Antibody-Drug Conjugates

Antibody-Drug Conjugates Partner

Mabion approaches ADC development as a configurable platform built around the biology of each molecule and indication. Key design elements may include target antigen selection, antibody scaffold development, linker chemistry, payload class, conjugation strategy, drug-to-antibody ratio profile, stability, potency, and analytical control.

Mabion’s Antibody-Drug Conjugates platform including cooperation with:

• KriSan Biotech Co., Ltd.
• Celon Pharma S.A.

Safety parameters are critical for ADC programs because even small differences in conjugation profile, aggregation, linker stability, free payload, or drug-to-antibody ratio (DAR) distribution may affect performance and regulatory readiness. Mabion’s expertise in monoclonal antibody development and quality-by-design process development provides a strong foundation for complex bioconjugates, including future-compatible radioimmunoconjugates.

Antibody-Drug Conjugates Process Development

ADCs are complex biopharmaceuticals that integrate the specificity of monoclonal antibodies with the potency of highly active cytotoxic payloads, enabling selective delivery of therapeutics to cancer cells while minimizing systemic toxicity.

Mabion has been actively involved in the development of Antibody-Drug Conjugates through collaborative projects with innovative biotechnology companies. These partnerships combine Mabion’s expertise in biologics development and manufacturing with specialized ADC technologies to support the advancement of next-generation targeted therapies.

The ADC development process begins with the selection and optimization of a suitable monoclonal antibody that recognizes a specific tumor-associated antigen. During this stage, cell line development, upstream and downstream process development, and comprehensive drug characterization are performed to ensure high product quality and manufacturability. Once the antibody candidate is established, it is conjugated with a cytotoxic payload through a carefully designed chemical linker. Linker-payload selection is critical, as it determines the stability of the ADC in circulation, the controlled release of the drug at the target site, and ultimately the therapeutic efficacy and safety profile. Conjugation process development focuses on achieving the desired DAR, minimizing product heterogeneity, and ensuring reproducible manufacturing performance.

Following conjugation, ADC candidates undergo extensive analytics and process characterization to evaluate critical quality attributes, including DAR distribution, aggregation levels, free payload content, stability, and biological activity. Process development activities are complemented by formulation development, scale-up studies, and preparation for GMP manufacturing.