Krakow Clinical Trials Forum
1st Krakow Clinical Trials Forum 2026 | July 11-12, 2026 | Krakow (POL)
Mabion will join the 1st Krakow Clinical Research Forum, where Beata Talar, Bioanalytical Methods Manager, will present the poster “Improvement of Pharmacokinetic Assessment in Biosimilar Clinical Trials: Transition from Gold Standard ELISA to Gyrolab xPlore“.
The poster presents Mabion’s practical experience in optimizing pharmacokinetic assessment for biosimilar development. Within the MabionCD20 program, Mabion first developed and validated a GLP-compliant ELISA method for PK analysis in the Phase III MABRA study. The method met EMA and FDA expectations for PK studies and was accepted during regulatory evaluation. To increase analytical performance and laboratory throughput in the Phase III MADILYM study, the assay was subsequently transferred to the automated Gyrolab xPlore platform.
This transition reflects a broader trend in regulated bioanalytics: the need for methods that combine sensitivity, reproducibility, robustness, and operational efficiency. The Gyrolab-based assay demonstrated high precision and accuracy across the validated range of 5–500 ng/mL and showed robustness in challenging sample conditions, including hemolytic and lipemic matrices. More than 2,600 clinical PK samples were analyzed during the MADILYM clinical trials, with 99% of incurred sample reanalysis results meeting acceptance criteria.
Mabion Showcases Advanced Bioanalytics for Clinical Trials
Mabion applies this experience across a wider offering in PK, PD, and immunogenicity analytics for biologic drug development.
- In Pharmacokinetics, Mabion supports the evaluation of monoclonal antibodies and other biologics in preclinical and Phase I–III clinical studies using high-throughput Gyrolab xPlore and ELISA-based platforms.
- In Pharmacodynamics, Mabion develops methods using flow cytometry and immunoassay platforms to assess drug effects on circulating cell populations and soluble protein targets, with applications in both biologic and non-biologic therapeutic programs.
- In Immunogenicity, Mabion provides end-to-end ADA testing, including screening, confirmatory, and titer assays, followed by neutralizing antibody assessment using competitive ligand-binding and cell-based formats, including ADCC reporter assays.
By combining scientific expertise, dedicated facility, automated platforms, and experience from biosimilar clinical development, Mabion is well positioned to support sponsors and CROs seeking reliable bioanalytical partners. The company is open to collaboration in method development, transfer, validation, and execution from standalone analytical services to broader co-development models.
Learn more about the Clinical Trials Forum on the website.