Highly Potent API Services

The Dishman Group offers unparalleled capability in scale-up, development and commercial manufacture of highly potent compounds. These highly potent API services are offered under the CARBOGEN AMCIS business.

The Dishman Group provides state-of-the-art containment services. All of our 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 our Swiss containment facilities concluding without any “483 observations”.

All of our 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.

We offer services starting from laboratory scale for process research and development purposes up to large scale manufacturing on 1600L scale including category IV compounds (OEL < 1µg/m³), the highest category in our 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.