Carbogen Amcis AG has announced a series of significant investments aimed at enhancing its antibody drug conjugate (ADC) capabilities to better respond to increasing demand for ADCs in the development of highly targeted cancer treatments.
The investments include a $4 million USD clean room clinical supply facility at the Bubendorf, Switzerland site and a $950,000 USD upgrade of the sterile manufacturing area at the facility in Riom, France.
By adding on to the current High Potency facility, Carbogen Amcis is well positioned to offer its partners seamless development and manufacturing services for ADCs.
“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, CEO, CARBOGEN AMCIS and the Dishman Group.
The Bubendorf facility now features a new 100-sqm ADC clean room suite 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 1 µg/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 clean room from the rest of the building and ensures sterile operations within both compartments.
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 dry oven 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 (a) an isolator for the preparation of toxin solutions, (b) a barrier system for aseptic filtration, (c) a walk-in fume hood for handling of organic solvents, and (d) a bio-safety cabinet (classified grade C) for antibodies and ADCs.
The upgrades at our Riom, France location include 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 will expand the Grade A (ISO 5) manufacturing capability at OELs below 1 µg/m3 8h-TWA, allowing a maximum batch size up to 5’000 units (2 mL 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.
Dr. Scott Miller, head of special projects, a chemist with over 19 years industry experience in the commercialization of oncology drugs, will lead Carbogen Amcis ADC team and will support customers involved in ADC projects.
As major oncology players focus on ADCs as a high-potential opportunity in the development of targeted cancer therapies, Carbogen Amcis offers a valuable outsourcing solution for the complex process of ADC development.