Recently, three group standards led by the Dalian Institute of Chemical Physics, Chinese Academy of Sciences, including "General Terms for Organ Chips" (T/CSB 0003-2024), "Intestine Organ Chip" (T/CSB 0004-2024), and "Liver Organ Chip" (T/CSB 0005-2024), have been officially released with approval from the Chinese Society of Biotechnology. These standards lay the foundation for the interoperability and widespread application of organ chip models.
Organ chips, a rapidly advancing frontier biotechnology in recent years, can simulate key structures and functional characteristics of human organ tissues in vitro. They can predict various responses of human organs to stimuli like drugs, construct novel models for human physiology and pathology research, and have broad prospects in biological research, disease modeling, toxicity prediction, and new drug development.
In recent years, organ chip technology has been continuously evolving, expanding its application space, and driving innovation in life sciences and medicine research. However, as a novel non-clinical trial method, organ chips lack consistent standards in common and essential elements such as classification definitions, structural design, cell sources, preparation processes, model construction, and functional validation. This has become a major bottleneck for the industrialization and widespread application of organ chips.
Led by Researcher Jianhua Qin from the Dalian Institute of Chemical Physics, Chinese Academy of Sciences, a working group for drafting organ chip standards was established in collaboration with experts from the China National Institute of Standardization, China National Institutes for Food and Drug Control, China Pharmaceutical University, Academy of Military Medical Sciences, and Tsinghua University. Referring to national standards, laws/regulations, and provisions, the group focused on scientific validity, applicability, and operability. After multiple rounds of consultations, discussions, and revisions, the three group standards for organ chips were formulated and proposed by the Chinese Society of Biotechnology.
The release of these three group standards clarifies the general terms and definitions for organ chips, standardizes the operational procedures, requirements, and methods for establishing and functionally testing intestine and liver chips. This development is expected to provide an important basis for the coordinated development of organ chips in technology, industry, standardization, and scientific supervision.
