Carbogen Amcis AG has made several investments to enhance its antibody drug conjugate (ADC) capabilities for the development of highly targeted cancer treatments. The investments include a $4 million clean room clinical supply facility at its Bubendorf, Switzerland site, and a $950,000 upgrade of its sterile manufacturing area at the facility in Riom, France.
“The new targeted cancer treatments, such as Adcetris, Kadcyla and Mylotarg, have fueled a growing demand for ADCs and we made the decision to expand our ADC service offer to support customers in the development of next-generation cancer treatments. We have taken into account customer feedback and market dynamics and are confident that our enhanced infrastructure will enable us to provide our partners in the pharmaceutical industry a needed resource in drug development,” said Mark C. Griffiths, chief executive officer, Carbogen Amcis AG and the Dishman Group.
The Bubendorf facility features a new 100-sqm ADC clean room suite dedicated to the development and production of ADC clinical material under cGMP, and contains grade D and grade C areas to allow aseptic and safe handling of highly potent material at occupational exposure limit values (OELs) below 1 µg/m3at 8-hour time weighted average (8h TWA).
The grade D area of the lab is dedicated to operations such as the preparation of reagents and buffers as well as the sterilization of production equipment by dryoven or autoclave. The segregated grade C area is exclusively used for the conjugation, the purification, and the packaging of ADC material under cGMP and features an isolator for the preparation of toxin solutions, a barrier system for aseptic filtration, a walk-in fume hood for handling of organic solvents, and a bio-safety cabinet for antibodies and ADCs.
The Riom facility now includes the implementation of a new vaporized hydrogen peroxide (VHP) disinfection system and the installation of two new aseptic filling isolators operating under nitrogen atmosphere and at regulated temperature, which expands the Grade A (ISO 5) manufacturing capability at OELs below 1 µg/m38h TWA, allowing a maximum batch size of 5,000 units (2 mL vials).