Frank Merkle

• Planning and performance of analytical experiments in a GMP environment for release and stability studies • Optimization and validation of bioanalytical test methods, e.g. cell-based potency assays, ELISA, SDS-PAGE and western blot • Documentation of analytical results according to cGMP • Address and provide input for unexpected results and deviations • Participate in inspections from health authorities, e.g. FDA • Evaluation, qualification and periodic functional testing of analytical instruments

• 6month working exchange in process development (upstream) in Menges (Slovenia) • Preparing of inoculum in shake flasks • Analysis of metabolites, cell viability, pH and osmolality • Working with fed-batch bioreactors (up to 5L) and harvesting of cell culture with filtration • Interpretation of results with Excel and Design of Experiments (DoE) • Participation in a process characterization (Scale Down Model)

• Production and purification of His tag proteins • Determination of protein concentration • Protein separation techniques

Molekulare Bioanalytik