BioAgilytix Labs

BioAgilytix Labs

Founded out of four acquired bioanalytical laboratories, BioAgilytix Labs today operates as a pure-play CRO specializing in large-molecule bioanalysis. CEO Davide Molho, a veterinarian by training, leads a management team that includes scientific officers with PhDs and decades of assay development experience. The firm does not disclose its ownership structure or wealth origin, consistent with its role as a service provider rather than an investment vehicle. The firm provides pharmacokinetic (PK), immunogenicity, biomarker, and CMC analytical services in GxP environments, supporting every phase of drug development. Its client list includes 21 of the top 25 global pharmaceutical and biotechnology companies, as well as emerging biotechs and agricultural biotech firms (per the firm). BioAgilytix operates from laboratories in Durham, North Carolina; Hamburg, Germany; Boston, Massachusetts; San Diego, California; and Melbourne, Australia (via subsidiary 360biolabs). The company reported over 200 scientists and technical staff on its team page, and in 2025 was named Top Company for R&D Excellence by Triangle Business Journal. Its leadership includes 28 named executives spanning scientific, operational, and commercial roles. Adjacent entities include 360biolabs, an Australian subsidiary focused on preclinical and clinical bioanalysis. BioAgilytix differentiates through a scientist-to-scientist consulting model, where experienced scientists work directly with sponsor teams to proactively address assay challenges. The firm maintains full regulatory compliance with FDA, EMA, and other international agencies, and offers end-to-end program management across discovery, clinical development, and post-market surveillance — an uncommon breadth for a bioanalytical-only CRO.