Antibody–drug conjugates (ADCs) present unique analytical and CMC challenges due to their structural complexity, heterogeneous drug-to-antibody ratios, and sensitive linker–payload chemistries. This talk explores emerging strategies to address these hurdles across development and manufacturing. Experts will discuss advanced analytical tools, improved characterization methods, and integrated CMC approaches that support product consistency, regulatory expectations, and scalable production, ultimately accelerating the path from early development to reliable commercial manufacturing.

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.

An integrated CMC platform accelerates development of novel TMALIN-based ADCs from DNA to commercialization. TMALIN features cleavable linkers for high solubility and anti-aggregation, enabling >99% purity, a homogeneous drug-to-antibody ratio (DAR) of 8, and superior hydrophilicity, and high in vitro/in vivo stability (supporting liquid formulations). ADCs cleave extracellularly (tumor microenvironment) and intracellularly (lysosomes), with EPR (Enhanced Permeability and Retention)-enhanced tumor enrichment. The integrated CMC platform encompasses end-to-end capabilities for linker-payload, antibody, conjugation, and drug product development, manufacturing, and release.

ADC manufacturing costs run 5–10× higher than mAbs, driven by expensive drug-linkers, cytotoxic containment, and fragmented supply chains. Traditional sustainability metrics, such as PMI, miss critical factors, including energy use and Scope 2 emissions. This presentation demonstrates how early-stage digital facility modeling—combining limited process data with AI-conditioned resource databases—can construct and optimize end-to-end ADC manufacturing operations before capital is committed. Integrated optimization enables rapid comparison of alternative process configurations, establishing comprehensive cost and environmental optimization before Phase II. An ADC case study shows how strategic modeling dramatically reduces COGS, material consumption, cytotoxic waste, and carbon intensity.

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.

Antibody–drug conjugate (ADC) manufacturing is a complex, multi-step biopharmaceutical process that combines biologics production with highly potent small-molecule chemistry. ADCs are targeted cancer therapies composed of three key components: a monoclonal antibody (mAb), a cytotoxic payload, and a chemical linker that connects them. The manufacturing process must ensure safety, precision, reproducibility, and regulatory compliance due to the extreme potency of the payloads involved.

Antibody–drug conjugate development requires seamless integration of discovery, design, and translational strategy to move efficiently from the first conjugate to first-in-human studies. This talk will explore how optimized target selection, linker–payload design, and early developability assessments can improve clinical translation. Speakers will discuss preclinical models, analytical insights, and CMC considerations that help predict safety, efficacy, and manufacturability, enabling teams to build ADCs with a clearer and faster path to patients.

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.

Antibody–drug conjugates (ADCs) represent a powerful class of targeted therapeutics, combining the specificity of monoclonal antibodies with the potency of cytotoxic payloads. However, translating ADCs from discovery to commercial manufacturing requires careful optimization of conjugation chemistry, stability, and process scalability. This talk will discuss strategies to ensure both therapeutic efficacy and manufacturability of ADCs, including control of drug–antibody ratio (DAR), linker stability, analytical characterization, and robust manufacturing processes.