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Endonuclease Evaluation for Viral Vector Manufacturing: Process Impurity Control Case Study

Effective DNA clearance is essential in viral vector manufacturing to ensure product purity, regulatory compliance, and patient safety. As demand for AAV and LVV-based cell and gene therapies grows, biopharmaceuticals and CDMOs must adopt scalable, high-performing endonucleases. 

This study evaluated Roche’s EndoCleave endonuclease against commercial benchmarks using a transient transfection platform with suspension HEK293 cells. Two Proof-of-Concept studies assessed performance across key process parameters—enzyme concentration, incubation time, temperature, and salt conditions—representative of AAV and LVV production. 

EndoCleave consistently matched the performance of commercially available endonuclease in reducing host cell and plasmid DNA without impacting viral titers. Its activity remained robust under varying conditions, confirming suitability for both AAV and LVV workflows. 

These results suggest EndoCleave as a reliable, scalable solution for removing nucleic acid in GMP-ready vector manufacturing environments and could also be a potential cost-effective solution.

Speaker:

Dr. Soodeh Baghaee-Ravari – Director of Process Development, Genezen

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