Multi-level approaches for the proteoform characterization of therapeutic antibodies by mass spectrometry

Grunert, I.F.K.

Nowadays, therapeutic antibodies are the major and fastest growing class of biotherapeuticals. Since their invention, they are continuously developed to improve structural and functional characteristics. The high complexity of recently generated antibody derivatives, with various modifications induced during the manufacturing process itself leads to many proteoform variants of the desired product. These proteoforms can potentially exhibit altered activity. Therefore, an adequate characterization of the proteoforms, the assessment of their impact and careful monitoring of critical species is indispensable in order to guarantee effective and safe biopharmaceuticals. As the landscape of next-generation Ab formats continuously evolves, it is likewise of great importance to further develop appropriate analytical methods for their thorough attribute analysis. Hence, the focus of the research performed in this thesis is the development of multi-level approaches for the in-depth,...Show moreNowadays, therapeutic antibodies are the major and fastest growing class of biotherapeuticals. Since their invention, they are continuously developed to improve structural and functional characteristics. The high complexity of recently generated antibody derivatives, with various modifications induced during the manufacturing process itself leads to many proteoform variants of the desired product. These proteoforms can potentially exhibit altered activity. Therefore, an adequate characterization of the proteoforms, the assessment of their impact and careful monitoring of critical species is indispensable in order to guarantee effective and safe biopharmaceuticals. As the landscape of next-generation Ab formats continuously evolves, it is likewise of great importance to further develop appropriate analytical methods for their thorough attribute analysis. Hence, the focus of the research performed in this thesis is the development of multi-level approaches for the in-depth, primarily MS-based characterization of biopharmaceuticals to overcome the present restrictions and challenges arising e.g. by the implementation of complex Ab formats.
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Multi-level approaches for the proteoform characterization of therapeutic antibodies by mass spectrometry

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