作者: Shannon D Chilewski , Johanna R Mora , Carol Gleason , Binodh DeSilva
DOI: 10.4155/BIO.14.75
关键词:
摘要: Background: Ligand-binding assays (LBAs) used in the quantification of biotherapeutics for pharmacokinetic determinations rely on interactions between reagents (antibodies or target molecule) and biotherapeutic. Most LBAs do not employ an analyte extraction procedure are susceptible to matrix interference. Here, we present a case study development LBA PEGylated domain antibody where interference was observed. The assay support single ascending dose plate-based electrochemiluminescent with lower limit 80 ng/mL. To meet sensitivity requirements future studies, new Gyrolab™ Workstation were evaluated. Results: Assay improved nearly threefold final method utilizing reagents, buffer containing blockers human anti-animal antibodies, Gyrolab Workstation. Conclusion: Experimental data indicate that all factors changed played role overcomi...