Hoffmann-la Roche Inc.

F. Hoffmann-la Roche Ag

Markus Zadak

Kay-Gunnar Stubenrauch

Rudolf Vogel

Astrid Reiser

Mirko Ritter

Janis Brockhaus

The present invention relates to in vitro methods for determining the presence or absence of an anti-drug antibody (ADA) or drug/ADA immunecomplexes in a minipig sample. The invention further relates to antibodies specifically binding to minipig IgG that are applicable in the methods of the invention.

Method for determining anti-drug antibodies in a minipig sample

Herein is reported a method for the detection of a multispecific antibody in a sample, whereby the multispecific antibody is specifically bound by i) a first anti-idiotypic antibody binding to a first binding specificity of the multispecific antibody, and ii) by a second anti-idiotypic antibody binding to a second binding specificity of the multispecific antibody and the formed complex is determined.

Method for the detection of a multispecific binder

The current invention comprises a method for determining of an antibody against a drug antibody in a sample using an immunoassay comprising a capture drug antibody and a tracer drug antibody, wherein the method comprises providing i) a capture drug antibody, which is the drug antibody conjugated to a solid phase, ii) a tracer drug antibody, which is the drug antibody conjugated to a detectable label, contacting the capture drug antibody separately with i) the sample, ii) the sample, to which the drug antibody in monomeric form has been added, iii) the sample, to which the drug antibody in oligomeric form has been added, and determining an antibody against the drug antibody in the sample by a positive immunoassay in i) and a negative immunoassay in ii) and iii).

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Sindelsdorf, Germany

Markus Zadak