Objetivo
The aim of this proposal is to bring, for the first time, a process of vaccine production from the existing scientific basis to industrial application. The proposed technology is based on the expression of recombinant viral empty capsids in insect cells using the baculovirus expression vector system (BEVS). Most, if not all, of these empty particles show optimal immunological properties that make them suitable candidates for vaccine production. Unfortunately, the industrial use of this technology has been hampered by several factors, including: lack of knowledge of the BEVS culture and recovery conditions for medium and large scale in insect cells, costs of the assessment of vaccine efficacy and safety under field conditions and, finally, the burden and complexity of the regulatory affairs to get the registration of a recombinant vaccine. The production of porcine parvovirus (PPV) virus-like particles (VLPs) has been selected as "proof-of-the-concept" system in order to solve these problems. PPV is responsible for a major reproductive disease in pigs, which is usually controlled by vaccination. Vaccination is mandatory to get profitable pig meat production. PPV VLPs have been successfully expressed in the baculovirus system and shown their protective efficacy at the laboratory level. In a previous preparatory award we have shown that the production costs can be two to four times cheaper than a conventional system.
The project aims to bring an established laboratory scale expression technology into economic, robust and reproducible pilot plan scale production and provide data about the efficacy, safety and stability of the product that guarantee the industrial feasibility of the system. These objectives will be implemented through several integrated work packages. The first package will address the tuning up of the production of recombinant particles in large cultures, to increase VLPs production without variations in product quality (stability, antigenicity and immunogenicity). Second task will include optimization and up-scaling of downstream extraction and purification in order to maximize protein recovery, adjusting these conditions to large volume systems. Final batches of the vaccine will be inactivated with chemical agents (i.e. BEI) to fulfil the regulatory requirements in order to avoid the presence of recombinant genetic material. Other tasks will aim to demonstrate the efficacy and potency of the final product. To this end, different adjuvant combinations will be used for the vaccine formulations and will be tested for dosage, efficacy and potency in pregnant gilts in order to fulfil the requirements of the European Pharmacopoeia for PPV vaccines. Stability of the final formulation will be checked in real time (4°C) or accelerated time (37°C), depending of the final formulation selected. To verify the safety of these vaccines will be a major issue in our proposal: several experiments on different animal species will be carried out to study the effect of parameters such as age, sex, etc. in the response to the vaccine. To comply with the requirements of a demonstration project, the results will be made available to the public and related extended audiences such as vaccine manufacturers, veterinarians, farmers and regulatory affairs experts.
The project is structured so that each objective can be achieved largely independently, which permits consistent progress throughout the contract. The data, collected by the consortium of the project, will determine the key parameters in all aspects of the vaccine production and formulation, which will lead to an optimized protein production for both routine laboratory work and industrial scale up level. It is anticipated that knowledge derived from this study will also be useful for the production of a new and safer generation of vaccines in the veterinary and human fields.
The project clearly addresses the priority area 5.2 of the Biotechnology Workprogramme, the main objectives being development of second generation vaccines more efficient, more economical, safer and easier to deliver. Given the properties of the PPV particles, the results found in this proposal could be particularly useful for the applicability of VLPs and non-live carriers as antigen delivery systems.
Ámbito científico (EuroSciVoc)
CORDIS clasifica los proyectos con EuroSciVoc, una taxonomía plurilingüe de ámbitos científicos, mediante un proceso semiautomático basado en técnicas de procesamiento del lenguaje natural. Véas: El vocabulario científico europeo..
CORDIS clasifica los proyectos con EuroSciVoc, una taxonomía plurilingüe de ámbitos científicos, mediante un proceso semiautomático basado en técnicas de procesamiento del lenguaje natural. Véas: El vocabulario científico europeo..
- ciencias naturales ciencias biológicas bioquímica biomoléculas proteínas
- ciencias médicas y de la salud medicina básica farmacología y farmacia medicamento vacuna
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Programa(s)
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Programas de financiación plurianuales que definen las prioridades de la UE en materia de investigación e innovación.
Tema(s)
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Las convocatorias de propuestas se dividen en temas. Un tema define una materia o área específica para la que los solicitantes pueden presentar propuestas. La descripción de un tema comprende su alcance específico y la repercusión prevista del proyecto financiado.
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Procedimiento para invitar a los solicitantes a presentar propuestas de proyectos con el objetivo de obtener financiación de la UE.
Régimen de financiación
Régimen de financiación (o «Tipo de acción») dentro de un programa con características comunes. Especifica: el alcance de lo que se financia; el porcentaje de reembolso; los criterios específicos de evaluación para optar a la financiación; y el uso de formas simplificadas de costes como los importes a tanto alzado.
Régimen de financiación (o «Tipo de acción») dentro de un programa con características comunes. Especifica: el alcance de lo que se financia; el porcentaje de reembolso; los criterios específicos de evaluación para optar a la financiación; y el uso de formas simplificadas de costes como los importes a tanto alzado.
Coordinador
MADRID
España
Los costes totales en que ha incurrido esta organización para participar en el proyecto, incluidos los costes directos e indirectos. Este importe es un subconjunto del presupuesto total del proyecto.