CARBOGEN AMCIS | CARBOGEN AMCIS | Saint-Beauzire

Custom formulation development and GMP sterile manuacture of liquid and lyophilized drug product

Carbogen Amcis´ purpose built GMP certified Annex 1 compliant state-of-the-art facility, opened in Q1 2023. Carbogen Amcis is dedicated to the development, sterile production, QC testing and release of injectable drug products. The facility has two fully automated filling lines and allows CARBOGEN AMCIS to collaborate with clients providing flexible access to phase appropriate scale of clinical trial material, through phase I to phase III and commercial. The facility has the capability to handle complex formulations, including a large range of APIs from biologics to highly potent compounds.

Activities

• Two production lines offering liquid and lyophilized sterile injectable drug product
• Aseptic formulation
• Handling of Highly Potent products with OEB 4+ category in both liquid and lyophilized formats.
• Drug product formulation development and analytical method development, transfer and validation
• State of the art QC laboratories to support in-process and finished product testing.
• Microbiological platform to perform bioburden, sterility and endotoxin testing
• Stability chambers to support ICH stability studies