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Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies

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Description

Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies1. Scope 1. 1 This guide outlines the parameters to consider when designing in vitro tests to assess the potential impact of a delivery device on a cellular product being dispensed. This guide does not provide specific protocols, but rather suggests what should be considered the minimum characterization necessary to assess device cytocompatibility. Topics discussed include selecting an appropriate cell line(s), cell physiology parameters to measure,

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