Abstract
Background: Effective bioanalytical support for pharmacokinetic assessment of therapeutics in early development remains challenging. Concurrent evaluation of multiple candidates per program is typical, requiring efficient characterization in various preclinical species; an ambitious effort often complicated by assay reagent unavailability and limited sample volume. Accordingly, a universal anti-human Fc assay for human monoclonal antibody and derived therapeutics was developed using a microfluidics platform to address these bioanalytical challenges. Results: The universal assay with standardized format was qualified for quantitation of human IgG Fc-containing biotherapeutics in matrices from commonly used preclinical species. Results from this assay compared well with those from traditional colorimetric immunoassays. Furthermore, result comparison between the universal and target-specific assays provided additional information on the effect of antidrug antibodies and in vivo drug catabolism. Conclusion: This assay has wide applicability as a default bioanalytical approach in therapeutic candidate selection and preliminary pharmacokinetics evaluation during early-stage therapeutic development.
Due to copywrite restrictions, we are not allowed to offer the full article free-of-charge, however you can purchase the full article here.
Learn how BioAgilytix provides the
See how our PK expertise complements our immunogenicity services by evaluating
Learn why we’re a trusted partner to
What are your specific assay needs? Let’s schedule a conversation to review your
questions and requirements with one of our scientists.
Learn how BioAgilytix provides the
See how our PK expertise complements our immunogenicity services by evaluating
Learn why we’re a trusted partner to
What are your specific assay needs? Let’s schedule a conversation to review your
questions and requirements with one of our scientists.
Platforms
Services