In recent years, the domestic gene therapy industry has developed rapidly, and innovative gene therapy products are emerging constantly. How to effectively control the quality of such products has become a highly concerned issue in the industry. This article draws inspiration from relatively mature, effective, and practical methods in the field of quality control of gene therapy products. Taking recombinant adeno-associated virus gene therapy products as an example, starting from the selection of testing items and methods, precautions, and formulation of quality standards, it elaborates on their quality control inspection items and related technical requirements. We hope this article can provide reference for practitioners to conduct quality control research on such products, and through subsequent communication and discussion, a certain consensus can be reached, thereby accelerating the development of gene therapy industry in China.
QIN Xi, YU Lei, TAO Lei, BI Hua, WANG Guang-yu, SHI Xin-chang, ZHOU Yong
. Critical considerations for quality control testing technology of recombinant adeno-associated virus(rAAV) gene therapy products*[J]. Chinese Journal of Pharmaceutical Analysis, 2023
, 43(11)
: 1813
-1819
.
DOI: 10.16155/j.0254-1793.2023.11.01
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