CARBOGEN AMCIS provides services for the development and manufacture of highly potent drug sub-stances (API) and drug products applying state-of-the-art containment technologies. All facilities operate to current Good Manufacturing Practice (cGMP) and can produce material for preclinical testing, clinical trials and commercial use. Our manufacturing sites are regularly inspected by the US Food and Drug Administration (FDA) and local regulatory bodies.
CARBOGEN AMCIS containment facilities are designed based on a containment concept utilizing barrier isolation technology and Rapid Transfer Ports (RTPs) as well as a strict zone concept with pressure cascades, airlocks and access controls. This allows the safe handling of highly potent compounds including cytotoxics. The highest category in CARBOGEN AMCIS' categorization system is category 4 with an occupational exposure limit (OEL) range of 1 - 0.05 µg/m³.
However, recent containment testing performed according to ISPE's SMEPAC-guideline, has shown that CARBOGEN AMCIS can safely handle ultra-potent toxins with an OEL as low as 0.01 µg/m³ (10 ng/m³) 8hr-TWA. : (ISPE = International Society for Pharmaceutical Engineering, SMEPAC = Standardised Measurement of Equipment Particulate Airborne Concentration, TWA = Time Weighted Average).
CARBOGEN AMCIS offers services starting from laboratory scale for process research and development purposes up to large scale manufacturing in 1'600 L vessels. To support the API development process through all stages, a variety of high-containment analytical and purification capabilities complements the chemistry service portfolio. CARBOGEN AMCIS can also manage conjugation projects for Antibody Drug Conjugates (ADCs) from its newly built clean room at the Bubendorf site. In addition to our process re-search and manufacturing services for the fast supply of highly potent APIs, CARBOGEN AMCIS has in its service portfolio formulation services for drug products and GMP aseptic production of parenteral drugs in Grade A (ISO 4.8) areas.