Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd. (hereinafter referred to as "Jiuzhitang Maker") is a national high-tech enterprise capable of producing clinical-grade stem cells that meet both Chinese and U.S. pharmaceutical regulatory requirements. Always upholding Jiuzhitang’s timeless principle—“A healer should give their all, and a pharmacist should act with integrity”—Jiuzhitang Maker has consistently placed quality at the forefront of its development, leading to a series of remarkable achievements.

Stem cell products are non-terminal sterilization sterile injections. Since no existing sterilization method can currently be applied, it is essential to ensure throughout the entire manufacturing process that the stem cell products remain free from microbial contamination. To achieve this, Jiuzhitang Maker established facilities at the Beijing Daxing Biomedical Base right from its inception. Compliant with China, U.S., and EU cGMP standards A large-scale stem cell R&D and manufacturing base, with the core cell preparation area featuring 4 independent B+A cleanrooms , while also using PMS System Real-time monitoring of particles, airborne microorganisms, and settling bacteria during the preparation process; using TESTO Temperature Online Monitoring System Monitor the operating temperatures of freezers, refrigerators, and incubators in the QC, Preparation, and Storage & Transportation departments; use BMS System For the control and monitoring of the air conditioning automatic control system, signal acquisition and control of field devices are performed via PLC, achieving Stable air supply pressure, maintaining ambient temperature and humidity , and monitor and alarm for differential pressure and temperature/humidity levels in specific areas; use SISQP/Plus Document Management System (DMS) Utilizing information-based management tools to control the GMP document management process, among other measures, Ensure that the implementation of the document management program complies with regulatory requirements. Jiuzhitang Maker's first-class preparation environment lays a solid foundation for superior stem cell product quality.

Jiuzhitang Maker's comprehensive and well-rounded management system development is a critical factor in ensuring the quality of its stem cell products. In February 2023, Jiuzhitang Maker successfully obtained international certifications for three key systems—ISO 9001, ISO 14001, and ISO 45001—marking the company's robust implementation of its quality management, environmental management, and occupational health and safety management systems. Fully aligned with international standards. 。

Jiuzhitang Maker places great emphasis on quality, consistently strengthening its quality management system and enhancing its quality-control capabilities. Currently, Jiuzhitang Maker has already According to pharmaceutical GMP standards , established seven major modules covering quality assurance, laboratory control, preparation and packaging, facilities and equipment, human resources, material management, and pharmacovigilance, A comprehensive quality management system comprising more than 900 documents and records 。

On February 7, 2023, Jiuzhitang Maker successfully completed the on-site inspection for the "Self-Regulatory Standards for Quality Management in Stem Cell Preparation" certification by the China Association for Medical Biotechnology, earning the "Certificate of Compliance for Quality Management in Stem Cell Preparation" and officially becoming A stem cell preparation company certified by the China Association of Medical Biotechnology 。

"The Self-Regulatory Guidelines for Quality Management in Stem Cell Preparation" is Developed by the China Association of Medical Biotechnology in accordance with relevant domestic and international regulations and guidelines. , China's important management guidelines specifically tailored for the stem cell preparation industry aim to strengthen industry self-regulation in ensuring high-quality stem cell preparation practices. Ensure the consistent and reliable preparation of stem cell products that meet quality standards and are suitable for their intended use. , ensuring the healthy development of the stem cell industry and safeguarding patient medication safety.

Jiuzhitang Maker maintains strict process control throughout the preparation procedure, has established comprehensive quality standards for cell banks at all levels, and places great emphasis on quality research while continuously refining its testing framework. Currently, The mesenchymal stem cell product developed by Jiuzhitang Maker has passed the quality re-examination conducted by the China National Institute for Food and Drug Control, earning a qualified inspection report. 。