Toxicology is the scientific discipline that studies the adverse effects of chemical, biological, or physical agents on living organisms, evaluating their mechanisms of toxicity, dose-response relationships, and safety thresholds. In biopharmaceutical development, preclinical toxicology studies — conducted in compliance with Good Laboratory Practice (GLP) guidelines — are required to characterize the safety profile of an investigational drug substance or drug product prior to first-in-human administration, and must be included in Investigational New Drug (IND) and Critical quality attributes (CTA) regulatory submissions. For CDMOs, providing GMP-manufactured material of defined quality and purity for toxicology studies is a critical early-phase service that bridges process development and clinical manufacturing.
