Periodic Reporting for period 4 - EVAg (European Virus Archive goes global)
Periodo di rendicontazione: 2019-12-01 al 2020-07-31
The major objective of the EVAg project is to meet the needs of scientists worldwide by generating a carefully authenticated human/animal virus collection that is larger than any existing repository, and which is readily available to all laboratories that meet approved ethical, safety and security standards. By extensive exploitation of the web and incorporation of appropriate teaching/training courses, EVAg will provide a valuable resource for all human and animal health-related disciplines in academia, fundamental and applied research, the education sector and public and environmental health. A carefully chosen core group of high calibre International laboratories has been selected. One of the key features of this project will be the implementation of platforms dedicated to providing access to the entire EVAg resource, including virus discovery techniques, sequencing and derived material production for diagnostic applications. The partner list includes 45 partners (10 laboratories are from non-EU MS). It also includes 17 associated partners from EU and non-EU MS, who are all ready to share resource and know-how. EVAg is conceived as an international virus collection collecting viruses all over the world, and has the objective not only to reflect the infinite biodiversity of the material but also to support effectively the response to any emerging viral disease.
The 1st part of the work performed has been to assess and create an inventory of the resource, the skills and the technical features available inside the consortium, as related to:
- the collection of viruses ranging from RG2 to RG4, including protocols for virus characterization, isolation, preservation and inactivation
- the production of derived materials including antibodies and antigens, reagents for PCR assays and protein expression systems
- the use of small animal models, including both vertebrate and invertebrate in vivo systems, to study infectivity of viruses from RG2 to RG4 in the context of vector-borne infection
The consortium gives access to “gold standard” material by the use of the up-to-date techniques. A quality manager heads a group of quality experts representing the EVAg institutes. The Quality management system in place includes internal audits, recommendations and guidelines related to GMP. Audits have been carried out and the 1st Quality reports have been drafted and discussed with the institutes visited for follow up at the practice level.
The initial source of the material in the archive was that in collections of the partners of the past EVA project. The extension of this catalog will be achieved through 2 means. The 1st relies on the extension of the network by the incorporation of new partners from EU and non-EU countries. Agreements with new key institutes or networks have been signed. Also, the association of partners belonging to other networks is formalized through a MoU, and includes partners of the GABRIEL and the IP Extra-Metropolitan networks. The 2nd means concerns the identification of very specific collections in low-income countries.
A specific task is dedicated to the support provided in the case of a major virus outbreak at the worldwide scale. The support consists of the provision of material and skills to manage the control of emerging viral diseases. Two recent outbreaks have already drawn on EVAg’s Support to response. During the EBOLA outbreak many partners were mobilized to send their staff on the field in the Western African countries. During the ZIKA outbreak, partners invested time and resources in the preparation of reagents to improve molecular and serological assays to detect the disease and to diagnose infected patients. Specific assistance has also been provided to the pharmaceutical industry for the preparation of drugs and vaccines, and license agreements are under negotiation.
The supply of bio-resource includes 2 major aspects. The 1st is to organize and to expand what the archive offers; the 2nd is to organize and to develop the supply of material to end users.
Since the beginning of the project major improvements to the website have been implemented to increase attractiveness and accessibility. Approximately 200 visits are recorded every day. The public catalog contains 1120 products, 500 additional products are currently in the quality improvement process.
A specific centralized procedure has been implemented to facilitate the supply of the bio-resource to end user. The supply activity curve exceeds the trends of the past EVA project, since the start of the EVAg project: 800 products have been supplied.
The objectives of the Transfer of Knowledge dimension are, for the internal communication, to generate a sense of community in the Consortium and to enhance the number of products available in the database; concerning the external communication, to generate more visits to the catalog, to disseminate and to promote activities and results, to communicate with external stakeholders.
At the start of EVAg, management activities were concentrated on the drafting of legal documents (CA, MTA, MoU) and on their adoption by the partners. An exhaustive assessment of the networks and related infrastructures with whom we must still enter into formal collaborations has been prepared.
EVAg has already tight connections with relevant key ESFRI infrastructures (BBMRI-ERIC, ERINHA, MIRRI). To reach a stage where further integration development could be foreseen, a well document business plan has to be drafted to support the business model which currently exists.
- the collection of viruses ranging from RG2 to RG4, including protocols for virus characterization, isolation, preservation and inactivation
- the production of derived materials including antibodies and antigens, reagents for PCR assays and protein expression systems
- the use of small animal models, including both vertebrate and invertebrate in vivo systems, to study infectivity of viruses from RG2 to RG4 in the context of vector-borne infection
The consortium gives access to “gold standard” material by the use of the up-to-date techniques. A quality manager heads a group of quality experts representing the EVAg institutes. The Quality management system in place includes internal audits, recommendations and guidelines related to GMP. Audits have been carried out and the 1st Quality reports have been drafted and discussed with the institutes visited for follow up at the practice level.
The initial source of the material in the archive was that in collections of the partners of the past EVA project. The extension of this catalog will be achieved through 2 means. The 1st relies on the extension of the network by the incorporation of new partners from EU and non-EU countries. Agreements with new key institutes or networks have been signed. Also, the association of partners belonging to other networks is formalized through a MoU, and includes partners of the GABRIEL and the IP Extra-Metropolitan networks. The 2nd means concerns the identification of very specific collections in low-income countries.
A specific task is dedicated to the support provided in the case of a major virus outbreak at the worldwide scale. The support consists of the provision of material and skills to manage the control of emerging viral diseases. Two recent outbreaks have already drawn on EVAg’s Support to response. During the EBOLA outbreak many partners were mobilized to send their staff on the field in the Western African countries. During the ZIKA outbreak, partners invested time and resources in the preparation of reagents to improve molecular and serological assays to detect the disease and to diagnose infected patients. Specific assistance has also been provided to the pharmaceutical industry for the preparation of drugs and vaccines, and license agreements are under negotiation.
The supply of bio-resource includes 2 major aspects. The 1st is to organize and to expand what the archive offers; the 2nd is to organize and to develop the supply of material to end users.
Since the beginning of the project major improvements to the website have been implemented to increase attractiveness and accessibility. Approximately 200 visits are recorded every day. The public catalog contains 1120 products, 500 additional products are currently in the quality improvement process.
A specific centralized procedure has been implemented to facilitate the supply of the bio-resource to end user. The supply activity curve exceeds the trends of the past EVA project, since the start of the EVAg project: 800 products have been supplied.
The objectives of the Transfer of Knowledge dimension are, for the internal communication, to generate a sense of community in the Consortium and to enhance the number of products available in the database; concerning the external communication, to generate more visits to the catalog, to disseminate and to promote activities and results, to communicate with external stakeholders.
At the start of EVAg, management activities were concentrated on the drafting of legal documents (CA, MTA, MoU) and on their adoption by the partners. An exhaustive assessment of the networks and related infrastructures with whom we must still enter into formal collaborations has been prepared.
EVAg has already tight connections with relevant key ESFRI infrastructures (BBMRI-ERIC, ERINHA, MIRRI). To reach a stage where further integration development could be foreseen, a well document business plan has to be drafted to support the business model which currently exists.
4 points constitute bottlenecks to efficient development in modern Virology, and hence are identified as opportunities for EVAg to make an impact:
1. To move well beyond the current state-of-the-art in establishing validated SOP for virus isolation, identification, production and storage
2. The quality of the product currently offered corresponds to the end user needs
3. The diversity of the items and the procedure used for the supply of the material allow any end user to have easy and secure access to the resource
4. National biosafety regulations increasingly limit the possibility to exchange materials. Consequently, discussions (WHO is involved) have been initiated to obtain specific agreement between well-identified partners inside a specific framework concerning the response to emergence of virus diseases.
EVAg has a strong capacity to develop the initial platform and create a unique and essential system able to respond to academic and industrial needs in virus research and development. Several recent emerging viral epidemics serve as a reminder of our need to face the strategic issue of a global and efficient capacity to meet and control such international crises.
To sum up in 3 points, the main advances of EVAg, this consortium is the largest international collection of mammalian human and animal viruses (also fish and arthropod virus collections). Key features added to the repository are metadata related to the viruses including full genome sequence, certificate of origin, and High standard quality certification; offers a complete databases related to virus-derived products for the development of molecular and serological diagnostic tests; offers an access to high containment facilities and to high risk pathogen laboratories (BSL3&4), the provision of service to end user, including the industrial sector, through access to a specialized platform.
1. To move well beyond the current state-of-the-art in establishing validated SOP for virus isolation, identification, production and storage
2. The quality of the product currently offered corresponds to the end user needs
3. The diversity of the items and the procedure used for the supply of the material allow any end user to have easy and secure access to the resource
4. National biosafety regulations increasingly limit the possibility to exchange materials. Consequently, discussions (WHO is involved) have been initiated to obtain specific agreement between well-identified partners inside a specific framework concerning the response to emergence of virus diseases.
EVAg has a strong capacity to develop the initial platform and create a unique and essential system able to respond to academic and industrial needs in virus research and development. Several recent emerging viral epidemics serve as a reminder of our need to face the strategic issue of a global and efficient capacity to meet and control such international crises.
To sum up in 3 points, the main advances of EVAg, this consortium is the largest international collection of mammalian human and animal viruses (also fish and arthropod virus collections). Key features added to the repository are metadata related to the viruses including full genome sequence, certificate of origin, and High standard quality certification; offers a complete databases related to virus-derived products for the development of molecular and serological diagnostic tests; offers an access to high containment facilities and to high risk pathogen laboratories (BSL3&4), the provision of service to end user, including the industrial sector, through access to a specialized platform.