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Highly Potent

High Potency API manufacturing

Four levels of Protection Cascade ensure worker safety and product quality

CARBOGEN AMCIS has state of the art facilities and controls to handle both drug substance and drug product of the highest potency, under cGMP.

Our dedicated containment facilities use containment technology, utilizing rigid isolators with Rapid Transfer Ports (RTPs) and Bag-In/Bag-Out ports, combined with airlocks, pressure cascades and access controls.

Our service portfolio starts from laboratory-scale (for process research, development and lab scale GMP production) up to large-scale manufacturing, in 2,500  liter vessels. These capabilities are underpinned with dedicated analytical and preparative purification technologies.

Highly Potent API Production at CARBOGEN AMCIS

In our business, it is essential to fulfil all the requirements of our customers, patients and also our environment.
Combining good environmental protection with high process safety and a very high GMP quality standard is a major challenge that we successfully meet every day.

Stefan - Senior Production Supervisor, Bubendorf

Safety & Product Quality

There is nothing more important to CARBOGEN AMCIS than the safety of our workers and patients. As they are the key to our business - the design of our facilities, cleaning and hygiene concepts are built with this as our guiding principle.

More than
20
years
experience in development & manufacture of HiPo APIs
Capability to handle up to category

4+

compounds (OEL 10 ng/m3)

More than
40
%
are HiPo projects
Up to
20
cm

diameter columns for HiPo chromatography

For more information
download our Company
Profile brochure