Seamless Commercial Tech Transfers In OSD Manufacturing

By Rebecca Peek, Manufacturing Science and Technology Senior Engineer, Lonza, and Laura Treche, Manufacturing Science and Technology Engineer, Lonza

The development-to-commercial transition for oral solid dosage products involves more than equipment and batch records. Getting it right requires a coordinated sequence of risk assessments, process qualification activities, and validation strategies that compound in complexity as scale increases.

This executive summary, authored by Rebecca Peek and Laura Treche of Manufacturing Science and Technology at a leading CDMO, details the foundational elements of that process: from the New Product Introduction assessment through Design of Experiments, Process Performance Qualification, and Continued Process Verification. A central case study illustrates what structured execution looks like in practice, with an initial tech transfer completing most PPQ activities within one year of contract signing and a subsequent product strength moving from contract award to PPQ batch release in approximately six months. The piece also covers the equipment capabilities required to support these processes at commercial scale.

Explore the full executive summary to see how the methodology holds up against real production timelines.