Navigating the unique CMC challenges of oral anaerobic live biotherapeutics
European Pharmaceutical Review
FEBRUARY 14, 2024
As previously highlighted batch-to-batch variability in potency is expected, however, the compounding effect of method related variability in quantification makes root cause analysis even more difficult when trying to identify those parameters/conditions for process establishment/scale up. 2015; 69(1):381–403 5. 2021; 19:100306 4.
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