Evaluating Characterization of a Purpose-Built Single-Use ADC Conjugation Reactor: Scalability, Material Compatibility & Operational Performance
- Assessing the Mobius ADC Reactor as a single-use system developed specifically for ADC conjugation workflows
- Characterizing mixing time and temperature control across 10L to 500L reactor scales, contextualized with a GMP case study preserving ADC CQAs
- Evaluating wetted materials for tensile strength retention and extractables following exposure to 100% DMSO and DMAc via RP-HPLC and DI-GC/MS to establish a leachables dataset relevant to ADC impurity control strategies