Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
8417603 | Journal of Immunological Methods | 2015 | 13 Pages |
Abstract
Results from this study indicate the presence of IC during administration of an immunogenic biotherapeutic. Potential application of these assays includes detection of ADA in an IC during high drug levels. The results on the kinetics of IC formation during ADA response can complement the understanding of PK and ADA profiles. Moreover, the presence of IC indicates possible ADA interference in standard PK assays and potential underestimation of total drug exposure in toxicology studies. In addition this study also highlights the need to understand downstream in vivo consequences of drug-ADA IC as no animals under investigation developed adverse events.
Keywords
PBSNQCLQCFc-gamma receptorMRDFcγRHQCCREAMSDALTHRPmAbSECBSAligand binding assayImmunoassaysASTAspartate aminotransferaseAlanine aminotransferasebovine serum albuminAnti-drug antibodyanti-drug antibodiesImmunogenicityUltra violetBUNpharmacokineticLBAMALSimmune compleximmune complexescut pointblood urea nitrogenADAMonoclonal antibodiesHorseradish peroxidasemulti-angle light scatteringcreatinineSize exclusion chromatographyHigh pressure liquid chromatographyHPLCMeso Scale Discoveryquality control
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Authors
Piotr Pierog, Murli Krishna, Aaron Yamniuk, Anil Chauhan, Binodh DeSilva,