CARBOGEN AMCIS has announced that it has successfully secured GMP Certification at its sterile drug product manufacturing site in Saint-Beauzire, France. The French regularity authority ANSM (Agence nationale de sécurité du médicament et des produits de santé) conducted its first inspection from the 20th to the 24th of January, earlier this year.
CARBOGEN AMCIS
This inspection is a routine process conducted by the ANSM as it ensures the company is complying with Good Manufacturing Practices (GMP). Following the successful completion of the inspection, the pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company received its GMP certificate for its facility, which opened in February 2023.
Having earned the certificate, CARBOGEN AMCIS can manufacture and release clinical and commercial sterile drug products. The company had previously received authorisation from the ANSM to manufacture, test, and release drug products since it opened in 2023.
“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.”
About the Saint-Beauzire facility
Opened in 2023, the facility symbolises the CARBOGEN AMCIS’ commitment to improving sterile drug product manufacturing capabilities. The 9,500m² site features two fully automated production lines for liquid and lyophilized drug products, supporting various therapeutic areas like highly potent compounds and advanced therapies including antibody-drug conjugates. Boasting a flexible and versatile setup, the facility is unique in Europe and is fully compliant with the latest EU GMP Annex 1 standards for sterile medicinal products.
The company’s Saint-Beauzire site provides tailored solutions for both pre-clinical and clinical trials as well as small-scale commercial manufacturing. Finally, the facility completes the Group’s portfolio and is integral to the company's production chain. By opening the new site, the Group has expanded its capacity to develop and manufacture advanced sterile drug products.
“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.”
Stephan Fritschi, CEO of CARBOGEN AMCIS, concluded, “Having a cutting-edge facility dedicated to the development and manufacture of sterile drug products, including on a commercial scale, strengthens our ability to offer comprehensive end-to-end services, from drug substance to drug product. This integrated approach is a significant advantage in today’s competitive pharmaceutical landscape and provides added value for our clients.”