Standardizing Endonuclease Activity: What You Need to Know About USP <89.3>

Endonuclease (Serratia marcescens) is a critical ancillary material used to degrade host cell nucleic acids and remove residual DNA during biopharmaceutical and cell & gene therapy manufacturing. As regulatory expectations for ancillary material qualification continue to rise, the demand for standardized, activity-based analytical methods has become increasingly important. To support assay consistency in Endonuclease material qualification programs, USP has proposed General Chapter <89.3>, featuring a validated enzymatic activity method and a highly characterized qualitative Reference Standard (Endonuclease S. marcescens, Catalog No. 1235470), evaluated through collaborative studies conducted by USP and collaborating laboratories. Eurofins BioPharma Product Testing has implemented this standardized method and validated that the method demonstrates fitness-for-purpose and supports phase-appropriate control strategies. The method delivers consistent, reproducible results suitable for lot release and comparability assessments.

In this presentation, we will discuss:

• The role of Endonuclease in biopharmaceutical and cell/gene therapy manufacturing.
• Regulatory drivers for ancillary material qualification and phase-appropriate control strategies.
• Details of USP General Chapter <89.3> and its significance in standardizing endonuclease activity testing.
• How the validated spectrophotometric assay quantifies endonuclease activity via DNA substrate degradation with absorbance at 260 nm, enabling calculation of enzymatic activity and specific activity.

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