title: Evaluation of acoustic membrane microparticle (AMMP) technology for a sensitive ligand binding assay to support pharmacokinetic determinations of a biotherapeutic.
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.
authors.affiliation: Bioanalytical Sciences Biologics, Bristol-Myers Squibb, Princeton, New Jersey, USA, shannon.chilewski@bms.com.
authors.forename: Shannon D
authors.initials: SD
authors.lastname: Chilewski
authors.forename: W Matthew
authors.initials: WM
authors.lastname: Dickerson
authors.forename: Johanna R
authors.initials: JR
authors.lastname: Mora
authors.forename: Ashley
authors.initials: A
authors.lastname: Saab
authors.forename: Edward M
authors.initials: EM
authors.lastname: Alderman
mesh_terms: D000911:Antibodies, Monoclonal / Q000097:blood / Q000493:pharmacokinetics*; D015415:Biomarkers / Q000032:analysis; D015374:Biosensing Techniques / Q000295:instrumentation / Q000379:methods*; D006801:Humans; D007118:Immunoassay / Q000295:instrumentation / Q000379:methods*; D008024:Ligands; D057230:Limit of Detection; D008280:Magnetics; D008954:Models, Biological; D015203:Reproducibility of Results
chemical_list: D000911:Antibodies, Monoclonal; D015415:Biomarkers; D008024:Ligands