CARBOGEN AMCIS provides state-of-the-art containment services. All facilities operate to current Good Manufacturing Practice (cGMP) and can produce material for preclinical testing, clinical trials and commercial use.
In 2008 and 2011 the US Food and Drug Administration (FDA) performed a successful PAI audit of CARBOGEN AMCIS' containment facilities concluding without any "483 observations".
All CARBOGEN AMCIS containment facilities are designed based on a containment concept utilizing the "split-butterfly valve" and barrier isolation technology as well as a strict zone concept with pressure cascades, airlocks and access controls. This allows the safe handling of highly-potent compounds of all categories including cytostatics / cytotoxics.
CARBOGEN AMCIS offers services starting from laboratory scale for process research and development purposes up to large scale manufacturing on 1'600 L including category IV compounds (OEL < 1 µg/m³), the highest category in the CARBOGEN AMCIS categorization system. In addition to our process research and manufacturing services for the fast supply of highly-potent APIs, CARBOGEN AMCIS offers formulation services for highly-potent drug products and GMP aseptic production of parenteral drugs, including cytostatics / cytotoxics.
To support the Active Pharmaceutical Ingredient (API) development process through all stages, a variety of high-containment analytical and purification capabilities complement the chemistry service portfolio.