VERFAHREN ZUM PASTEURISIEREN VON PLASMAPROTEIN UND PLASMAPROTEINFRAKTIONEN

Process for the preparation of an immunoglobulin which is stable in liquid form for intravenous administration

The invention relates to a process for the preparation of an immunoglobulin which is free of side effects and stable on storage in liquid form for intravenous administration with a monomer content of more than 97%, in which euglobulins and other impurities are removed from a prepurified immunoglobulin solution by precipitation and adsorption onto an ion exchanger, the immunoglobulin, which has been stabilized where appropriate by acid and heat treatment, is further purified by repeated ion exchange treatment, and aggregated proteins are removed by precipitation with low molecular weight PEG, and subsequently the PEG is removed. The solution is preferably converted into a form suitable for administration by ultra- or diafiltration.

Method for pasteurizing proteins of plasma and protein fractions of plasma

The invention relates to a process for the pasteurization of plasma proteins and plasma protein fractions without essentially impairing their biological activity, by subjecting a suspension of the plasma proteins or plasma protein fractions in glycerol esters of saturated or singly or multiply unsaturated fatty acids having 4-22 carbon atoms, or mixtures of these esters, as the inert heat-transfer agent, with a maximum water content of the suspension of 1% by weight, to a heat treatment at temperatures of 50 DEG to 120 DEG C.

Verfahren zum pasteurisieren von plasmaproteinen und plasmaproteinfraktionen.

Procedimiento para el pasteurizado de plasmaproteinas y de fracciones de plasmaproteinas.

LA INVENCION SE REFIERE A UN METODO PARA PASTEURIZAR PLASMA PROTEINAS Y FRACCIONES DE PLASMA PROTEINAS SIN PERJUDICAR ESENCIALMENTE SU ACTIVIDAD BIOLOGICA SOMETIENDO UNA SUSPENSION DE LAS PLASMA PROTEINAS O DE LAS FRACCIONES DE LA MISMA EN ESTEROS DE GLICERINA DE ACIDOS GRASOS SATURADOS CON 4-22 ATOMOS DE CARBON O MEZCLAS DE ESTOS ESTEROS COMO TRANSMISORES INERTES DE CALOR CON UN CONTENIDO MAXIMO DE AGUA DE 1% (PESO) A UN TRATAMIENTO DE CALOR CON TERMPERATURAS ENTRE 50 Y 120 C.