Implementation of a universal analytical method in early-stage development of human antibody therapeutics: application to pharmacokinetic assessment for candidate selection
2012
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
assayreagent unavailability and limited sample volume. Accordingly, a universal anti-human Fc
assayfor human monoclonal antibody and derived therapeutics was developed using a microfluidics platform to address these bioanalytical challenges. Results: The universal
assaywith standardized format was qualified for quantitation of human IgG Fc-containing biotherapeutics in matrices from commonly used preclinical species. Results from this
assaycompared well with those from traditional colorimetric immunoassays. Furthermore, result comparison between the universal and target-specific
assaysprovided additional information on the effect of antidrug antibodies and in vivo drug catabolism. Conclusion: T...
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