Choose Your Format: Clinical Antibodies Without Cold Storage

Presented by: Christian Schmitz, Evidentic Poster Number: P-203-Th Poster Session: Characterizing, Bridging and Improving Bioassays Thursday, 25 Sept. at 10:30 ----- Background: High-quality reference standards are essential for reliable biotherapeutic characterization. Evidentic provides dual-format clinical-grade reference materials— established frozen liquid standards and innovative lyophilized standards—offering flexible solutions for analytical needs. Lyophilized formats deliver extended stability, simplified logistics, and global accessibility. Methods: Cetuximab (Erbitux®), a therapeutically licensed EGFR-targe ng monoclonal antibody, was analyzed in liquid and lyophilized formats. Quality assays included size exclusion chromatography (SEC) for aggregation assessment, turbidity measurements, nanoDSF/DLS for conformational stability, and bioactivity evaluation via reporter gene assays. Results: This study represents the first availability of clinical-grade Cetuximab in lyophilized format for research applications, expanding beyond traditionally available liquid formats. Both formats demonstrated analytical robustness and retained full bioactivity profiles. SEC analysis confirmed preserved monomer integrity. NanoDSF revealed that sucrose-spiked lyophilized Cetuximab maintained conformational stability equivalent to liquid counterparts. Bioactivity assays showed identical functional performance within method variability. Conclusions: We have demonstrated that lyophilized reference standards are analytically equivalent to frozen liquid standards, introducing an innovative format of clinical therapeutic antibodies. Both formats serve as reliable reference products for bioassay validation, empowering quality control, comparability studies, and analytical method validation across biotherapeutic applications.