Abstract
Achieving the required sensitivity can be a challenge in the development of ligand binding assays for pharmacokinetic (PK) determinations of biotherapeutics. To address this need, BioScale’s Acoustic Membrane Microparticle (AMMP) technology was evaluated for the quantification of a PEGylated domain antibody (dAb) biotherapeutic. Previous uses of this technology had shown utility in biomarker and process development applications and this is the first application, to our knowledge, for PK determinations. In this evaluation, AMMP was capable of delivering a sensitivity of 0.750 ng/mL, which surpasses the sensitivity requirements for the majority of assays to support PK determinations. This evaluation demonstrates that this emerging technology has the ability to produce the required sensitivity, reproducibility, and selectivity needed to meet the industry’s standards for PK analysis.
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ACKNOWLEDGMENTS
The authors would like to acknowledge the work done by Murli Krishna and Holly Palmé in the oversight of reagent generation for this program. Steven Piccoli, Dharmesh Desai, Lora Hamuro, and Binodh DeSilva for review of this manuscript and Carol Gleason for statistical support.
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Guest Editors: Johanna Mora and Binodh Desilva
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Chilewski, S.D., Dickerson, W.M., Mora, J.R. et al. Evaluation of Acoustic Membrane Microparticle (AMMP) Technology for a Sensitive Ligand Binding Assay to Support Pharmacokinetic Determinations of a Biotherapeutic. AAPS J 16, 1366–1371 (2014). https://doi.org/10.1208/s12248-014-9659-7
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DOI: https://doi.org/10.1208/s12248-014-9659-7