The BPOG Leachables Working Group has recently published a Best Practice Guide for leachables. The Best Practice Guide was developed to help biopharmaceutical and vaccines manufacturers to develop science-based, robust, and efficient approaches to handling the risk of leachable compounds that is associated with increasing use of Single-Use Systems in manufacturing processes. The Best Practice Guide is composed of three parts: the risk assessment model, leachable study design, and analytical methods. This article provides insight into the application of the best practices for leachables study design by end users and includes a case study to highlight the importance of the study design.
Webinar: Single-Use Systems - Leachable Study Design for Single-Use Components
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