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First Algenex CrisBio®-based vaccine submitted to European Medicines Agency
PRESS RELEASE First Algenex CrisBio®-based vaccine submitted to European Medicines Agency Potential approval would validate the use of Algenex’ CrisBio® technology for the manufacture of recombinant subunit vaccines Madrid (Spain), October 15, 2019 – Algenex SL, a private biotechnology company delivering disruptive technologies for recombinant biologics production, today announces that one of its industry partners has submitted a dossier to the European Medicines Agency (EMA) for a recombinant VLP vaccine produced using Algenex’ proprietary CrisBio® technology. The submission is targeting a European marketing authorization via the centralized approval system. This is the first vaccine produced using Algenex’ CrisBio® technology to be submitted for regulatory approval. CrisBio® is Algenex’ proprietary and patent protected Baculovirus vector-mediated expression platform that harnesses the power of insects to act as natural single-use bioreactors. It is a versatile and robust alternative to current bioreactor-based expression technologies and offers additional benefits including linear scalability, reducedproduction costs and increased productivity, reaching gram per litre yields. “CrisBio® has the potential to transform recombinant protein production and this first submission to the EMA by one of our industry partners is a key milestone for Algenex,” said Claudia Jiménez, General Manager of Algenex. “A potential approval would serve as regulatory validation and pave the way for future regulatory submissions for both vaccines and other biological products. We continue to work closely with our partners to deliver on our mission to be the partner of choice for the production and manufacture of protein-based products.” For further information, please contact: Algenex contact About Algenex Algenex is a private biotechnology company developing disruptive Baculovirus-based technologies for the production of recombinant biologics. Algenex´ first two platforms, TopBac® and CrisBio®, are based on baculovirus-based expression systems and have demonstrated their capacity to transform recombinant protein production through a process that provides almost unlimited and immediate scalability of manufacturing, production flexibility, simplicity and versatility while being extremely cost efficient. To date, Algenex’ work has centred mainly on the development and production of veterinary vaccines, with > 200 molecules successfully produced in collaboration with public and private partners, including multiple international pharmaceutical companies. Algenex plans to expand the application of its proprietary and patented technologies into human health in order to fully exploit the potential of its platforms.
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