Assessment of Physicochemical Properties of Rituximab Related to Its Immunomodulatory Activity
Rituximab is a chimeric monoclonal antibody employed for the treatment of CD20-positive B-cell non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis. It binds specifically to the CD20 antigen expressed on pre-B and c...
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| Format: | Article |
| Language: | English |
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Wiley
2015-01-01
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| Series: | Journal of Immunology Research |
| Online Access: | http://dx.doi.org/10.1155/2015/910763 |
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| author | Mariana P. Miranda-Hernández Carlos A. López-Morales Nancy D. Ramírez-Ibáñez Nelly Piña-Lara Nestor O. Pérez Aarón Molina-Pérez Jorge Revilla-Beltri Luis F. Flores-Ortiz Emilio Medina-Rivero |
| author_facet | Mariana P. Miranda-Hernández Carlos A. López-Morales Nancy D. Ramírez-Ibáñez Nelly Piña-Lara Nestor O. Pérez Aarón Molina-Pérez Jorge Revilla-Beltri Luis F. Flores-Ortiz Emilio Medina-Rivero |
| author_sort | Mariana P. Miranda-Hernández |
| collection | DOAJ |
| description | Rituximab is a chimeric monoclonal antibody employed for the treatment of CD20-positive B-cell non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis. It binds specifically to the CD20 antigen expressed on pre-B and consequently on mature B-lymphocytes of both normal and malignant cells, inhibiting their proliferation through apoptosis, CDC, and ADCC mechanisms. The immunomodulatory activity of rituximab is closely related to critical quality attributes that characterize its chemical composition and spatial configuration, which determine the recognition of CD20 and the binding to receptors or factors involved in its effector functions, while regulating the potential immunogenic response. Herein, we present a physicochemical and biological characterization followed by a pharmacodynamics and immunogenicity study to demonstrate comparability between two products containing rituximab. The physicochemical and biological characterization revealed that both products fit within the same response intervals exhibiting the same degree of variability. With regard to clinical response, both products depleted CD20+ B-cells until posttreatment recovery and no meaningful differences were found in their pharmacodynamic profiles. The evaluation of anti-chimeric antibodies did not show differential immunogenicity among products. Overall, these data confirm that similarity of critical quality attributes results in a comparable immunomodulatory activity. |
| format | Article |
| id | doaj-art-1a8f5c046de84cd6b293245a82d39fb9 |
| institution | Kabale University |
| issn | 2314-8861 2314-7156 |
| language | English |
| publishDate | 2015-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Immunology Research |
| spelling | doaj-art-1a8f5c046de84cd6b293245a82d39fb92025-02-03T06:12:10ZengWileyJournal of Immunology Research2314-88612314-71562015-01-01201510.1155/2015/910763910763Assessment of Physicochemical Properties of Rituximab Related to Its Immunomodulatory ActivityMariana P. Miranda-Hernández0Carlos A. López-Morales1Nancy D. Ramírez-Ibáñez2Nelly Piña-Lara3Nestor O. Pérez4Aarón Molina-Pérez5Jorge Revilla-Beltri6Luis F. Flores-Ortiz7Emilio Medina-Rivero8Unidad de Investigación y Desarrollo, Probiomed S.A. de C.V., Cruce de carreteras Acatzingo-Zumpahuacán, 52400 Tenancingo de Degollado, MEX, MexicoUnidad de Investigación y Desarrollo, Probiomed S.A. de C.V., Cruce de carreteras Acatzingo-Zumpahuacán, 52400 Tenancingo de Degollado, MEX, MexicoUnidad de Investigación y Desarrollo, Probiomed S.A. de C.V., Cruce de carreteras Acatzingo-Zumpahuacán, 52400 Tenancingo de Degollado, MEX, MexicoUnidad de Investigación y Desarrollo, Probiomed S.A. de C.V., Cruce de carreteras Acatzingo-Zumpahuacán, 52400 Tenancingo de Degollado, MEX, MexicoUnidad de Investigación y Desarrollo, Probiomed S.A. de C.V., Cruce de carreteras Acatzingo-Zumpahuacán, 52400 Tenancingo de Degollado, MEX, MexicoDirección Médica, Probiomed S.A. de C.V., Avenida Ejército Nacional No. 499, Colonia Granada, Delegación Miguel Hidalgo, 11520 México, DF, MexicoDirección Médica, Probiomed S.A. de C.V., Avenida Ejército Nacional No. 499, Colonia Granada, Delegación Miguel Hidalgo, 11520 México, DF, MexicoUnidad de Investigación y Desarrollo, Probiomed S.A. de C.V., Cruce de carreteras Acatzingo-Zumpahuacán, 52400 Tenancingo de Degollado, MEX, MexicoUnidad de Investigación y Desarrollo, Probiomed S.A. de C.V., Cruce de carreteras Acatzingo-Zumpahuacán, 52400 Tenancingo de Degollado, MEX, MexicoRituximab is a chimeric monoclonal antibody employed for the treatment of CD20-positive B-cell non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis. It binds specifically to the CD20 antigen expressed on pre-B and consequently on mature B-lymphocytes of both normal and malignant cells, inhibiting their proliferation through apoptosis, CDC, and ADCC mechanisms. The immunomodulatory activity of rituximab is closely related to critical quality attributes that characterize its chemical composition and spatial configuration, which determine the recognition of CD20 and the binding to receptors or factors involved in its effector functions, while regulating the potential immunogenic response. Herein, we present a physicochemical and biological characterization followed by a pharmacodynamics and immunogenicity study to demonstrate comparability between two products containing rituximab. The physicochemical and biological characterization revealed that both products fit within the same response intervals exhibiting the same degree of variability. With regard to clinical response, both products depleted CD20+ B-cells until posttreatment recovery and no meaningful differences were found in their pharmacodynamic profiles. The evaluation of anti-chimeric antibodies did not show differential immunogenicity among products. Overall, these data confirm that similarity of critical quality attributes results in a comparable immunomodulatory activity.http://dx.doi.org/10.1155/2015/910763 |
| spellingShingle | Mariana P. Miranda-Hernández Carlos A. López-Morales Nancy D. Ramírez-Ibáñez Nelly Piña-Lara Nestor O. Pérez Aarón Molina-Pérez Jorge Revilla-Beltri Luis F. Flores-Ortiz Emilio Medina-Rivero Assessment of Physicochemical Properties of Rituximab Related to Its Immunomodulatory Activity Journal of Immunology Research |
| title | Assessment of Physicochemical Properties of Rituximab Related to Its Immunomodulatory Activity |
| title_full | Assessment of Physicochemical Properties of Rituximab Related to Its Immunomodulatory Activity |
| title_fullStr | Assessment of Physicochemical Properties of Rituximab Related to Its Immunomodulatory Activity |
| title_full_unstemmed | Assessment of Physicochemical Properties of Rituximab Related to Its Immunomodulatory Activity |
| title_short | Assessment of Physicochemical Properties of Rituximab Related to Its Immunomodulatory Activity |
| title_sort | assessment of physicochemical properties of rituximab related to its immunomodulatory activity |
| url | http://dx.doi.org/10.1155/2015/910763 |
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