Cell line generation and in-vitro potency assay development for r-hLH market batch release

The thesis describes the development of an in-vitro potency bioassay for r-hLH samples appliedbefore batch release on the market, with the final aim to replace the current applied in-vivo method.For this purpose, the cell line to be used in the assay has been generated in-house throughtransfection processes. The generated cell line expressed the target of interest and produced aquantifiable signal, resulting suitable for its application. A characterization study has beenperformed on generated cell line studying study cells’ behavior, monitoring different parametersover time. The characterization study is considered a fundamental step in order to deeplyunderstand cell line behavior in a determined period of time, the generated documentation of thestudy will support the future quality control routine application of the cells and will support also theproposal submission of the in-vivo method replacement to health authorities. The in vitro potencyassay has been successfully developed beside the cell line generation and characterization.