Technology Transfer In Sterile Injectables: Three Phases Towards Success

A successful technology transfer must always be underpinned by solid scoping, planning and execution. From establishing a project’s foundations to defining resources and developing schedules, through to data collection and reporting, it is key to outline all elements clearly from the outset.

This is the case for sterile injectables, which have special considerations to factor in on the path to market. From extractables and leachable analysis to lyophilization cycle robustness and process parameters, the transfer and equipment changes can have a significant effect on product formulations.

Lei Zheng and Jeny Quint from Pfizer CentreOne discuss the three phases of a technology transfer on a sterile injectable project, covering how to bridge information gaps and facilitate the path to successful regulatory filing at this fundamental stage of drug development.