This presentation addresses scalable process design, analytical control, and regulatory readiness, helping teams bridge early development to launch. By integrating quality by design, robust supply strategies, and platform approaches, the program reduces technical uncertainty, accelerates timelines, and improves reproducibility, enabling confident commercialization of complex, high-value therapeutics across global networks and evolving modalities worldwide adoption.

Scaling antibody–drug conjugate (ADC) manufacturing requires more than capacity expansion—it demands disciplined control of quality and safety risks that directly affect clinical outcomes. Minor process deviations can alter drug–antibody ratio, free payload, and stability, influencing exposure, toxicity, and efficacy. This presentation outlines a holistic manufacturing and safety strategy that integrates process design, quality controls, and occupational safety. By aligning CMC and EHS systems with clinical risk drivers, organizations can achieve predictable performance, regulatory confidence, and a successful transition from development to commercial supply.

Cysteine-engineered mAbs (ThiomAbs) enable site-specific ADC conjugation but introduce reactive free thiols that drive variable Cys/GSH capping with charge heterogeneity and uncapped free thiol with stability risk. Here we developed an on-column capping strategy during affinity chromatography by immobilizing antibodies and selectively masking engineered thiols under optimized redox conditions to reduce capping heterogeneity at engineered cysteines, thereby reducing analytical complexity and improving process control.