Addressing drug effects on cut point determination for an anti-drug antibody assay

Barbosa, Maria D.F.S.; Gleason, Carol; Phillips, Kelli; Berisha, Flora; Stouffer, Bruce; Warrack, Bethanne M.; Chen, Guodong

doi:10.1016/j.jim.2012.06.014

Journal of Immunological Methods

2012

DOI: 10.1016/j.jim.2012.06.014

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Addressing drug effects on cut point determination for an anti-drug antibody assay

Maria D.F.S. Barbosa

Carol Gleason

Kelli Phillips

et al.

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Cited by 4 publications

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Practical Considerations for the Pharmacokinetic and Immunogenic Assessment of Antibody–Drug Conjugates

Sauerborn¹,

Dongen²

2014

BioDrugs

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Currently, the most bioanalytically challenging drugs are antibody-drug conjugates (ADCs), constructs comprising a monoclonal antibody and a cytotoxic drug connected by a linker. The bioanalytical challenges arise from the heterogeneous nature of ADCs and their complex in vivo behavior, resulting in a high number of analytes to be measured. Measuring the concentration of biologics in blood/plasma/serum is a necessity to properly assess their pharmacokinetic (PK)/pharmacodynamic behaviors in vivo. An additional bioanalytical challenge is to monitor the stability of the ADCs, as cytotoxic drugs released from the ADC in blood circulation may pose a potential safety risk because of their high cytotoxic potency. The nature of ADCs does not only complicate bioanalysis, but also immunogenicity assessment. Questions, such as 'Which part of the ADCs is the anti-drug antibodies directed against?' may arise, and their answer normally includes several immunogenicity risk assessment strategies. This review will focus on the bioanalytical challenges of ADCs, current approaches involving ligand-binding assays (LBAs), liquid chromatography and mass spectrometry platforms, and recommendations on which approach to use for which stage of drug development, and will close with immunogenicity assessment. In order to appropriately tackle the bioanalytical and immunogenic challenges of ADCs and consider every angle, the authors of this review have expertise in ligand binding and liquid chromatography-mass spectrometry.

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Practical Considerations for the Pharmacokinetic and Immunogenic Assessment of Antibody–Drug Conjugates

Sauerborn¹,

Dongen²

2014

BioDrugs

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show abstract

Channeling postmarketing patient data into pharmaceutical regulatory systems

Barbosa¹,

Smith

2014

Drug Discovery Today

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Immunogenicity Considerations for Antibody–drug Conjugates: A Focus on Neutralizing Antibody Assays

Fiorotti¹

2017

Bioanalysis

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Addressing drug effects on cut point determination for an anti-drug antibody assay

Cited by 4 publications

References 7 publications

Practical Considerations for the Pharmacokinetic and Immunogenic Assessment of Antibody–Drug Conjugates

Practical Considerations for the Pharmacokinetic and Immunogenic Assessment of Antibody–Drug Conjugates

Channeling postmarketing patient data into pharmaceutical regulatory systems

Immunogenicity Considerations for Antibody–drug Conjugates: A Focus on Neutralizing Antibody Assays

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