From endonuclease comparability challenges to harmonized activity testing: USP 〈89.3〉 General Chapter for endonucleases and its impact on the comparison of Denarase and Benzonase

The comparability of endonucleases is essential to secure supply chains, including dual sourcing strategies. To address this long-standing comparability challenge, the USP (United States Pharmacopeia) has released the General Chapter 〈89.3〉 Endonuclease (Serratia marcescens), introducing a harmonized framework for endonuclease activity determination. This marks an important step toward standardization of a critical ancillary material used in cell and gene therapy (CGT) manufacturing. In this study, the Denarase^® activity release test developed by Kerry (formerly c-LEcta) for its Denarase^® product is used, to compare activities of Denarase^® and Benzonase^®. By applying the Denarase^® activity release assay test protocol to both enzymes, the correspondence of these results to the respective product's CoA values was evaluated.

Benzonase Nuclease is a registered trademark of Merck KGaA.

Resource details:

Resource type: Scientific Poster
Page count: 1
Read time: 4 mins