公开(公告)号：EP2823310A1

公开(公告)日：2015-01-14

申请号：EP13707879.6

申请日：2013-03-07

申请人： F.Hoffmann-La Roche AG

发明人： DAHL, Uwe ,  JORDAN, Gregor ,  STAACK, Roland

IPC分类号： G01N33/564 ,  G01N33/68 ,  G01N33/94

CPC分类号： G01N33/564 ,  G01N33/686 ,  G01N33/94

摘要： Thus, herein is reported a method for analyzing/characterizing circulating immune complexes (CICs) formed in vivo comprising a size-exclusion chromatography of a sample obtained from a mammal to which the drug had been administered at least once for determining the weight/size of the immune complexes, optionally a second non-SEC chromatography, and at least one immunoassay, whereby the immune complex is characterized by the correlation of the immune complex size and the immunoassay result/read-out. Also reported herein is the use of a method as reported herein for determining a correlation to altered pharmacokinetics, for determining loss or reduction of efficacy, for determining neutralization of natural counterparts of the drug, for determining immune and hypersensitivity reactions, including serum sickness/type III hypersensitivity reaction/immune complex-mediated disease.

摘要翻译： 因此，本文报道了用于分析/表征在体内形成的循环免疫复合物（CIC）的方法，其包括从已经给予该药物至少一次的哺乳动物获得的样品的尺寸排阻色谱以确定重量/尺寸 免疫复合物，任选的第二非SEC色谱法和至少一种免疫测定法，其中免疫复合物的特征在于免疫复合物大小与免疫测定结果/读数的相关性。 本文还报道了使用本文报道的用于确定与改变的药代动力学相关性的方法的用途，用于确定药物的天然对应物的中和，用于确定药物的天然对应物的中和，用于确定免疫和超敏反应，包括血清病/类型 III超敏反应/免疫复合物介导的疾病。

公开(公告)号：EP2883051A1

公开(公告)日：2015-06-17

申请号：EP13745066.4

申请日：2013-08-02

申请人： F.Hoffmann-La Roche AG

发明人： DAHL, Uwe ,  JORDAN, Gregor ,  STAACK, Roland

IPC分类号： G01N33/557

CPC分类号： G01N33/557 ,  G01N33/15

摘要： Herein is reported a method for the determination of the binding affinity of a binder and its ligand comprising the step of determining based on the result of an immunoassay the fraction of free binder in a sample comprising binder, ligand and binder-ligand -complexes for at least two different binder:ligand ratios in the sample, and if the determined fraction of free binder is not comparable for all used binder:ligand ratios then the binder:ligand ratio in the sample is lowered and the sample is re-analyzed by the same immunoassay, and calculating based on the fraction of free binder in the previous step the binding affinity for the binder to its ligand.

摘要翻译： 本文报道了用于确定粘合剂及其配体的结合亲和力的方法，包括基于免疫测定结果确定包含粘合剂，配体和粘合剂 - 配体 - 络合物的样品中的游离粘合剂部分的步骤的步骤 样品中至少两种不同的粘合剂：配体比例，如果确定的游离粘合剂的分数与所有使用的粘合剂：配体比例不相称，则样品中的粘合剂：配体比例降低，并且样品重新分析 免疫测定，并且基于前一步骤中游离粘合剂的分数来计算粘合剂对其配体的结合亲和力。