Global contract development and manufacturing organisation (CDMO), Recipharm, has invested to expand its sterile fill and finish production capabilities at its site in Monts, France.
The manufacturing facility which specialises in the aseptic filling of pharmaceutical products, including biologics into vials and cartridges, currently has three lines for vials.
The investment will expand Recipharm's manufacturing footprint by adding a state-of-the-art, high-speed filling line that is able to fill 400 vials a minute, with the capacity for more than 100 million vials per year.
Recipharm is also in the process of implementing new cleanroom facilities and labs for microbiology and in-process controls
The new line, which has automated visual inspection and container closure integrity testing features, will have a >5 fold increased filling speed allowing temperature-sensitive biologics to be filled. Recipharm will also provide secondary packaging and labelling from the facility.
The new line will be fully commissioned in Q2 of this year and is expected to be operational for commercial production in Q3
Recipharm is also in the process of implementing new cleanroom facilities and labs for microbiology and in-process controls.
Claus Tollnick, Head of Sterile Fill & Finish Operations at Recipharm, said: "The Monts facility demonstrates our commitment as a business to meet not just present customer demand for aseptic filling, but future customer requirements, and we are investing significant sums in updating the facility and expanding its capacity. While we are bolstering our biologics capabilities, we also continue to offer strong small molecule expertise, providing a single partner to the industry for all their commercial-scale aseptic filling needs. The current experience with the Monts project suggest opportunities for further breakthroughs in productivity and line flexibility."
The site in Monts is one of Recipharm's principal sterile manufacturing facilities and has seen significant growth in recent years in the fill & finish of an mRNA vaccine. It will continue to deliver batches of COVID-19 vaccines to support vaccination programmes around the world.
The investment is part of a wider growth plan which also sees the CDMO investing in new fill and finish facilities in India and Morocco. The additional sites will complement Recipharm's existing sites in France, Germany and Italy and will be focused on securing approvals from regulators in Europe and the US.