Announcement of “Regulations on Manufacturing Quality Management for Chimeric Antigen Receptor T Cell (CAR-T cell)-based Drug Products”

In recent years, immunotherapy has experienced a series of rapid developments. New immunotherapy technologies represented by specific adoptive immune cell therapy and immune checkpoint antibody therapy have become the focus of common concern in academia and industry due to their significant therapeutic effects in clinical research. Among them, chimeric antigen receptor T-cell immunotherapy (CAR-T therapy) has become a hot topic of research at home and abroad because of its significant therapeutic effects in the treatment of diseases such as leukemia, lymphoma, and multiple myeloma. With the continuous deepening of my country's research on CAR-T technology, the active layout of domestic enterprises and the extension of the industrial chain, my country's CAR-T cell therapy technology is also following the development of international trends. Complying with the Good Manufacturing Practice (GMP) is the principle requirement for the preparation of CAR-T cell preparations. Previously, the China Pharmaceutical Biotechnology Association has formulated the Self-Discipline Standard for Quality Management of Immune Cell Preparations to help institutions avoid contamination, cross-contamination, confusion and errors in the preparation of immune cell preparations, and to maximize the safety and biological effects of immune cell preparations. However, as a special type of immune cell, CAR-T cells have particularities in preparation and quality control. In order to meet the needs of my country's CAR-T cell therapy industry, strengthen the quality management of CAR-T cell therapy, standardize the cell preparation process, ensure the quality of CAR-T cell preparations in clinical research and application, and promote exchanges between domestic and foreign peers, the China Pharmaceutical Biotechnology Association has formulated the "Quality Management Specifications for the Preparation of CAR-T Cell Preparations" based on the existing "Self-Discipline Specifications for the Quality Management of Immune Cell Preparations" and according to the particularity of CAR-T cells. Other requirements involved in the preparation of CAR-T cell preparations, such as personnel, equipment, sample storage and transportation, identification and traceability systems, should be implemented in accordance with the "Self-Discipline Specifications for the Quality Management of Immune Cell Preparations" formulated by the China Pharmaceutical Biotechnology Association.

Specific news link: Announcement on the release of the "Quality Management Specifications for the Preparation of Chimeric Antigen Receptor Modified T Cells (CAR-T Cells)"