Fatro secures European authorization for rabbit vaccine with Algenex tech

Fatro secures European authorization for rabbit vaccine with Algenex tech 24 Sep 2021 – Animal Health | Headline AnalysisProduct Approvals

  • The European Commission has granted marketing approval to a rabbit hemorrhagic disease virus (RHDV) from Italian business Fatro.The vaccine incorporates CrisBio technology developed by Spain’s Algenex. The UK Veterinary Medicine Directorate also issued an approval for the product.Fatrovax RHD is a recombinant subunit RHDV1 and RHDV2 vaccine. It is manufactured using CrisBio, which provides a baculovirus vector-mediated expression platform that “harnesses the power of insects to act as natural single-use bioreactors”. Algenex believes its technology offers a quick and scalable way to meet the global demand for recombinant protein production without significant costs.The European registration follows a recommendation for approval from the Committee for Medical Products earlier this year.

    Algenex said RHDV is endemic in most parts of the world. It causes a highly contagious, acute and fatal disease. The virus “does not replicate in vitro and the production of protective antigens by recombinant baculovirus avoids the need to use live rabbits in the manufacture of RHD vaccines”.

    The Madrid-based firm added: “The CrisBio platform offers a number of benefits that include reduced production costs and increased productivity reaching gram per liter yields, significantly outperforming alternative baculovirus vector approaches. The CrisBio platform is rapidly scalable, with Algenex’s capacity currently geared for commercial-scale production. Algenex anticipates its facilities will be fully GMP-compliant by the end of the year.”

    Fatro is also collaborating with Algenex on additional products that use the latter’s technology. Bologna-headquartered Fatro – the leading domestic animal health business in Italy – is working with Algenex on another vaccine for an unspecified indication in pigs.

    Earlier this year, Algenex secured an international commercial licensing agreement with Virbac for the development and commercialization of a vaccine for an unnamed “major swine indication” using the CrisBio technology.

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