Key Considerations To Ensure A Successful Drug Substance Transfer

Scaling up to large-scale manufacture of biopharmaceutical products represents a critical stage in a life science company’s growth. However, large-scale technology transfers often present significant technical and operational challenges – challenges that many companies simply aren’t prepared to address. It is often assumed that small scale, early clinical phase manufacturing processes are robust and process steps are scalable. But manufacturing at scale requires adherence to established process parameters that are scale-dependent, as well as close examination of product characteristics and quality attributes. Limited knowledge, expertise and understanding of key and critical process parameters, process robustness, requirements for validation, analytical method transfer and validation, raw material lead times, procurement and management, and other factors associated with technology transfer and scale up can potentially lead to challenging (and expensive) delays.