eChalk Talk: Risk Mitigation in Bioanalysis to Maintain the Integrity of Drug Development Studies

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Description

It is critical to prioritize safety in drug development studies. The bioanalysis data plays a vital role in the decisions taken during the development process and it is crucial to ensure that the results obtained are reliable. Therefore, prioritizing risk mitigation in bioanalysis is essential to maintain the integrity of drug development studies.

Ligand binding assays (LBA) are widely used to quantify biopharmaceuticals and biomarkers, as well as to evaluate immunogenicity in preclinical and clinical studies. In this presentation, we will highlight key factors to keep in mind when developing a ligand binding assay. The focus will be on creating a robust assay with high specificity and selectivity. We will show real-life common challenges through case studies and suggest solutions based on our extensive experience in developing ligand binding assays.

Contributors

Tanja Jarhede, Ph.D.

Tanja Jarhede holds a Ph.D. in biochemistry and more than 20 years of experience in developing fit-for-purpose ligand binding assays for bioanalysis (PK, biomarker, and immunogenicity assays). In her current role, she brings both scientific and technical knowledge to customers and internal assay development projects. Before joining Mercodia she worked as a Scientist at Biacore which gave her knowledge about binding kinetics and reagent characterization.

Tanja also has extensive expertise in assay validation, including a thorough understanding of the regulatory guidelines from the FDA, EMA, ICH, and the Points to Consider document for biomarkers from C-path.

Thank you

Description

Contributors

Tanja Jarhede, Ph.D.