Announcement Notification of “Regulations on the Quality Management of Cell Bank Establishment”

In my country, the cell therapy industry is developing rapidly as a strategic emerging industry, and its growth hotspots cover all aspects from cell banks to cell preparation preparation, cell therapy technology research and development, etc. Among them, cell banks, as the upstream of the entire cell therapy industry, are the basis of cell preparation research and development preparation and cell therapy. Only by establishing safe, standardized, stable and traceable cell bank management can the standardization and safety of the entire cell therapy industry be guaranteed from the source.

At present, due to the lack of unified industry standards and management specifications, normal evaluation and communication cannot be carried out between cell banks, or between cell banks and cell preparation institutions or application institutions, which is not conducive to the professional development of the cell therapy industry to a certain extent, resulting in repeated investment and waste of social resources.

In order to meet the needs of my country's cell bank industry, further standardize the quality management of cell banks, and promote exchanges among international peers, it is necessary to formulate quality management specifications for cell banks in China's pharmaceutical biotechnology industry.

Specific news link: Public announcement of "Quality Management Standards for Cell Banks"