Recently, ISO 23511:2026, Biotechnology—General requirements and considerations for cell line identification and cross-contamination testing, was officially issued, which is the world’s first international standard in the field of cell cross-contamination detection. Led by China, the standard has absorbed the expertise of a multidisciplinary team of professionals from the U.S., the U.K., Japan, Brazil, Canada, Australia, Iran, Nigeria, and other countries.

Cell lines are indispensable core experimental materials for fundamental research in life sciences, the development of the biopharmaceutical industry, and drug discovery. Their authentication and cross-contamination testing are fundamental quality control steps that ensure the reproducibility of research results, the controllability of industrial quality, and the credibility of clinical studies.

Currently, cell line misidentification and cross-contamination exist to varying degrees in cell repositories around the world. This issue has drawn close attention from the international academic community. Many influential SCI journals now require the submission of cell line authentication data, and experts from various countries widely call for the establishment of unified technical standards.

The standard systematically specifies the general principles, detection strategies, and analytical methods for mammalian cell line identification and cross-contamination testing in the field of biotechnology. It also describes the best practices for cell culture, covering aseptic technique, proper use of instruments and reagents, routine cleaning and maintenance, label management, real-time monitoring, as well as regular testing requirements for newly accessioned cells and cells in storage.

The standard safeguards the quality and safety of biopharmaceutical products at the source, and provides key technical support for protecting global human health and well-being and building an internationally coordinated governance system for biotechnology.