Utilization of a Novel kLa Measurement Procedure for Bioreactor Characterization and Optimization to Assist with Compliance of Regulatory Guidelines

CGMP regulations stipulate that sampling and testing of in-process materials and drug products requires control procedures to “be established to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product”.

According to USFDA guidelines, utilizing validated processes is critical to ensuring a drug is fit for its intended use.

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