Market Development Manager, Animal Health Promega Madison, WI, United States
Abstract:
Background: The development of biologic drugs for veterinary oncology is increasingly important, requiring precise and reliable bioanalytical tools to ensure their efficacy and safety.
Objective: This study aimed to develop in vitro bioanalytical assays to support the characterization, potency assessment, and advancement of therapeutic targets in veterinary oncology.
Methods: This study utilized cellular and protein engineering approaches to develop two cell-based reporter bioassays— the Canine ADCC Reporter Bioassay and the Canine PD-1/PD-L1 Blockade Bioassay—along with Lumit® Immunoassays for Canine and Feline FcRn receptor binding. These luminescence-based assays were designed to measure target interactions with high sensitivity and specificity. Analytical performance characteristics, including accuracy, precision, linearity, and specificity, were rigorously assessed following International Council of Harmonization (ICH) guidelines.
Results: The cell-based bioassays demonstrated robust performance, accurately detecting and quantifying the potency of antibodies with high sensitivity and specificity. The Lumit® Immunoassays significantly reduced assay time to less than 70 minutes compared to traditional ELISAs, which require over 4 hours, while maintaining comparable accuracy. Conclusions and Clinical Importance: The advanced bioassays and immunoassays developed in this study provide a reliable, efficient, and comprehensive platform for the characterization and potency assessment of veterinary biologic drugs. By improving the sensitivity, specificity, and reproducibility of bioanalytical tools, these methods enable the development of more effective therapies. This supports advancements in veterinary oncology and better outcomes for companion animals.
