Implementation of a universal analytical method in early-stage development of human antibody therapeutics: application to pharmacokinetic assessment for candidate selection

摘要: Background: Effective bioanalytical support for pharmacokinetic assessment of therapeutics in early development remains challenging. Concurrent evaluation multiple candidates per program is typical, requiring efficient characterization various preclinical species; an ambitious effort often complicated by assay reagent unavailability and limited sample volume. Accordingly, a universal anti-human Fc human monoclonal antibody derived was developed using microfluidics platform to address these challenges. Results: The with standardized format qualified quantitation IgG Fc-containing biotherapeutics matrices from commonly used species. Results this compared well those traditional colorimetric immunoassays. Furthermore, result comparison between the target-specific assays provided additional information on effect antidrug antibodies vivo drug catabolism. Conclusion: T...