Track: Manufacturing and Analytical Characterization - Biomolecular - Drug Product Manufacturing and Development - Lyophilization and Drying Technologies
Category: Poster Abstract
Lyophilization: Small-Large Scale Comparability
Purpose: The study aimed to demonstrate equivalence between the pilot lyophilization unit, and the one unit located in large scale. Methods: A model formulation 5% mannitol and a practical comparison study was performed. The key parameters for lyophilization comparability were: shelf temperature mapping with minimum lyophilization load, shelf temperature mapping with full lyophilization load, comparison of critical quality attributes related to lyophilization performance. Results: Appropriate bracketing strategy was applied: comparison of the technical specification of the freeze-dryers, comparison of the downloaded digital data of the lyophilization cycle performed at pilot scale and at production scale, Freeze-dryer plot from lyophilization cycles performed in the pilot and GMP units were compared. Conclusion: The side-by-side comparison of data collected from lyophilization of small scale batches and large scale batches manufactured showed that the process remains in a state of control, confirming the scalability of the processes.
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