Demonstrating Functional Equivalence of Pilot and Production Scale Freeze-Drying of BCG.

Process analytical technology (PAT)-tools were used to monitor freeze-drying of Bacille Calmette-Guérin (BCG) at pilot and production scale. Among the evaluated PAT-tools, there is the novel use of the vacuum valve open/close frequency for determining the endpoint of primary drying at production sca...

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Bibliographic Details
Main Authors: R Ten Have, K Reubsaet, P van Herpen, G Kersten, J-P Amorij
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2016-01-01
Series:PLoS ONE
Online Access:http://europepmc.org/articles/PMC4794149?pdf=render