On September 23, 2023, the 4th China Stem Cell and Regenerative Medicine Collaborative Innovation Platform Conference and the First Jinfeng Stem Cell Forum were held in Chongqing, which officially released China's first national standard for human stem cells, the Technical Specification for the Management of Pluripotent Stem Cells in Biological Sample Banks (GB/T42466-2023).
The Technical Specification for the Management of Pluripotent Stem Cells in Bio-Sample Banks stipulates the general requirements for the management technology of human pluripotent stem cells and mouse pluripotent stem cells in bio-sample banks, including the general provisions, the management and technical requirements for the collection and reception of raw materials and related data, lineage establishment, resuscitation and cultivation, freezing and storage, quality control, distribution and transportation. The standard applies to the management of human pluripotent stem cells and mouse pluripotent stem cells in biological sample banks, and does not apply to the management of biological samples intended for clinical treatment.
The release of this national standard marks a standard technical support for the management of stem cell sample bank in China, which is of great significance for promoting the standardization and standardized development of stem cell research and application in China, and also provides a pioneer demonstration for the formulation of subsequent relevant standards in the field of stem cells.
Prof. Weidong Tian, head of Chengdu Shilian Health Biological Technology Co., LTD (hereinafter referred to as “Shilian ”), attended the 4th China Stem Cell and Regenerative Medicine Collaborative Innovation Platform Conference and the First Jinfeng Stem Cell Forum and delivered a keynote speech on the topic of “Basic and Clinical Translational Research on Periodontal Disease Treatment with Dental Vesicle Stem Cells” at the conference. He also delivered a keynote speech on “Basic and Clinical Translational Research of Dental Vesicle Stem Cell Therapy for Periodontal Disease”.
Shilian attaches great importance to the standardization research of stem cell industry and actively participates in the standardization work of stem cell industrialization. Shilian has participated in the compilation of two national standards and two local standards of Sichuan Province. In terms of national standards, the two national standards “General Rules for Performance Testing of Automated Pipetting Workstations” (GB/T 41812-2022) and “Performance Evaluation Requirements for Nucleic Acid Target Sequence Quantification Methods in Biotechnology qPCR and dPCR Methods” (GB/T 42077-2022), which are compiled by Shilian, were officially published by the General Administration of Market Supervision and Administration and the Standardization Administration of China in October 2022, and the National Standardization Administration of China in December 2022, respectively. Supervision and Administration Bureau and the State Standardization Administration officially released. In the preparation of local standards, the two local standards of Sichuan Province, namely “Quality Specification for Human Dentally Derived Mesenchymal Stem Cells” and “Specification for the Construction and Management of Human Stem Cell Banks”, in which Shilian participated, have completed the drafting of the drafts of the solicitation of opinions, and are now soliciting opinions from the society widely.
Standards play an important role in leading and regulating the development of the industry. Shilian will give full play to its technical advantages and actively participate in the construction of industry standardization in the field of stem cells, so as to contribute to the high-quality and sustainable development of the stem cell industry.