AGI provides comprehensive bioanalytical assay development and validation services to ensure reliable, reproducible data across the preclinical pipeline. Our expertise spans pharmacokinetic, pharmacodynamic, and immunogenicity assay platforms, with capabilities ranging from ligand-binding and cell-based assays to molecular and biomarker-driven approaches. Each assay is designed to meet rigorous regulatory expectations, including FDA and EMA guidance, and undergoes full validation to confirm specificity, sensitivity, accuracy, precision, and stability. By leveraging high-resolution analytical technologies and strict quality control systems, we deliver data that withstands regulatory scrutiny and supports seamless progression from discovery through IND-enabling studies.

 

Our scientists collaborate closely with sponsors to tailor assays to the unique properties of each candidate therapy, accommodating complex modalities such as gene therapies, biologics, and advanced delivery systems. This adaptability ensures that analytical methods remain relevant across study phases and therapeutic areas, reducing risk and enhancing translational predictability. With GLP-capable facilities, rapid turnaround times, and a proven record of regulatory compliance, AGI provides sponsors with a dependable foundation for decision-making, regulatory submissions, and clinical advancement.