Establishment of the first Chinese national standard for recombinant nuclease used as a process material in pharmaceutical manufacturing
Year: 2025
Type: article
Language: en
Topic: CRISPR and Genetic Engineering
Authors and affiliations:
raw_author_name: Lyuyin Wang
raw_affiliation_strings: National Institutes for Food and Drug Control, State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, Beijing, China
raw_author_name: Yue Sun
raw_affiliation_strings: National Institutes for Food and Drug Control, State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, Beijing, China
raw_author_name: Kaixin Xu
raw_affiliation_strings: National Institutes for Food and Drug Control, State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, Beijing, China
raw_author_name: Xinyue Hu
raw_affiliation_strings: National Institutes for Food and Drug Control, State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, Beijing, China
raw_author_name: Yi Li
raw_affiliation_strings: National Institutes for Food and Drug Control, State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, Beijing, China
raw_author_name: Ping Lyu
raw_affiliation_strings: National Institutes for Food and Drug Control, State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, Beijing, China
raw_author_name: Xiao Liu
raw_affiliation_strings: Shanghai Yaxin Biotechnology Limited Company, Shanghai, China
raw_author_name: Jun Li
raw_affiliation_strings: National Institutes for Food and Drug Control, State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, Beijing, China
Sinovac Biotech Co., Ltd., Beijing, China
raw_author_name: Jun Li
raw_affiliation_strings: National Institutes for Food and Drug Control, State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, Beijing, China
Sinovac Biotech Co., Ltd., Beijing, China
raw_author_name: Jing Li
raw_affiliation_strings: National Institutes for Food and Drug Control, State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, Beijing, China
Sinovac Biotech Co., Ltd., Beijing, China
raw_author_name: Jing Li
raw_affiliation_strings: National Institutes for Food and Drug Control, State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, Beijing, China
Sinovac Biotech Co., Ltd., Beijing, China