Fareva and ApiJect Systems, Corp. have announced a 10-year licensing agreement to install three Blow-Fill-Seal production lines that when operational will be able to fill-finish more than 500 million doses per year of vaccines and other large molecule injectable drugs using ApiJect’s innovative prefilled injector technology. Fareva intends to invest more than €50M (US$ 56.5M) for these three manufacturing lines, with support from the Government of France, through the “France Relance” industry initiative and the Investments for the Future Program (PIA).
The three manufacturing lines and ApiJect’s technology utilize the Blow-Fill-Seal (BFS) aseptic packaging process. BFS has demonstrated its ability to package certain vaccines and large molecule formulations, and ApiJect is helping to expand BFS’s capabilities to additional drug products, including temperature sensitive pharmaceuticals. When cleared by regulators, ApiJect will provide the necessary needle hub and other attachable components to convert finished BFS single-dose containers from these lines into easyto- assemble, ready-to-use prefilled injectors.
COVID-19 has demonstrated the strategic importance of regional pharmaceutical manufacturing to ensure strong and reliable medical supply chains. By investing in these three BFS lines and installing ApiJect technology, Fareva is helping to increase Europe’s high-speed, high-volume fill and finish capacity by potentially more than 500 million doses per year. And, the compact polyethylene-based supply chain of BFS helps establish and maintain dependable and resilient fill-finish capacity, even in the face of additional COVID-19 pandemic waves and their supply chain repercussions.
ApiJect CEO and Chair Jay Walker commented: “This commitment by Fareva, with the support of the French Government, to expand fill-finish capacity is the right step at the right time. We are proud to partner with Fareva in bringing the next generation of injection technology to global health.” Mr. Walker continued: “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. 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.” The new lines will be situated in Fareva Excelvision, located in Annonay, France, which has more than 50 years of experience manufacturing BFS containers and exporting products around the world. The BFS machines will be purchased from Rommelag in Germany. Clean rooms for these new lines will be operated in a Biosafety Level 2 (BSL2) environment, allowing them to handle most vaccines. The objective is to start the first validation batches in June 2022. In addition, this capacity expands ApiJect licensing of its BFS manufacturing and device technology to the USA and Europe.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from Pharmaceutical Outsourcing – all delivered right to your inbox!
Sign up now!