Invention Grant
- Patent Title: Method for the determination of anti-drug antibodies against an effector function suppressed human or humanized drug antibody
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Application No.: US15587730Application Date: 2017-05-05
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Publication No.: US11340234B2Publication Date: 2022-05-24
- Inventor: Pablo Umana , Uwe Wessels , Kay-Gunnar Stubenrauch
- Applicant: Hoffmann-La Roche Inc.
- Applicant Address: US NJ Little Falls
- Assignee: Hoffmann-La Roche Inc.
- Current Assignee: Hoffmann-La Roche Inc.
- Current Assignee Address: US NJ Little Falls
- Agent Jonathan P. Aumais
- Priority: EP14191806 20141105
- Main IPC: G01N31/00
- IPC: G01N31/00 ; G01N33/53 ; G01N33/68 ; G01N33/50

Abstract:
Herein is reported an anti-drug antibody immunoassay for the determination of the presence of an anti-drug antibody against an effector function suppressed human or humanized drug antibody in a sample comprising the incubation of a sample comprising mammalian blood serum with full length human Fcgamma receptor I or an Fc-region binding fragment thereof so that a complex between the anti-drug antibody against the effector function suppressed human or humanized drug antibody present in the sample and the human Fcgamma receptor I or the Fc-region binding fragment thereof forms, whereby the full length human Fcgamma receptor I or the Fc-region binding fragment thereof is conjugated to a detectable label, and the determination of the formed complex by the detectable label.
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