The international standard "ISO/TS 23511:2023 Biotechnology - General requirements and considerations for cell line authentication," jointly proposed by BGI-Research and the China National Research Institute of Food Fermentation Industries, was recently released officially. This standard is the world's first international standard that provides specifications for cell line authentication.
The term ‘Cell line’ is refer to a defined population of cells that can be maintained in culture for an extended period of time, retaining stability of certain phenotypes and functions. Cell line authentication is a critical quality control procedure of verifying and identifying cell lines and determining whether they have been contaminated by other cell lines.
As an essential tool in biomedical research, cell lines are fundamental to ensuring the effectiveness of subsequent biomedical experiments. It is estimated that a considerable portion of cell lines stored in the world have been misidentified or cross-contaminated, leading to potential misleading or irreproducible data, causing significant wastage of time and resources. Therefore, standardized cell line authentication procedures are urgently needed to promote the efficient utilization of cell lines.
The international standard released this time is based on the Chinese national standard GB/T 40172-2021 "General guidance on detection methods of mammalian cell cross-contamination”, mainly developed by BGI. It provides relevant terminology definitions in this field, as well as general principles, testing and analysis methods for cell line authentication. The standard specifies the selection of methods, quality control parameters, requirements for data analysis and reporting, and key considerations. It is widely applicable to routine checks of cell culture and preservation in basic research and product fields, as well as cell line source verification in scientific and industrial laboratories, cell banks, and more.
The official release of ISO/TS 23511:2023 marks a significant milestone in the field by addressing a critical gap and providing valuable guidance to stakeholders in the life sciences, biomedical research, and related fields. This standard plays a vital role in mitigating the adverse effects of cell line contamination, such as erroneous research conclusions, irreproducible results, and potential catastrophic consequences in clinical cell therapy.
The proposal for this international standard project was submitted in May 2018 and officially approved through national bodies' voting in July 2019. It attracted the participation of experts from multiple countries. The project drafting group worked within the preliminary framework to develop the content of the standard. They facilitated online discussions with experts from various nations and actively sought insights from relevant international organizations, culminating in the successful official release of this standard.