In-Use Stability Testing Protocols for Biologics
In-Use Stability Testing Protocols for Biologics Best Practices for In-Use Stability Testing of Biologics In-use stability testing is a critical component of biopharmaceutical product development, particularly for formulations that are reconstituted before use, presented in multi-dose vials, or administered through infusion devices. These studies simulate real-world handling conditions post-opening or reconstitution to ensure product quality,…
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