Carbogen Amcis AG, has made investments to augment its antibody drug conjugate (ADC) capabilities. The investments include a $4-million clean-room clinical-supply facility at its Bubendorf, Switzerland site and a $950,000-upgrade of the sterile manufacturing area at its facility in Riom, France.
The Bubendorf facility features a new 100-m2 ADC clean-room suite for 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/m3 at 8-hour time weighted average (8h-TWA).
The Grade D area of the laboratory is designated for operations, such as the preparation of reagents and buffers as well as the sterilization of production equipment by dry oven or autoclave. The Grade C area is only used for conjugation, purification, and packaging of ADC material under cGMP. This area 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 the company’s France facility include 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 5000 units (2-mL vials).
Source: Carbogen Amcis AG