CARBOGEN AMCIS Receives GMP Certification Following Successful ANSM Inspection

Pharmaceutical process development and API manufacturing company CARBOGEN AMCIS has successfully completed a first inspection by the French regulatory authority Agence nationale de sécurité du médicament et des produits de santé (ANSM) at its state-of-the-art sterile drug product manufacturing site in Saint-Beauzire, France, the company announced on March 24, 2025 (1). The inspection was part of a routine process conducted by ANSM to gauge good manufacturing practice (GMP) compliance, and as such, CARBOGEN AMCIS has been granted a GMP certificate for the French facility.

“This achievement reflects our team's dedication and hard work,” said Angie Stevens, vice president of CARBOGEN AMCIS’ Drug Product Business Unit, in a company press release (1). “With this certification, we look forward to actively supporting our customers in bringing new drugs to market and shaping a bright future together.”

The certificate permits the Saint-Beauzire facility to manufacture and release clinical and commercial sterile drug products; ANSM had granted the site authorization to manufacture, test, and release drug products upon its February 2023 opening, with the first clinical batch released in January 2024 (1).

“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, in the release (1). “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.”

“Having a cutting-edge facility dedicated to the development and manufacture sterile drug products, including to a commercial scale, strengthens our ability to offer comprehensive end-to-end services, from drug substance to drug product,” said Stephan Fritschi, CEO of CARBOGEN AMCIS, also in the release (1). “This integrated approach is a significant advantage in today’s competitive pharmaceutical landscape and provides added value for our clients.”

The Saint-Beauzire site traces its roots back to August 2020, when CARBOGEN AMCIS announced a more than CHF 100 million (now US$113 million) investment to open two new manufacturing facilities, one in its home country of Switzerland focusing on APIs, and the other, the company said at the time, located in France and concentrating on custom development and manufacturing of parenteral drug products (2).

In September 2024, Caroline Ailhas, Pharmaceutical Development director for CARBOGEN AMCIS, was among those featured in Pharmaceutical Technology®’s Trends in Formulation eBook, on the topic of prioritization of formulation strategies for temperature-sensitive biotherapeutics (3).

Ailhas explained that maintaining the structure and functionality of a molecule and defining the required duration of stabilization are the main factors challenging formulation development for temperature-sensitive molecules. The latter can vary from a few days to months, or even years. “The definition of this duration significantly impacts the formulation strategy,” Ailhas said (3).

Elsewhere in France in the first quarter of 2025, Axplora announced on February 12 a €50 million (US$52 million) investment in its site in Mourenx, with the intention of making the site a center of excellence within the company’s network for contract manufacturing of APIs and drug substances for biologics that have been FDA approved (4). That followed a previous €7.3 million (now US$7.6 million) investment, made in the Mourenx site in August 2022, to create a pilot workshop supporting a growing demand for APIs, particularly highly potent APIs to treat cancer.

CARBOGEN AMCIS said the Saint-Beauzire site completes its group portfolio, which includes seven other sites across France, Switzerland, the United Kingdom, China, and The Netherlands offering current GMP (CGMP)-compliant technologies designed to help bio/pharmaceutical companies bring next-generation medicines to market (1).

References

1. CARBOGEN AMCIS. CARBOGEN AMCIS Secures GMP Certification After Successful ANSM Inspection for its Aseptic Drug Product Manufacturing Site. Press Release. March 24, 2025.
2. CARBOGEN AMCIS. CARBOGEN AMCIS Announces Major Investments of More Than CHF 100 million in Switzerland and France. Press Release. Aug. 17, 2020.
3. Mirasol, F. Prioritizing Formulation Strategies for Temperature-Sensitive Biotherapeutics. Pharmaceutical Technology Trends in Formulation eBook September 2024.
4. Axplora. Axplora Announces €50 Million Investment in GLP-1 Manufacturing at Mourenx (France) Site. Press Release. Feb. 12, 2025.