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HIGHLY POTENT API SERVICES

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 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.

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.



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