The Art And Science Of Getting Tech Transfer Right First Time

By Dipak Gordhan and Nathan Collingwood

Technology transfer in drug development is far more than a simple documentation exchange; it is a complex, knowledge-driven transition that connects formulation design directly to manufacturing scale . Achieving a successful scale-up requires a deep understanding of product behavior, identifying critical process parameters, and adapting small-scale laboratory steps—such as spray drying—to meet large-scale GMP environments without compromising quality.

A successful transition relies heavily on early planning and transparent knowledge sharing . Integrating scale-up considerations during initial development helps identify potential raw material or manufacturing hurdles before they disrupt project timelines . Additionally, leveraging modern statistical tools like Design of Experiments (DoE) creates a data-driven framework to systematically manage risk and establish long-term process controls . By pairing well-defined frameworks with experienced cross-functional teams, organizations can safeguard critical process insights, de-risk manufacturing, and reliably progress novel therapies into clinical trial production.