Changing and optimizing a process such as a freeze drying cycle during a technology transfer for finished dosage forms (FDF) can not only improve efficiency, reduce costs, enhance product quality but can often also profit from innovations and advanced technologies that the new site has to offer. Furthermore, there are new possibilities to adapt the lyophilization cycle to the new plant and to obtain a production slot more easily with a modern, efficient (cost and time-saving) lyophilization cycle that is optimally adapted to the product thanks to new technologies.
At ProJect Pharmaceutics CRO we are experts in lyophilization process development for injectable drug products and have installed advanced lyophilization technologies on site. By means of a very systematic (algorithm-based) approach we explore very quickly in up to five (!) lyophilization cycles max. the ideal freezing, sublimation and drying parameters. Challenging the final cycle program in a process robustness testing panel will evaluate the design space of the critical process parameters. Cycles optimized this way in terms of robustness and efficiency enable a very smooth tech transfer: with a validated design space and a robustly tested lyophilization cycle, the number of engineering batches needed during technology transfer can potentially be reduced.
If you would like to benefit fully from the switch to a new production site with an optimized, modern lyophilization cycle, please contact us
