Performance Characteristics Of The Mobius® ADC Reactor For Conjugation

Antibody-drug conjugates (ADCs) offer a powerful combination of potency and specificity. The monoclonal antibody (mAb) component specifically targets an antigen on the surface of cancer cells to precisely deliver the highly cytotoxic payload to the tumor. As the development and approval of ADCs continue to accelerate, the modality is becoming a critical drug class in many biopharmaceutical pipelines.

In an ADC, the mAb is connected to the payload through a linker that influences the stability of the ADC in circulation and controls the release of the payload. A key phase in ADC production is conjugation, where the linker, attached to the payload, is attached to the mAb. Given the high potency and toxicity of the payload, this step must be carefully managed to ensure proper containment and safe handling. Traditionally, this process has been carried out using glass or stainless-steel vessels or mixers. However, the use of single-use technologies is becoming more widespread, offering advantages such as reproducibility, flexibility, ease of scalability, reduced contamination risk, and lower costs. These systems also save time by streamlining setup, cleaning validation, and cleaning processes.

This white paper presents a sequence of studies evaluating the Mobius® ADC Reactor's mixing performance during the conjugation step utilizing a model fluid. The studies assessed factors such as heating and cooling times, acid/base blending, and the impact of various mixing speeds for reactor sizes of 10 L, 100 L, and 500 L.