Week's news analysis

Fareva and ApiJect sign a licensing agreement

By Editors - 09 December 2021
Fareva Excelvision, Annonay-France /DR

Fareva and ApiJect Systems, Corp. announced a 10-year license agreement for the production of single-dose pre-filled vaccine injections using ApiJect's licensed pre-filled injector technology.

Fareva intends to invest more than 50 million euros (US $ 56.5 million) for the installation of three Blow-Fill-Seal production lines.

This project is receiving support from the French government, through the "France Relance" industrial initiative and the Investments for the Future (PIA) program. "France relance" aims to finance research and development projects, and to support the industrialization of health products. Designed as a lever to increase French industrial capacity in health products intended to fight the pandemic, it provides immediate responses to fight against the spread of COVID-19 and its variants. "France Relance" had announced, on November 29, 7 CDMOs laureates.

READ 7 CDMOs are laureates of France Relance

The new lines will be located 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. The three new BFS lines, implemented by FAREVA, will be able to produce up to 500 million doses per year of vaccines and other large molecule injectable drugs.

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 easy-to-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.

"This commitment by Fareva, with the support of the French Government, to expand fill-finish capacity is the right step at the right time. It is desperately needed for the continued battle against COVID in France, Europe and around the world, and to add to the necessary capacity to deal with possible future bio-emergencies" said ApiJect CEO and Chair Jay Walker

Fareva, a family-owned company, whose strength lies in its financial independence, is one of the world's leading CDMOs in the pharmaceuticals, cosmetics, make-up, and industrial and homecare fields. Fareva operates in 12 countries with 42 factories and employs more than 13 000 employees with annual revenues reaching € 1.8 billion in 2020.

RELATED Injectable innovations - Apiject versus Euroject

Go to Top