Verfahren zur Herstellung von O-acetylsialylsäure-spezifischem Immunglobulin und Verfahren zur dessen Quantifizierung als Biomarker für akute lymphoblastische Leukämie

摘要

A process for preparing O-acetyl sialic acid specific immunoglobulin comprises: (i) separating serum from blood collected from patients with acute lymphoblastic leukemia; (ii) removing low molecular weight fractions and galactose binding proteins from the serum by affinity chromatography; (iii) passing the unbound galactose free protein fraction obtained in step (ii) over a different affinity matrix from that used in step (ii) to capture the O-acetyl sialic acid specific protein fraction; (iv) eluting the specific protein fraction with a buffer at alkaline pH followed by immediate neutralization of the fraction; and (v) purifying O-acetyl sialic acid specific immunogloulin protein from the fraction obtained in step (iv). A method of quantifying the amount of O-acetyl sialic acid specific immunoglobulin protein in the serum of patients suffering from acute lymphoblastic leukemia is also disclosed and comprises the claimed process in combination with an immuno detection assay.