Alpha receptors p55 and p75 as well as putty which is used in this procedure. It was not possible to simultaneously determine free TNF-Alpha macromolecules and their soluble receptors as well as their complexes by means of monoclonal antibodies known so far and the reagents developed from them. This invention also refers to TNF-Alpha analogue TNF-Alpha His 107/108, Cys95/148 which is used in the complex with TNF-Alpha receptors as an antigen for the immunization of mice.