GMP-Grade Plasmid Production and Quality Control: a Standardized Approach from Basic Research to Clinical Application
CHEN Cheng, YI Yulan, CHENG Haizi, WU Qinbin*
As the active substance or critical raw material in cell and gene therapy products, the production process and quality control of plasmid DNA are essential for ensuring the safety and effectiveness of biologics. This article discusses the strategic importance of plasmids and their GMP (good manufacturing practice) requirements, traces the evolution of plasmids from molecular tools in basic research to industrialized products, and provides a detailed comparison of the classification and regulatory strategies for plasmids across various application scenarios under the NMPA, FDA, and EMA frameworks. Based on the practical experience from nearly one hundred GMP plasmid industrial projects completed by OBiO, the authors summarize the production processes and quality control requirements for industrial-scale plasmids. It is hoped that this work will provide valuable insights for research and development companies and researchers in the field of gene therapy, facilitating the more efficient translation of plasmids from laboratory research to clinical applications.
CN
EN