Managing Supply For Complex Biotherapeutics

By Iwan Bertholjotti, Director Commercial Development Bioconjugates, Lonza, Visp, Switzerland

Antibody-drug conjugates (ADCs) are complex bioconjugates typically used as vector-based chemotherapy, allowing the selective delivery of a nanomolar potent cytotoxic agent within a tumor. For drug substance manufacturing, the cytotoxic agent and the targeted monoclonal antibody are chemically linked via a linker. The drug product for an ADC is typically filled and lyophilized to distribute the drug in a stable form.

ADCs are complex, and their manufacturing supply chain contains five different technologies with specific asset needs: monoclonal antibody, cytotoxic payload, linker, bioconjugation and fill & finish. Even with the necessary expertise, the combination of disparate technology requirements to manufacture the five ADC components creates supply complexity. It can take years of effort to establish a reliable, high-performing logistics network to manufacture ADCs. Many companies, therefore, consider outsourcing to experienced contract development and manufacturing organizations (CDMOs) as an option to accelerate development and limit risk.