Discover how an innovative assay design improved immunogenicity testing for an mRNA gene replacement therapy.

Developing reliable anti-drug antibody (ADA) assays for advanced therapies can present unique analytical challenges. This case study highlights how a novel cellular lysate-based approach improved the performance of a cell-based ADA assay, reducing complexity while increasing sensitivity, reproducibility, and testing efficiency to support clinical development.

Key highlights include:

• Development and validation of a novel cellular lysate-based ADA assay for an mRNA gene replacement therapy
• Reduction of assay duration from three days to one day, enabling higher throughput and faster data delivery
• Improved assay sensitivity to 360 ng/mL, exceeding regulatory expectations for immunogenicity testing
• Elimination of continuous cell culture, reducing assay variability and operational complexity
• Use of a ratio-based response with induced and non-induced cells to improve assay specificity
• Delivery of a regulatory-ready validated method that supported timely clinical decision-making

This case study demonstrates how innovative assay design, scientific collaboration, and bioanalytical expertise can help sponsors overcome complex immunogenicity challenges and accelerate the development of advanced gene therapies.