The new BFS production lines will hold the capacity to fill-finish over 500 million doses per year of vaccines and other large molecule injectable drugs using ApiJect's prefilled injector technology
French pharmaceutical company Fareva has entered into a 10-year licencing agreement with US-based ApiJect Systems for the production of single-dose prefilled vaccine injections using ApiJect’s prefilled injector technology.
The French firm is planning to invest over €50m to install three new blow-fill-seal (BFS) production lines at its Fareva Excelvision facility in Annonay, France. The BFS machines will be acquired from German firm Rommelag.
Fareva will take the support from the French government, through the “France Relance” industry initiative and the Investments for the Future Program (PIA) to secure funding for the project.
The three manufacturing lines and ApiJect’s technology use the BFS aseptic packaging process.
When operational, the new BFS production lines will hold the capacity to fill-finish over 500 million doses per year of vaccines and other large molecule injectable drugs using ApiJect’s prefilled injector technology.
BFS process is already proved to package various vaccines and large molecule formulations, while ApiJect is supporting to expand BFS’s capabilities to additional drug products such as temperature-sensitive pharmaceuticals.
Upon receiving approval from the regulators, ApiJect will deliver the required needle hub and other attachable components for the conversion of finished BFS single-dose containers from these lines into easy-to-assemble and ready-to-use prefilled injectors.
Fareva aims to begin the first validation batches in June next year. It is also planning to expand ApiJect licencing for BFS manufacturing and device technology to the US and Europe.
ApiJect CEO and chair Jay Walker commented: “Our mission at ApiJect is to support and execute a strategy of expanded distributed fill-finish capacity in the US and regionally around the world.
“This is desperately needed in the battle against Covid, particularly as we continue to face emerging variants. Distributed fill-finish capacity will also yield huge dividends when future pandemics and other possible bio-emergencies threaten our populations.
“Fareva, along with its support from the French Government, is showing itself to be a vital leader in confronting and defeating the Covid threat.”