Biosimilar Comparability

Biosimilar Comparability Studies

Biosimilars must show comparability to their originator biologic across multiple factors, including structure, function, and efficacy. Designing a cell-based assay to measure comparability requires an understanding of the underlying mechanism of action of the originator and the biosimilar. The data that are produced must be precise, accurate, and reproducible in order to satisfy regulatory requirements for comparability studies.

Cell-based assays are valuable at this stage as they provide multifaceted data that can inform downstream preclinical and clinical phases of development. The ZE5 Cell Analyzer supports this by enabling analysis of up to 30 parameters from a single sample, greatly expanding the number of biomarkers that can be monitored by a given cell-based assay. This is important when gathering data to provide as part of the totality of evidence required by regulatory agencies. The ZE5 Cell Analyzer is also well-suited for measuring rare or transient cell populations due to its fast analysis speed.

If a particular cell type is required for cell-based assays, then the bench top S3e Cell Sorter allows sorting of those populations without the need to schedule time at a core facility. The ZOE Fluorescent Cell Imager allows cells to be easily imaged at the bench, monitoring the health and activity of cells throughout the experiment.