CARBOGEN AMCIS, a Switzerland-based pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, has successfully obtained Good Manufacturing Practice (GMP) certification from the French regulatory authority ANSM (Agence nationale de sécurité du médicament et des produits de santé) for its sterile drug product manufacturing facility in Saint-Beauzire, France.
The certification follows a comprehensive inspection conducted from January 20-24, 2025, marking the first routine inspection by ANSM since the facility opened in February 2023. The achievement represents a significant milestone for the company's expansion into sterile drug product manufacturing.
Comprehensive Regulatory Assessment
The ANSM inspection evaluated multiple critical areas essential for aseptic drug product manufacturing. According to Julie Pagenaud, Director of Pharmaceutical Operations, Drug Products at CARBOGEN AMCIS, inspectors conducted an in-depth evaluation of the quality system with particular focus on data integrity, risk assessment procedures, technology transfer protocols, and validation strategies including Aseptic Process Simulation (APS).
The inspection also assessed the facility's compliance with EU GMP Annex 1 standards for sterile manufacturing, computer system validation protocols, and included detailed shop floor visits to evaluate cleanroom operations and adherence to aseptic processing protocols.
State-of-the-Art Manufacturing Capabilities
The Saint-Beauzire facility represents a major 60 million euro investment by CARBOGEN AMCIS. The 9,500m² site features two fully automated production lines capable of manufacturing both liquid and lyophilized drug products, supporting a wide range of therapeutic areas including highly potent compounds and advanced therapies such as antibody-drug conjugates.
"This achievement reflects our team's dedication and hard work," said Angie Stevens, Vice President, Drug Product Business Unit. "I am incredibly proud of the commitment and motivation every Saint-Beauzire employee shows. With this certification, we look forward to actively supporting our customers in bringing new drugs to market and shaping a bright future together."
The facility's flexible and versatile setup is described as unique within Europe and fully compliant with the latest EU GMP Annex 1 standards for sterile medicinal products. With over 15 years of expertise in developing injectable and liquid pharmaceutical forms, the site provides tailored solutions for pre-clinical and clinical trials and small-scale commercial manufacturing, employing approximately 130 highly skilled professionals.
Operational Challenges and Strategic Alignment
The preparation for ANSM inspection presented unique challenges as the company was simultaneously building its team, ramping up production, and ensuring regulatory compliance. Pagenaud noted that teams had to manufacture under initial authorization while preparing for the first GMP inspection, requiring careful coordination between production operations and regulatory requirements.
The inspection process highlighted the importance of technical competence among regulatory inspectors and the critical need for alignment between strategic planning and day-to-day operational execution. The ANSM inspectors' hands-on approach and technical expertise underscored the necessity of ensuring strategic plans align with shop floor operations.
Future Regulatory Expansion
CARBOGEN AMCIS plans to pursue additional regulatory approvals to strengthen global compliance and expand market reach. The company is actively working toward obtaining approvals from the FDA and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), which would enable manufacturing of commercial aseptic drug products for US and Japanese markets beyond the current clinical product manufacturing capabilities.
"The successful ANSM inspection reaffirms CARBOGEN AMCIS as a reliable partner in the drug product manufacturing market," said Helen Caddy-Leach, Head of Business Development, Drug Product. "With our extensive expertise and a state-of-the-art GMP-certified facility, we are well-positioned to support customers' drug product projects with excellence."
The company also plans investments to further expand the site and increase capacity in high-growth areas such as antibody-drug conjugates, positioning itself to meet growing demand in advanced therapeutic manufacturing.
