Exothera S.A., a full-service Contract Development and Manufacturing Organization (CDMO) delivering customized process development and GMP (Good Manufacturing Practices) manufacturing services for gene therapy and viral vector-based vaccines, announces that it has acquired the NevoLineā¢ Upstream manufacturing platform, the latest equipment of Univercells Technologies.
Based on principles of intensification and chaining, this high-performance, low-footprint upstream manufacturing platform is an integrated and automated solution for the cost-effective production of viral vaccines, viral vectors, and oncolytic viruses. Installation of the equipment will be within the state-of-the-art GMP plant, based in Jumet, Belgium (Univercells Campus). This cutting-edge 1,900 mĀ², turn-key facility will offer 900 mĀ² (9690ftĀ²) of GMP production area dedicated to upstream and downstream process development, as well as clinical and commercial GMP manufacturing. On the same campus, a second facility of 5,500 mĀ² (59,200ftĀ²) will be GMP ready in January 2022.
Exothera will use the NevoLine platform for the manufacturing of viral vector-based gene therapiesĀ and viral vaccines. This platform was selected because it offers substantial increases in volumetric productivity, enabling significant development and production cost-reduction opportunity. The scale-X technology at the core of the NevoLine offers predictable scalability from R&D to GMP while accommodating a range of viral targets, offering the flexibility and performance essential to a CDMO such as Exothera.
āOptimizing the production will allow us to have a significant impact on the quantity of product we can manufacture, and the associated Cost of Goods,ā said Christian Borgniet,Ā Chief Operating Officer of Exothera S.A.Ā āCurrent gene therapy treatments are extremely expensive. Exotheraās mission is to make these life-changing therapies affordable to as many patients as possible.Ā The NevoLine platform will help us to reach this goal.ā
āThe installation of the NevoLine technology at Exothera is an important milestone for usā,Ā stated Vasily Medvedev, Head of Development at Exothera. āWe believe that for the target viral vectors processes, the NevoLine system will allow us to reach new levels in productivity and process performance compared to conventional technologies. We are looking forward to using this equipment as a key element in our manufacturing missions.ā