Time stability studies of biotechnological medicines — monoclonal antibodies and fusion proteins -. Comprehensive conformational studies. (Q3161520): Difference between revisions
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(Created claim: summary (P836): The use of therapeutic proteins such as monoclonal antibodies and fusion proteins is currently consolidated in the treatment of diseases of high prevalence (cancer and autoimmune diseases), mainly of hospital use. These biotechnological medicines have in common their high price, which translates into the greatest impact on hospital pharmaceutical spending. The stability studies of the pharmaceutical industry are aimed at meeting the marketing re...) |
(Changed label, description and/or aliases in en: translated_label) |
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Time stability studies of biotechnological medicines — monoclonal antibodies and fusion proteins -. Comprehensive conformational studies. | |||
Revision as of 17:08, 12 October 2021
Project Q3161520 in Spain
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | Time stability studies of biotechnological medicines — monoclonal antibodies and fusion proteins -. Comprehensive conformational studies. |
Project Q3161520 in Spain |
Statements
61,600.0 Euro
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77,000.0 Euro
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80.0 percent
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1 January 2018
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31 March 2021
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FUNDACION PARA LA INVESTIGACION BIOSANITARIA DE ANDALUCIA ORIENTAL - ALEJANDRO OTERO
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37°10'24.60"N, 3°35'58.31"W
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18087
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El uso de proteínas terapéuticas tales como anticuerpos monoclonales y proteínas de fusión, está actualmente consolidado en el tratamiento de enfermedades de gran prevalencia (cáncer y enfermedades autoinmunes), siendo de uso hospitalario principalmente. Estos medicamentos biotecnológicos tienen en común su elevado precio que se traduce en el mayor impacto sobre el gasto farmacéutico hospitalario. Los estudios de estabilidad de la industria farmacéutica van dirigidos a cumplir los requisitos de comercialización, mientras que la estabilidad en las condiciones de la práctica clínica está frecuentemente limitada a 24 h. Dada la administración de estos medicamentos por peso del paciente, se generan importantes sobrantes de los mismos, que adecuadamente estudiados podrían ser reutilizados con total eficacia y seguridad. La complejidad a la hora de evaluar la estabilidad de estas proteínas es lo que frena este tipo de estudios. Los resultados de un anterior proyecto - pionero en el tema- han puesto de manifiesto gran estabilidad fisco-química de 5 de estos medicamentos, pero sólo se corrobora estabilidad funcional -evaluada por ELISA- para uno de ellos. En este proyecto se propone aplicar técnicas avanzadas de caracterización estructural de alta resolución combinadas con estudios de funcionalidad/actividad biológica, para dilucidar sobre la estabilidad en estos casos que las técnicas más generalistas no aportan resultados concluyentes. Se propone también la incorporación en los estudios de estabilidad de los sobrantes de otros cinco medicamentos biotecnológicos de alto impacto económico. (Spanish)
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The use of therapeutic proteins such as monoclonal antibodies and fusion proteins is currently consolidated in the treatment of diseases of high prevalence (cancer and autoimmune diseases), mainly of hospital use. These biotechnological medicines have in common their high price, which translates into the greatest impact on hospital pharmaceutical spending. The stability studies of the pharmaceutical industry are aimed at meeting the marketing requirements, while the stability in the conditions of clinical practice is often limited to 24 h. Given the administration of these drugs by weight of the patient, important surpluses are generated, which properly studied could be reused with total efficacy and safety. The complexity of assessing the stability of these proteins is what slows down this type of study. The results of a previous project — a pioneer in the subject — have shown great fiscal-chemical stability of 5 of these medicines, but only one of them is corroborated functional stability — evaluated by ELISA. In this project it is proposed to apply advanced high-resolution structural characterisation techniques combined with biological functionality/activity studies, in order to elucidate stability in these cases that the more generalistic techniques do not yield conclusive results. It is also proposed that five other biotechnological medicinal products with high economic impact be incorporated into the stability studies of surpluses. (English)
12 October 2021
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Granada
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Identifiers
PI17_00547
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