ADVERTORIAL
GMP-certified excellence in sterile manufacturing
CARBOGEN AMCIS’ Saint-Beauzire site secures ANSM certification and sets a new standard in parenteral drug production, reinforcing its position as a trusted CDMO partner with state-of-the-art infrastructure and a commitment to quality
In January 2025, CARBOGEN AMCIS’ Saint-Beauzire facility in France successfully completed its first Good Manufacturing Practice( GMP) inspection by the French health authority, ANSM( Agence Nationale de Sécurité du Médicament et des produits de santé). This significant milestone confirms the site’ s compliance with EU GMP standards for sterile manufacturing and grants full certification for the manufacture and release of clinical and commercial drug products.
“ This achievement reflects our team ' s dedication and hard work,” said Angie Stevens, vice president of the Drug Product business unit.“ We’ re proud to now support customers with a fully certified, cutting-edge facility built around quality, flexibility and patient safety.”
A state-of-the-art European facility
Located near Clermont-Ferrand, the 9,500 m 2 Saint-Beauzire site opened in early 2023 following a € 60 million investment. It features two advanced production lines housed within fully automated isolators, supporting both liquid and lyophilised formats and designed to handle sensitive and highly potent compounds. The site’ s infrastructure was built from the ground up to meet the latest Annex 1 requirements for sterile drug product manufacturing.
The facility offers versatile packaging options, from vials to future formats like prefilled syringes and cartridges. Its high-containment capabilities( OEB Categories 1 to 4 +) and specialised environments for low-temperature and inert-atmosphere processing make it a premier destination for developing complex formulations.
Supporting innovation & scale
Saint-Beauzire plays a central role in CARBOGEN AMCIS’ end-to-end service offering. Alongside in-house formulation development, the site provides aseptic filling, freeze-drying, quality control and analytical support, all under one roof. Its capabilities span from preclinical and clinical trial support to small-scale commercial manufacturing.
With a growing team of over 130 skilled professionals and purposebuilt R & D labs, the site ensures rapid, integrated solutions tailored to each customer’ s needs. Whether supporting early-phase biologics or scaling up high-potency oncology products, Saint- Beauzire combines scientific innovation with operational excellence.
An integrated CDMO advantage
“ This certification strengthens our offering as a true end-to-end CDMO,” said Stephan Fritschi, CEO of CARBOGEN AMCIS.“ It complements our drug substance expertise and gives our clients a strategic advantage in accelerating their path to market.”
Saint-Beauzire is not just a manufacturing site— it’ s a symbol of CARBOGEN AMCIS’ long-term commitment to advancing sterile drug product capabilities and driving global pharmaceutical innovation. ●
WATCH THE SITE IN ACTION
MAY / JUN 2025 SPECCHEMONLINE. COM
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