Accelerating Cell‑Based ADA Testing for mRNA Gene Replacement Therapy

Developing immunogenicity assays for complex biologic modalities can present unique analytical challenges. In this case study, a biotechnology sponsor partnered with Eurofins Viracor BioPharma to develop a cell-based anti-drug antibody (ADA) assay for an mRNA-based gene replacement therapy targeting a transmembrane protein.

Faced with assay variability, lengthy workflows, elevated background signal, and aggressive development timelines, Eurofins collaborated closely with the sponsor to redesign the assay approach. By transitioning from a continuous culture in-cell ELISA to a cellular lysate-based strategy, the team significantly improved sensitivity, reduced assay duration, minimized variability, and delivered a validated, regulatory-ready method.