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2011 Call for projects in the field of viral safety for biological products
   
  » Outcome

The Alliance BioSecure Foundation, recognized as a public utility since December 2006, has been established to improve analysis, understanding and management of public health risks related to current or emerging microbiological agents. The foundation, initially focused in the field of prion research, wishes to enlarge its scope to viral safety of biologicals on the topic of emerging viruses.

Outcome 1st Call for projects in the field of Viral Safety for Biological Products

The two following categories have been considered:

  1. Research, development and/ or validation of methods/ models aimed to remove or inactivate non-enveloped viruses notably in the production of biological products, and in the decontamination of instruments and surfaces.
  2. High throughput sequencing: applications to viral safety of biologicals

Scientific Evaluation:

  • Pr Francis Barin (Tours)
  • Pr Jacques-Christian Darbord (Paris)
  • Pr Marc Eloit (Maison Alfort / Institut Pasteur)
  • Pr Bruno Pozzetto (St Etienne)
  • Pr Jean-Marie Seigneurin (Grenoble)

Evaluation Process

Projects first submitted as abstracts were assessed independently by each expert, The evaluation were collected, consolidated and blinded. In case of conflict of interest, the expert didn’t participate to the evaluation of the category. Final abstract selection for full dossier was performed during a meeting and validated by the Bureau.
Full dossier evaluation followed the same procedure with a further validation by the executive committee.

4 projects were selected for funding

Category 1

  • Projet DIAHEV : Development of an Infectivity Assay for Hepatitis E virus

    Funding: 36 600 €
    Principal investigator : Pr Jacques Izopet, Chef de Service, Laboratoire de Virologie, Institut Fédératif de Biologie, Hôpital Purpan, CHU de Toulouse, France
    Co-investigators : Steve Simoneau, Catherine Visse, Bruno You et Benoit Flan Direction Gestion du Risque et veille Qualité et Sécurité Biologique, LFB Biomédicament - Les Ulis.

    Aim of the project: Hepatitis E virus (HEV) genotypes 1 and 2 infect only humans and are responsible of epidemics transmitted by faecal-oral route in developing countries and sporadic imported cases in industrialized countries. Genotypes 3 and 4 can be found in humans and animal reservoirs (swine, wild boar, deer) in industrialized countries supporting autochthonous zoonotic transmission. Nosocomial and transfusion-transmitted infections have also been reported.
    Fulminant hepatitis occurs in the context of pre-existing liver disease or during pregnancy. Acute hepatitis E can also lead to chronic infection and cirrhosis in immunocompromised patients. However, more than 50% of infections are asymptomatic.

    We propose to develop an infectivity assay for hepatitis E virus and to apply this system for evaluating the safety of medicinal products derived from human plasma

  • Projet SYNPOLYVIR : Synthetic Polymers for improved safety of blood products

    Funding: 43 000 €
    PrincipaI investigator: Dr Juraj Petrik, Scottish National Blood Transfusion Service, Edinburgh 
    Co-investigators: Pr Mark Bradley, The school of chemistry, University of Edinburgh and Dr Michael Jones, SNBTS.

    Aim of the project:  The safety of transfused blood and blood products in relation to blood borne pathogens is achieved through a combination of measures: donor selection, testing of donated blood and use of pathogen reduction/inactivation technologies (PRT). Current microbiological testing is very efficient, but cannot guarantee 100 % detection, especially during the so-called “window period” – a period between the infection and the presence of the pathogen at detectable levels. This period is different for different pathogens and tests (days – weeks) and during this period minute quantities of pathogen cannot be detected. Also, the screening tests can test only known pathogens. PRT can deal with some of these issues, but suffers from a lower efficiency of reduction/inactivation for some non-enveloped viruses. An alternative and/or complementary approach would be to remove the difficult-to-inactivate viruses using specific polymers. Specific antibodies could, in principle be used for this purpose, but the approach is expensive and technically demanding. Synthetic polymers represent a much cheaper, simpler and scaleable option. This project aims at the identification of synthetic polymers specific for binding model, non-enveloped viruses, and their initial evaluation for large-scale application.

Category 2

  • Projet VIRUS-BIOL-HTS : Validation of a High Throughput Sequencing pipeline and application to the description of the viral bioburden of raw materials used in the manufacture of major biological products

    Funding: 67 500 €
    Principal Investigator: Pr Marc Eloit, Professor of Virology, Ecole Nationale Vétérinaire d’Alfort and Department of Virology, Institut Pasteur; Head of the program Pathodisc, Institut Pasteur, Paris.
    Co-investigators: Dr Jean Claude Manuguerra   Cellule d’Intervention Biologique d’urgence, Institut Pasteur and Valérie Caro, platform PF8, Institut Pasteur.

    Aim of the project: In the recent past, there has been a very fast increase of High Throughput Sequencing (HTS) usage in microbiology, whose main output was the discovery of new or unexpected human and animal viruses, including adventitious viruses in some biologicals as human pediatric live vaccines. During the last two years, we have validated a pipeline, from sample extraction to bioinformatic analysis, and used it to test numerous human and animal samples and to discover several new human viruses. We also showed that the limit of detection was close or better than PCRs for known viruses. This confers to negative results a high negative predictive value, which is a function of the type of HTS technique and the depth of sequencing. So, HTS has the capacity to increase the guarantees regarding the risks of viral contamination of biological products. The project submitted here has the objective to evaluate the usefulness of HTS at providing manufacturers with a “viroburden”, which can be used to conduct the risk analysis requested by the different regulatory guidelines in the field of viral safety. To do so, we will describe the virome of major raw materials used for the manufacture of animal (heparins) and human (plasma derivative) biological active ingredients, as well as cell culture reagents (trypsin, fetal calf serum and SPF eggs).

  • Projet VIROSCAN : Development of a panvirus capture system for viral génome enrichment before NGS sequencing.

    Funding: 44 000 €
    Principal investigator: Joel Lachuer, Director ProfileXpert, Lyon, France
    Co - investigator: Catherine Legras-Lachuer, Scientfic director ProfileXpert
    Partner: Dominique Rigal, Director EFS Lyon, France

    Aim of the project:  The risk of viral contamination is a feature common to all biotechnology products derived from cell lines: stem cell lines used for vaccine, cell therapy, blood products and organ transplants. These risks of viral contamination and the unexpected appearance of some other emerging pathogens are subject for several years increasing attention, by the authorities for registration. Several approaches have been implemented to control the potential viral contamination of biotechnology products including: selection and testing cells lines, testing media components for the absence of pathogenic virus for human, assessment of virus removal or inactivation and testing the product at different steps of production for absence of contaminating viruses. The assessment of virus absence is achieved, to date, by conventional tests targeted on virus candidates. For example, in the cases of blood products or organ transplants, the major transmissible viruses (HIV-1, HIV-2, HBV and HCV, HTLV-1, HTLV-2) are subject to routing screenings in Europe blood banks. But, several other known viruses, other emergent or re-emergent viruses that are not screened to date, could be transmitted via transfusion or organ transplant. Innovating sequencing technologies allow the detection of all pathogens and may become, in a near future, a method of choice to ensure the virus safety of biotechnology and biological products. Nevertheless, several points should still be improved including the sensitivity of pathogen detection. For this purpose, we propose to develop a method to enrich viral genome sequences in order to enhance the sensitivity of viral detection prior to sequencing. The efficiency of enrichment will be performed on in vitro blood-borne infected cells and on positive blood bag samples obtained from the EFS.
 
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