Innovative Instrument Supports BioAgilytix’s Characterization of Biomolecular Interactions and Monitoring and Characterization of ADAs from Preclinical to Clinical Development

Durham, NC—BioAgilytix, a leading global provider of contract bioanalytical testing services with specialization in large molecule bioanalysis, is continuing to expand capacity for immunogenicity studies in Europe with the implementation of an additional Biacore™ T200 platform in its Hamburg, Germany laboratory. This new platform will further enhance the ability of BioAgilytix’s European subsidiary, IPM Biotech, to characterize the biomolecular interactions of biotherapeutic candidates, and deliver highly specific analysis, robust data quality, and efficient time-to-results for immunogenicity studies at any phase of preclinical and clinical development. The new purchase represents the second T200 platform for the German lab, and the team has already had much success using this Biacore instrument to conduct investigations that are characterized by extreme kinetics, interacting partners with low molecular weights, and physiological concentrations that would be considered beyond the limits of detection for other platforms.

“We already have a great deal of experience leveraging the Biacore T200 platform for everything from defining potential drug targets and diagnostic markers to detecting and characterizing ADAs in immunogenicity studies,” said Dr. Arno Kromminga, Chief Scientific Officer, BioAgilytix Europe/IPM Biotech. “The beauty of the platform lies in its exceptional specificity, which enables us to evaluate molecular mechanisms and structure-function relationships with very high precision. We are excited to implement an additional Biacore in our lab to support new and larger safety and efficacy studies with highly accurate, highly reliable immunogenicity testing.”

The laboratory will primarily use the Biacore T200 platform for ADA characterization by isotyping and subclass identification; analysis for kinetics of receptor-ligand interaction; the measurement of monoclonal antibodies to CD16, CD32, CD64, and FcRn; and for anti-PEG antibody detection. “The versatility of the platform allows us to precisely characterize kinetics, affinity, specificity, concentration, and more,” added Kromminga. “Adding a second Biacore T200 to our portfolio further solidifies our position to effectively support global customers and their complex large molecule studies.”

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About BioAgilytix

BioAgilytix is a leading bioanalytical testing laboratory specializing in large molecule bioanalysis. With laboratory locations in North Carolina’s Research Triangle area and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of biologics across a number of industries and disease states. BioAgilytix offers assay development, validation, and sample analysis under non-GLP, spirit-of-GLP, GLP, and GCP, as well as product release testing under GMP.

BioAgilytix’s team of highly experienced scientific and QA professionals ensures high quality science, data integrity, and regulatory compliance through all phases of clinical development, and is a trusted partner to 23 of the top 25 global pharmaceutical and biotech companies. For more information, visit www.bioagilytix.com.