EMER-FAB

Development, regulatory validation and production of new specific polyclonal immunoglobulin against the Crimean Congo Hemorrhagic Fever Virus (CCHFV)

EMER-FAB est accrédité par Lyonbiopôle

Identity card

Global budget: 2486 k€

Public funding: 1357 k€

Public funders: Fonds Unique Interministériel (FUI) – DGCIS/Oséo, Grand Lyon

Call for projects: FUI (FUI AAP10)

Year start: 2010

Completed project (2016-12)


Accredited by the French competitiveness cluster Lyonbiopôle


Strategic business area: Human Medicines

Application fields: Infectious diseases

Technological approaches / Keywords: Immunotherapy, Vector vaccine

Stage of development at the beginning of the project: Preclinical development

Abstract

The project is dedicated to the development and the regulatory validation of an original and complete model for the development and production of immunotherapeutic solutions against the CCHF virus (Crimean Congo Hemorrhagic Fever). The virus causes severe hemorrhagic fever. It occurs in Africa, Eastern Europe and Turkey, where it represents, in the absence of any satisfactory therapeutic solution, a public health issue for those who are directly exposed, in particular healthcare workers.


Objectives

- Identify and select the appropriate CCHF viral strain among various circulating species. - Develop CCHF antigens to be used for horse hyperimmunisation (VLP...) - Validate a Proof of concept both in vitro (development of specific in vitro assays) and in vivo (development of an animal model for CCHF infection by the BSL-4 laboratory). - Develop a GMP assay to quantify the activity of specific anti-CCHF antibodies for the release of clinical and commercial batches. - Production of specific polyclonal immunoglobulin against the CCHF virus.


Innovative assets
Highlights
Actual results
Perspectives

Innovative assets

-Development of Virus-Like-Particule CCHF -DNA vectorization of VLP -Production and purification of specific anti-CCHFV immunoglobulins -Development of in vitro and in vivo tools for CHCF laboratory-studies

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