Organoids, often referred to as "living biobanks," are miniature, simplified versions of organs grown in the laboratory. They are derived from stem cells and replicate the structure and function of real organs, making them valuable models for biomedical research and drug testing. Organoids cover two mainstream fields - adult stem cell-derived organoids (also known as patient-derived organoids) and induced pluripotent stem cell-derived and/or embryonic stem cell-derived organoids. These organoids can be cultured in the laboratory, frozen for long-term storage (cryopreservation), and later thawed for continued use, allowing for repeated experimentation and analysis. Their ability to closely mimic human tissue makes them essential for studying diseases and developing new treatments.
Standardization plays a crucial yet often overlooked role in driving technological advancements across diverse fields, including science, technology, economics, and management. In biomedical research, standardization is paramount for generating reproducible, reliable, and meaningful results. As organoids become increasingly important in the development of new drugs, standardized operation and management at every step of organoid construction is vital to ensure high-quality, and consistent outcomes of end products.
Iin this vein, a research team from China led by Dr. Yingyan Yu from Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, and Dr. Hengjun Gao from the National Engineering Center for Biochip at Shanghai, conducted a comprehensive review of the history and current state of standardization in organoid construction, highlighting ongoing challenges. Their review was published in the Chinese Medical Journal on December 12, 2024.
The International Organization for Standardization (ISO), based in Geneva, Switzerland, is responsible for developing and overseeing global standards across various industries, including quality management, environmental management, food safety systems, and many more. Products from different countries compete fairly on a global scale following the international standards set by the ISO. "Standardization is necessary to promote the development of life sciences, improve product quality, and promote the integration and sharing of data," says Dr. Yu.
Organoid creation begins with collecting and preserving human tissue. The tissue should be processed within 30 minutes after collection, by treating it with specific solutions. They are cultured in a controlled environment, with new generations formed every two weeks. Cryopreservation preserves the "living biobank," and organoids can be revived by thawing. Contaminated organoids, indicated by cloudy media or unwanted cells, must be discarded in accordance with the health and safety protocols.
The first international standard in the field of biobank was the ISO 20387, titled 'General Requirements for Biobanking,' published by the ISO in 2018. "Recently, the ISO/TC 276 committee initiated the drafting of organoid-related standards through international collaboration. Our team, as the group, contributed to the drafting process and participated in the first round of feedback," highlights Dr. Yu.
Standardized operating procedures should ideally be followed at every step of organoid preparation. It is important to note that the construction of organoids, which involves the collection and preservation of human biological samples, requires approval from the ethical committee of the sample provider and informed consent from the donor. This consent encompasses, but is not limited to, the preservation of samples, their use in scientific research, drug susceptibility testing, and the potential application of research findings in clinical settings.
In their review, the authors also explored the various standardization systems currently followed in China, including national, field-specific, regional, academic, and enterprise standards. "The construction of high-quality organoids depends on well-established laboratories," says Dr. Yu. "In China, laboratory requirements vary based on the purpose of the experiments conducted. The construction of cell culture rooms is typically divided into three tiers, namely basic research, drug development, and the production of therapeutic biopharmaceuticals," explains Yu.
Despite significant progress, standardizing organoid construction remains challenging due to factors such as variability in cell types and growth rates, particularly in organoids derived from patient tissues. High production costs and technical inconsistencies further hinder the broader application and industrialization of organoid technologies. However, advancements such as AI-assisted evaluation, integration with clinical data, and international initiatives to establish standardized guidelines—like those led by the ISO/TC 276 committee—provide promising prospects.
With continued progress, organoids are poised to become a powerful tool in biomedical research, and standardization will contribute to their widespread implementation.
