Extractables and Leachables in Gene and Cell Therapies

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Extractables and Leachables in Gene and Cell Therapies

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Extractables and Leachables in Gene and Cell Therapies

This article critically examines the safety of single-use (SU) systems in cell and gene therapy applications, focusing on the low risk posed by process equipment-related leachables (PERLs). It demonstrates how modeling can predict PERL concentrations and their interaction with therapeutic cells, and uses cell-painting assays to assess the impact of extractables on human cells, showing how SU systems can support safety standards in these therapies.

Key Takeaways

PERLs from SU systems are low risk in gene and cell therapy applications.
Modeling is a valuable tool for estimating PERL presence and cell interactions.
Cell-painting assays support the safety of SU systems, showing minimal impact on human cells.

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Extractables and Leachables in Gene and Cell Therapies

Extractables and Leachables in Gene and Cell Therapies

Key Takeaways

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