SOT 65th Annual Meeting & ToxExpo

At BioAgilytix, toxicology bioanalysis is built around one core principle: delivering high-quality, regulatory-ready data that enables confident decision-making during preclinical development. As programs advance toward the clinic, sponsors need a partner who understands both the scientific complexity of toxicology studies and the regulatory expectations that govern them.

BioAgilytix works in close collaboration with sponsors and their selected in-life study facilities to support non-GLP and GLP toxicology studies across a broad range of therapeutic modalities. Our teams apply validated methods, phase-appropriate strategies, and rigorous quality systems to ensure data integrity from study design through final reporting.

GLP toxicology studies are a critical component of preclinical development, designed to define the safety profile of investigative therapeutics and inform dose selection and IND-enabling decisions. With deep expertise across bioanalysis and CMC analytical services, BioAgilytix provides the scientific depth, operational scale, and reliability needed to support complex toxicology programs with confidence.

Toxicology Bioanalytical Support    
BioAgilytix routinely performs analysis of toxicology study samples across a wide range of endpoints, including:
•    Pharmacokinetics / Toxicokinetics (PK/TK)
•    Dose Formulation Analysis
•    Humoral Immunogenicity (ADA and Neutralizing Antibodies)
•    Cellular Immunogenicity (ELISpot and Flow Cytometry)
•    Biomarker Analysis
•    Multiplex Cytokine Panels
•    In Vitro DMPK
•    PK/TK Analysis and Regulatory-Ready Report