Demonstrating Functional Equivalence of Pilot and Production Scale Freeze-Drying of BCG.
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ABSTRACT:
SUBMITTER: Ten Have R
PROVIDER: S-EPMC4794149 | biostudies-literature | 2016
REPOSITORIES: biostudies-literature
Publications
Demonstrating Functional Equivalence of Pilot and Production Scale Freeze-Drying of BCG.
Ten Have R R Reubsaet K K van Herpen P P Kersten G G Amorij J-P JP
PloS one 20160316 3
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 scale. The duration of primary drying, the BCG survival rate, and the residual moisture content (RMC) were evaluated using two different freeze-drying protocols and were found to be independent of the fr ...[more]
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