Minimizing the impact of container closure integrity testing on gene therapy batch yield

Viral vector-based gene therapy drug product development continues to grow in importance as these therapies have demonstrated promising clinical results and gained regulatory approval for the treatment of genetic diseases, different types of cancers, and other indications. The progression of discovery and development of gene therapies is now leading to increased manufacturing capacity to support an increasing number of clinical trials.

However, small batch sizes and high cost associated with gene therapy drug product manufacture limits supply and patient access to treatments. Moreover, much of the current regulatory guidance was established based on small molecules and protein therapeutics, causing high material demand for various batch release tests and stability studies. Container closure integrity testing (CCIT) has been recognized to have a significant impact on batch yield. The purpose of this paper is to provide perspectives on CCIT strategies to minimize the impact on batch yield.

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  batch manufacture     batch yield     Container closure     container closure integrity     viral vector  
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  • Create Date 30th March 2023
  • DOI https://doi.org/10.46220/2023CGT001
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