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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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