N-glycan Analysis in Mammalian Cell Productionprocesses: Evaluation, Validation and Application of a High Sensitive Analytical Standard Scheme

Dr. Stefan Zietze is Quality Control Manager at ProBioGen, Berlin, Germany. Hisresponsibilities include the management of a QC-laboratory and the assistant directorfunction for the QC/QA unit at ProBioGen. Stefan studied Pharmacy at the Humboldt-University in Berlin, Germany, where hereceived his M. Sc. in 2002. In 2003 he passed the examination as registeredpharmacist. From 2003 - 2006 he worked on his PhD-thesis with the title Evaluation, validation and application of an analytical scheme for N-glycosylation analysis usedfor mammalian cell production processes as an external PhD-student in the QC/QAunit of ProBioGen, supervised by the Free University of Berlin. Besides his expertisein the quality control of glycoproteins, he is also responsible for transferring analyticalmethods, stability testing and formulation studies as well as the design ofexperiments by sophisticated statistical methods (DoE).