| 摘要 |
<P>PROBLEM TO BE SOLVED: To provide a means preliminarily easily estimating the safety of a chimera antibody, a hominization antibody or the like, or the treatment effect thereof by an in-vitro assay system in the prestage of a preclinical experiment in the development of an antibody drug. Ž<P>SOLUTION: This method for evaluating the risk of an antibody sample containing at least one of the human chimera antibody and the hominization antibody includes a reaction step of reacting the antibody sample with a heterophil antibody originating from a human being such as HAMA, HAChA or the like. As the heterophil antibody originating from the human being, HAMA positive serum or HAChA positive serum is utilized. In the reaction step, in the case where the antibody sample shows positivity with respect to the heterophil antibody originating from the human being, it is estimated that the antibody sample has a risk and, in the case where the antibody sample shows negativity with respect to the heterophil antibody originating from the human being, it is estimated that the antibody sample has no risk. Ž<P>COPYRIGHT: (C)2010,JPO&INPIT Ž
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