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Fareva plans to use blow-fill-seal equipment and ApiJect’s prefilled injector technology to create fill/finish capacity in France.
Fareva and ApiJect Systems announced a 10-year licensing agreement to install three blow-fill-seal (BFS) production lines that, once 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 prefilled injector technology, the companies said in a Dec. 9, 2021 press release. Fareva intends to invest more than €50 million (US$ 56.5 million) 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 company reported in the press release.
The BFS process has been demonstrated to be able 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, according to the release. 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 ready-to-use prefilled injectors.
The new lines will be in Fareva Excelvision’s facility in Annonay, France, which has more than 50 years of experience manufacturing BFS containers. The BFS machines will be purchased from Rommelag in Germany. Cleanrooms for these new lines will be operated in a Biosafety Level 2 (BSL2) environment, allowing them to handle most vaccines, according to the press release. First validation batches are expected to be manufactured in June 2022. According to the press release, the expansion will create 150 jobs.
“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,” said ApiJect CEO and Chair Jay Walker in the press release. “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.”
“This ambitious 50 million euros project will strengthen our healthcare industry in France and shows that innovation is not only in the vaccines but also stands in the injection devices. It is also the reason why we have agreed to support it with the France Relance program,” said Agnès Pannier-Runacher, Minister Delegate for the Industry, in the press release.