How Osmolality Testing Ensures Quality by Design

Osmolality has long been viewed as a release specification for final drug formulations. However, osmolality could and should be implemented for many process checkpoints throughout the bioprocessing workflow. For instance, the health and yield of upstream cell culture can be effectively monitored with osmolality testing. In downstream processing, osmolality can serve as a sensitive and reliable process control for buffer exchange as well as for the monitoring of protein purification. BioPharm International recently sat down with Kristeena Wright, PhD, Application Scientist at Advanced Instruments, to discuss the value of osmolality testing and how biopharmaceutical manufacturers could benefit from increasing its implementation.

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