Best Practices for In-Use Stability and Compatibility Studies | CMC Strategy Forum North America 2024 White Paper

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Originally Published in BioProcess International 
CMC Strategy Forum North America 2024 White Paper
Best Practices for In-Use Stability and Compatibility Studies
Jing Liu, Markus Blumel, Jennifer Swisher, Félix Jules, Sarah Weiser, Jennifer Litowski, Martin Nemec, Isabella de Jong, Michael Moses, S. Anne Montgomery

In daily practice, healthcare providers frequently are required to manipulate biological drugs before and during administration. Procedures can include dilution of a drug into admixtures for infusion, short-term storage, transportation to a hospital, or exposure to new contact materials such as intravenous (IV) bags. A drug manufacturer provides instructions for those procedures based on studies of in-use stability and compatibility with administration components, simulating drug handling and hold times throughout a defined in-use period. Such studies are complex because a wide range of in-use conditions and administration components are used around the world. In addition, limited guidance is available on expected in-use stability data.