Algenex 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, reduced production 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.”Download