Carbogen Amcis earns GMP certification for French drug product manufacturing site

Carbogen Amcis has received a Good Manufacturing Practice (GMP) certification from the French regulatory authority ANSM following an inspection of its sterile drug product manufacturing site in Saint-Beauzire, France.

The inspection, conducted from Jan. 20 to Jan. 24, was the first official review by ANSM since the site began operations in February 2023. The certification permits the company to manufacture and release both clinical and commercial sterile drug products from the facility.

The Saint-Beauzire site was previously authorized by ANSM to manufacture, test, and release drug products beginning in February 2023. Carbogen Amcis released its first clinical batch in January 2024 under that initial authorization. The recent GMP certification confirms the facility’s compliance with established regulatory standards for pharmaceutical manufacturing.

The 9,500-square-meter site includes two automated production lines for liquid and lyophilized drug products. According to the company, the facility is designed to support a range of therapeutic applications, including highly potent compounds and antibody-drug conjugates, and aligns with current EU GMP Annex 1 standards for sterile medicinal products.

Carbogen Amcis operates eight sites across Europe and Asia and is known for its work in active pharmaceutical ingredient (API) development and manufacturing. The Saint-Beauzire facility expands the company’s scope to include GMP-compliant sterile drug product manufacturing at both clinical and commercial scales.