During the development of a therapeutic recombinant monoclonal antibody, the forced degradation is one of the key tools for obtaining information about the molecule, the analytical method and about the process development and production. Hence, it is recommended that the method development includes foced degradated samples for a better understanding of the method capability and limitations of the method. The aim of the master's thesis was to expose the drug substance to stress conditions in order to determine whether and which of the chosen analytical methods are stability indicating. The chosen drug substance was exposed to various stress conditions: higher temperature, different pH values, addition of an oxidant, addition of a reducing agent, exposure to light, freezing/thawing, (partial) enzymatic deglycosylation, addition of glucose and metal ions. Samples were analyzed with different chromatographic methods (affinity liquid chromatography, reversed-phase chromatography, size exclusion chromatography, capillary gel electrophoresis under non-reducing conditions and under reducing conditions) and the induced differences were evaluated. It has been shown that all the methods except the affinity chromatography are capable to detect changes in the drug substance. Furthermore, the study showed that the studied protein is quite stable under various extreme laboratory conditions: broad temperature and pH ranges, exposure to artificial light, multiple freeze/thaw cycles.
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