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Title:
抗原または抗抗体が結合したモノクローナル抗体の定量方法
Document Type and Number:
Japanese Patent JP6984657
Kind Code:
B2
Abstract:
The present invention provides a method in which a porous body having a monoclonal antibody to be measured immobilized in pores thereof is brought into contact with nanoparticles having a protease immobilized thereonto in a liquid to perform selective protease digestion of the monoclonal antibody and a peptide fragment obtained by the digestion is detected by liquid chromatography mass spectrometry (LC-MS), wherein the monoclonal antibody is digested with the protease in the presence of an antibody specifically binding to the monoclonal antibody or a target molecule of the monoclonal antibody.

Inventors:
Noriko Iwamoto
Takashi Shimada
Application Number:
JP2019524799A
Publication Date:
December 22, 2021
Filing Date:
June 22, 2017
Export Citation:
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Assignee:
SHIMADZU CORPORATION
International Classes:
G01N27/62; G01N33/68
Foreign References:
WO2016143224A1
Other References:
Noriko Iwamoto,Development of LCMS-Based Fully Validated Bioanalysis of CDR Peptides in Antibody Drugs by Fab-Selec,2016 AAPS ANNUAL MEETING AND EXPOSITION Poster,2016年11月16日
Matthew Baker,Immunogenicity of protein therapeutics: The key causes, consequences and challenges,Self/Nonself,2010年12月01日,Vol.1/Iss.4,PP.314-322
厚生労働省医薬食品局,バイオテクノロジー応用医薬品の非臨床における安全性評価,2012年03月23日,PP.1-23
佐々木毅,自己抗体イディオタイプと臨床,臨床病理,日本,1994年,42巻9号,PP.925-928
Attorney, Agent or Firm:
Hiraki International Patent Office