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Identification of critical quality attributes (CQAs) is an important step for development of biopharmaceuticals with intended performance. An accurate CQA assessment is needed to ensure product quality and focusing on development efforts where control is needed. The assignment of criticality is based on safety and efficacy. Efficacy is related to PK and bioactivity. Here, we developed a novel approach based on antibody-antigen complex structure and modeling as a complementary method for bioactivity assessment. To validate this approach, c

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to secondary progressive MS, and DMT effectiveness uncertainty. Patient centred decision aids should include information about first and consecutive treatment decisions.Dermatographism is a disorder of unknown etiology that results in inducible hives from environmental stimuli. Here we report the first known case of dermatographism associated with ocrelizumab in a patient with relapsing remitting multiple sclerosis. The patient presented with pruritic linear raised rash approximately two weeks after her first infusion with oc