Establishment of the first Chinese national standard for recombinant nuclease used as a process material in pharmaceutical manufacturing

The establishment of this national standard will provide a unified reference for measuring RSN activity, enhance consistency in quality control, and support the safe development and production of biopharmaceuticals (including cell and gene therapies). This standard will serve as a critical tool for regulatory evaluation and industrial applications in China. The optimized content is consistent with the copyedited version of the article, featuring clear logic and comprehensive key information.

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Publication Details

Journal
Frontiers in Bioengineering and Biotechnology
Published
2025-12-02
DOI
https://doi.org/10.3389/fbioe.2025.1695176
Primary Topic
CRISPR and Genetic Engineering
Type
article
Field-Weighted Citation Impact
0.00
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article

Establishment of the first Chinese national standard for recombinant nuclease used as a process material in pharmaceutical manufacturing

Lyuyin Wang, Xiao Liu, Xinyu Lyu, Jing Li et al.
Frontiers in Bioengineering and Biotechnology
CRISPR and Genetic Engineering
article

Establishment of the first Chinese national standard for recombinant nuclease used as a process material in pharmaceutical manufacturing

Lyuyin Wang, Xiao Liu, Xinyu Lyu, Jing Li, Jun Li, Kaixin Xu, Li Yi, Yue Sun, Ping Lyu
article en

Abstract

The establishment of this national standard will provide a unified reference for measuring RSN activity, enhance consistency in quality control, and support the safe development and production of biopharmaceuticals (including cell and gene therapies). This standard will serve as a critical tool for regulatory evaluation and industrial applications in China. The optimized content is consistent with the copyedited version of the article, featuring clear logic and comprehensive key information.

Frontiers in Bioengineering and BiotechnologyVol. 13
National Medical Products Administration (CN), Sinovac Biotech (CN), Shanghai CASB Biotechnology (China) (CN)
Openalex Percentile: Top 66%
CRISPR and Genetic Engineering
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