Lyophilization: cycle robustness and process tolerances, transfer
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During the past 10-15 years, close attention has been paid to the development of optimal lyophilization cycles for different types of pharmaceuticals1-4. Recent advances in process control, such as the Smart Freeze-DryerTM technology or similar approaches, [5-7] make cycle development a routine procedure. The attention of many researchers has shifted to the aspects of cycle transfer and scale up that still require significant investment in understanding the differences in lyophilization processes between laboratory and commercial dryers [8-14].
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