Liu, Jing, Bluemel, Markus, Swisher, Jennifer, Jules, Felix, de Jong, Isabella, Litowski, Jennifer, Moses, Michael, Weiser, Sarah, Ibrahim, Basma, Clark, Nicholas and Hu, Qingyan (2025) Securing Patient Well-Being Best Practices for In-Use Stability and Compatibility Studies. BioProcess international., 23 (4). pp. 19-26.

Abstract

In daily practice, healthcare providers and patients 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 bags. A drug manufacturer provides such instructions for use 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 globally. In addition, regulators provide only limited guidance on expected in-use stability data.
There is significant interest and value in capturing best practices for in-use stability and compatibility studies. To advance this goal, we summarize herein the findings of the CASSS chemistry, manufacturing, and controls (CMC) Strategy Forum, which was held on 22 January 2024 in Washington, DC. The forum, entitled “Securing Patient Well-being: Best Practices for In-Use Stability and Compatibility Studies,” addressed classic biological products and emerging trends. The forum was structured into four 90-minute workshops. Each workshop began with two presentations, followed by a discussion with the presenters and additional panel members:
• Workshop 1: Established Best Practices for In-Use Stability Study Design and Testing
• Workshop 2: Microbial In-Use Studies and Closed System Transfer Devices
• Workshop 3: Product In-Use: Meeting Patient and User Needs
• Workshop 4: Emerging Trends in Compatibility and In-Use Stability Studies

Item Type:	Article
Keywords:	in-use stability, compatibility
Date Deposited:	03 May 2025 00:45
Last Modified:	03 May 2025 00:45
URI:	https://oak.novartis.com/id/eprint/55184