Tech Transfer Strategies For Monoclonal Antibody Drug Products In Late-Phase Clinical And Commercial Launch

By Shawn Cain, SVP of Development and Manufacturing, PCI

Moving a monoclonal antibody (mAb) drug from late-stage clinical trials to full-scale commercial manufacturing is a crucial step in drug development. This process, known as technology transfer (tech transfer), involves systematically moving all development and manufacturing information from a development site to a commercial production facility. For a CDMO, this isn't just about copying a process; it’s a complex, coordinated effort to ensure the process is robust, scalable, compliant with regulations, and ready for the global market.

At this phase, the focus shifts from making small batches for clinical trials to creating a reproducible, commercially viable process that can produce consistent, high-quality drug product at a large scale. This requires a strategic approach to several key areas.

Scaling up an mAb process presents unique challenges because of the inherent complexity of these drugs, including their structure and formulation requirements. Key considerations during this transition include purification efficiency, formulation stability, and aseptic fill/finish operations.