CARBOGEN AMCIS Secures GMP Certification for Saint-Beauzire Sterile Drug Facility

• CARBOGEN AMCIS has successfully completed its first ANSM inspection, securing a GMP certificate for its sterile drug product manufacturing site in Saint-Beauzire, France.

• The €60 million facility, opened in early 2023, supports clinical and commercial sterile drug production, including antibody-drug conjugates and highly potent compounds.

CARBOGEN AMCIS has achieved a key milestone with the successful completion of its first inspection by the French regulatory authority, ANSM (Agence nationale de sécurité du médicament et des produits de santé). Conducted from January 20 to January 24, the inspection resulted in Good Manufacturing Practice (GMP) certification for the company’s sterile drug product manufacturing site in Saint-Beauzire, France. This certification enables the production and release of clinical and commercial sterile drug products.

Opened in February 2023, the €60 million Saint-Beauzire facility features two fully automated production lines for liquid and lyophilized drug products. The 9,500m² site supports a diverse range of therapeutic applications, including advanced therapies such as antibody-drug conjugates and highly potent compounds. The facility is designed to meet the latest EU GMP Annex 1 standards for sterile medicinal products.

Since its authorization in February 2023, the site has been operating under regulatory approval, with its first clinical batch released in January 2024. “This achievement reflects our team’s dedication and hard work,” said Angie Stevens, Vice President, Drug Product Business Unit. “With this certification, we look forward to actively supporting our customers in bringing new drugs to market.”

Helen Caddy-Leach, Head of Business Development, Drug Product, emphasized the significance of the certification, stating that it reinforces CARBOGEN AMCIS as a trusted partner in drug product manufacturing. She highlighted the company’s expertise and advanced facility as key factors in delivering high-quality support for customers’ drug product projects.

The new site further enhances CARBOGEN AMCIS’ existing API manufacturing capabilities, strengthening its position as a full-service provider in drug development and production. “Having a dedicated facility for sterile drug products, including commercial-scale manufacturing, enables us to provide seamless, end-to-end services from drug substance to drug product,” said Stephan Fritschi, CEO of CARBOGEN AMCIS. “This integrated approach offers substantial advantages in today’s competitive pharmaceutical landscape and delivers added value for our clients.”

The new facility complements CARBOGEN AMCIS’ long-standing expertise in API manufacturing, reinforcing its position as a full-service provider for drug development and production. The company’s eight global sites, spanning Switzerland, France, the UK, China, and the Netherlands, support cGMP-compliant pharmaceutical innovations. The Saint-Beauzire site plays a key role in expanding the group’s capabilities in sterile drug product development and manufacturing.