Evaluation Of Extractables And Physical Compatibility Of The Mobius® ADC Reactor Single-Use Components For ADC Manufacturing

Antibody-drug conjugates are composed of a potent and cytotoxic active pharmaceutical ingredient (API) payload attached to a monoclonal antibody (mAb) that targets specific surface antigens on cancer cells. The conjugation of the mAb to this small molecule via a linker necessitates careful handling and containment due to the toxic properties of the payload. In this process, the single-use Mobius® ADC Reactor enhances safety for operators, reduces contamination risks, and improves process efficiency, reproducibility, flexibility, and scalability.

This conjugation step often involves organic solvents, making it essential to assess compatibility with the single-use components of the reactor. The studies presented here examine the physical compatibility of these components in the Mobius® ADC Reactor and measure the level of extractables when exposed to solvents such as dimethyl sulfoxide (DMSO) and dimethyl acetamide (DMAc).