A Novel Total Drug Assay for Quantification of Anti-C5 Therapeutic Monoclonal Antibody in the Presence of Abundant Target

Aim: To mitigate assay interference in the drug and target assays to support the development of monoclonal antibody REGN-Z. Results: Mild acidic assay conditions and capture and detection antibodies with different affinities and t1/2 under different assay pHs were used to mitigate interference in the total drug and total target assays. A free target assay was also developed using a lower-affinity capture antibody with a much slower association and dissociation rate. The impact of sample incubation, dilution and storage on the accurate detection of the free target was also evaluated. Conclusion: The total drug, total and free target assays can accurately quantitate drug and target concentrations when tested with a subset of clinical study samples.

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A Novel Total Drug Assay for Quantification of Anti-C5 Therapeutic Monoclonal Antibody in the Presence of Abundant Target

Cited by 2 publications

References 34 publications

Overcoming Soluble Target Interference in Measurement of Total Bispecific Therapeutic Antibody Concentrations

Overcoming Soluble Target Interference in Measurement of Total Bispecific Therapeutic Antibody Concentrations

Assay pH and Critical Reagent Optimization in Measuring Concentrations of a Monoclonal Antibody and its Target

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