Fareva and ApiJect Systems today announced a licensing agreement to fill-finish more than 500 million injectable drug doses per year.
Under the agreement, Fareva intends to invest more than $56.5 million to install three blow-fill-seal production lines with support from the Government of France through the France Relance industry initiative, as well as the Investments for the Future Program (PIA).
When operational, the companies expect the manufacturing lines to fill-finish more than 500 doses per year of vaccines and other large-molecule injectable drugs using ApiJect’s prefilled injector technology, according to a news release.
The new lines will be stationed in Fareva Exelvision in Annonay, France. Machines will be purchased from Rommelag in Germany. The companies intend to start the first validation batches in June 2022, while the capacity expands ApiJect’s licensing of its manufacturing and device technology to the U.S. and Europe.
ApiJect said its blow-fill-seal (BFS) aseptic packaging process can package certain vaccines and large-molecule formulations successfully, while the company looks to expand BFS’ capabilities to additional drug products, including temperature-sensitive pharmaceuticals.
The company said that, once cleared by regulators, it will provide the necessary needle hub and other attachable components to convert finished BFS single-dose containers form the lines into easy-to-assemble, ready-to-use prefilled injectors.
“Our mission at ApiJect is to support and execute a strategy of expanded distributed fill-finish capacity in the U.S. and regionally around the world,” ApiJect CEO & Chair Jay Walker said in the release. “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.”
