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.
Authors
- Lyuyin Wang
- Xiao Liu (ORCID: https://orcid.org/0000-0001-7567-9802)
- Xinyu Lyu
- Jing Li (ORCID: https://orcid.org/0000-0001-8645-9709)
- Jun Li (ORCID: https://orcid.org/0000-0002-0148-0419)
- Kaixin Xu
- Li Yi (ORCID: https://orcid.org/0000-0002-4041-3921)
- Yue Sun
- Ping Lyu (ORCID: https://orcid.org/0009-0006-6347-2920)
Institutions
- National Medical Products Administration (CN)
- Sinovac Biotech (CN)
- Shanghai CASB Biotechnology (China) (CN)
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