The EMA validates Algenex's CrisBio® technology platform, for the manufacture of vaccines

Last June, the European Medicines Agency (EMA) recommended the approval of a biologic produced using the disruptive CrisBio® technology, developed and patented by the Spanish biotechnology company Algenex. This European recommendation has validated the use of this technology to produce recombinant biologics and biocomponents. 

CrisBio® is a platform based on the expression of baculovirus vectors using insects as natural single-use bioreactors.  This technology represents a new paradigm in biologics production as it offers a rapid and easily scalable solution to meet the global demand for recombinant protein production, without the need for a large investment. 

The positive opinion of the EMA's Committee for Medicinal Products for Veterinary Use (CVMP) was issued for a proprietary recombinant RHDV1 and RHDV2 subunit vaccine developed and manufactured using CrisBio® technology.

For Claudia Jimenez, CEO of Algenex: "The positive opinion of the EMA for a vaccine developed with CrisBio® represents a significant regulatory validation and an important step to implement its commercial use. This decision highlights the quality of our technology and underlines the potential of CrisBio® as a strong and versatile alternative to current expression technologies based on large industrial bioreactors, offering superior scalability and performance at lower costs".  

The validation by the EMA of the first product developed with CrisBio® has been a boost for Algenex which is working to expand the use of this platform in a wide range of products for both human and animal health including vaccines, single domain antibodies, enzymes, growth factors and diagnostic reagents.

In addition to its broad applicability, CrisBio®'s rapid and easily scalable production technology enables it to meet a worldwide demand for recombinant proteins without the need for a large investment. Algenex plans to have its facilities certified according to Good Manufacturing Practices (GMP) by 2021. 

For more information: www.algenex.com.