Includes a cleanroom clinical supply facility in Switzerland and a sterile area upgrade in France
Switzerland-based Carbogen Amcis, a division of the Indian Dishman Group, has made significant investments to enhance its antibody drug conjugate (ADC) capabilities to respond to increasing demand for ADCs in the development of cancer drugs.
The firm has spent US$4m on a cleanroom clinical supply facility at Bubendorf, Switzerland, and $950,000 to upgrade the sterile manufacturing area at its plant in Riom, France.
'The new targeted cancer treatments, such as Adcetris, Kadcyla and Mylotarg, have fuelled 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,' said Mark Griffiths, CEO of Carbogen Amcis and the Dishman Group.
The new 100m2 ADC cleanroom suite at Bubendorf is dedicated to the development and production of ADC clinical material under current good manufacturing practices (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 1µg/m3 at 8-hour time weighted average (8h TWA). A system of pressure cascade and air locks for material and personnel fully segregates both areas of the cleanroom from the rest of the building and ensures sterile operations within both compartments.
We made the decision to expand our ADC service offer to support customers in the development of next-generation cancer treatments
The grade D area of the lab is dedicated to operations such as the preparation of reagents and buffers as well as the sterilisation of production equipment by dry oven or autoclave. The segregated grade C area is exclusively used for the conjugation, purification, and 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 (classified grade C) for antibodies and ADCs.The upgrades at Riom include the implementation of a new vaporised hydrogen peroxide (VHP) disinfection system and the installation of two new aseptic filling isolators operating under nitrogen atmosphere and at regulated temperature, which will expand the Grade A (ISO 5) manufacturing capability at OELs below 1µg/m3 8h TWA, allowing a maximum batch size up to 5,000 units (2mL vials).
'In addition to strengthening our ADC capabilities, over the past 12 months, we have built a cross-functional team with expertise in chemistry, biochemistry and biology that is well equipped to support our customers’ cancer drug development programmes,' added Griffiths.
Scott Miller, Head of Special Projects, a chemist with over 19 years industry experience in the commercialisation of oncology drugs, will lead the ADC team at Carbogen Amcis and will support customers involved in ADC projects.