Objective
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.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- natural sciences biological sciences biochemistry biomolecules proteins
- medical and health sciences basic medicine pharmacology and pharmacy pharmaceutical drugs vaccines
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Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
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Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Coordinator
MADRID
Spain
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.