| خلاصه مقاله | Antibodies have numerous applications in research, disease diagnosis, and the treatment of autoimmune diseases and cancers. The use of monoclonal antibodies in the treatment of challenging diseases such as cancers, along with the difficult and costly process of producing these biological products, results in their very high prices. Therapeutic proteins may encounter various stresses during production, transportation, storage, and administration. Mechanical stress is a common method for assessing the stability of therapeutic protein formulations. Under mechanical stress, proteins are subjected to a range of stresses, which also increases the contact of protein molecules with hydrophobic surfaces or air/water interfaces, leading to antibody aggregation and the formation of aggregate products. Aggregation is a common manifestation of protein instability, resulting in the formation of larger, abnormal soluble or insoluble particles with different sizes and morphologies. Aggregation reduces the therapeutic effects of antibodies and increases their immunogenicity, which can lead to severe allergic reactions, such as anaphylactic shock. Rituximab is a chimeric monoclonal antibody against the CD20 protein, and its binding to this protein induces cell death. The monoclonal antibody Zytux (Zytux®), which is a biosimilar to rituximab, is produced by ArioGen Pharmed. In this study, the stability of this antibody under the influence of mechanical stress was investigated concerning aggregation caused by mechanical stress in both concentrated and diluted forms of Zytux (biosimilar rituximab) using size exclusion chromatography |