On the afternoon of June 19, 2019, a stem cell clinical research expert inspection team organized by the Planning and Evaluation Office of the Department of Science and Education of the National Health Commission went to Beike Building to inspect the Beike Bio stem cell production site. The expert inspection team was led by Wu Zhaohui, Secretary-General of the China Medical and Biotechnology Association, and consisted of experts such as Yuan Baozhu, a researcher at the China Institute of Food and Drug Control, Qian Biyun, director of the Clinical Research Center of Shanghai Jiao Tong University School of Medicine, Hou Zongliu, a professor at Kunming Yan’an Hospital, Wang Chunshui, a professor at Beijing Obstetrics and Gynecology Hospital, Lv Xinghua, a cadre of the Planning and Evaluation Division of the Department of Science and Education of the National Health Commission, Wang Liang, a cadre of the Planning and Evaluation Division of the Department of Science and Education of the National Health Commission, and Zhang Wen, director of the Stem Cell Office of the China Medical and Biotechnology Association. Director Yuan Baozhu presided over the on-site inspection as the leader of the inspection team. Xie Changfeng, head of the new cell drug registration project management department of Beike BiotechReported to the inspection team the status of stem cell production such as cell source and donor screening, stem cell preparation, stem cell quality control, recording and release, as well as Beike Biotech’s support for clinical research institutions and clinical research projects. This on-site inspection is to implement the “Notice on Supervision and Management of Stem Cell Clinical Research in 2019” jointly issued by the National Health Commission and the State Food and Drug Administration, effectively promote the standardized management of stem cell clinical research in my country, and carry out comprehensive on-site supervision and inspection work for hospitals and institutions across the country that have registered stem cell research projects.
The expert group conducted on-site consultation and inspection on Beike Biotech’s production personnel management, material management, equipment management, environmental monitoring, management documents, SOPs, analytical methods, quality standards, release, etc. and quality system documents. Dr. Liu Muyun, Director of the Preparation Center Liang Xiao and Director of the Quality Management Center Xu Shaokun answered the questions raised by the experts in detail.
The expert inspection team then conducted an on-site inspection of Beike Bio’s stem cell production site and quality inspection laboratory, and learned in detail about the production site layout, functional area division, personnel management, material entry and exit, site clearance management, use of instruments and equipment, quality inspection project settings, etc.
The expert inspection team and leaders also visited the Saidong Cell Preparation Industrial Robot. Everyone showed strong interest in the robotic automated cell preparation system. They sincerely admired that at the forefront of reform and opening up, Shenzhen companies once again stood at the forefront of innovation.
Director Zhang Yiyu of the Science and Education Department of the Guangdong Provincial Health Commission, Director Zhou Liping of the Science and Education Department of the Shenzhen Municipal Health Commission, Director Chen Junhui, Director Zhang Fan, Section Chief Zhang Hong, Director Yu Zhendong, and Deputy Director Ji Ping of Peking University Shenzhen Hospital attended the on-site inspection. Many colleagues from our company’s preparation center and quality control center participated in this on-site inspection.
—— Beike Biology——
Beike Biotech was founded in Shenzhen in 2005. It is one of the earliest national high-tech enterprises in my country specializing in the clinical transformation and technical services of biotherapeutic technologies in strategic emerging industries.
Currently, Beike Biotechnology has cooperated with 5 hospitals to apply for and pass the registration of stem cell clinical research institutions by the National Health Commission, including the First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Peking University Shenzhen Hospital, Shenzhen People’s Hospital, the Second Affiliated Hospital of Kunming Medical College, and Hubei Shiyan Taihe Hospital;
It also supports 3 clinical research projects that have passed the filing, including the “Randomized Blind Parallel Control Multicenter Study of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Lupus Nephritis” project of Nanjing Drum Tower Hospital, and the “Different Study of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Lupus Nephritis” project. “A Randomized, Parallel, Controlled Clinical Study on the Safety and Effectiveness of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Type 2 Diabetes Under Transplantation” project and the “Clinical Application Research of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Moderate to Severe Refractory Systemic Lupus Erythematosus” project of Anhui Provincial Hospital.
At the same time, Beike Biotech has passed quality system certifications such as AABB certification, ISO9001, ISO14001, OHSAS18001, and National Health Commission Inter-Agency Quality Assessment Certification. Strict preparation technology and perfect quality system are the quality assurance of stem cells. This is also the fundamental reason why Beike Biotech can support many hospitals to successfully register stem cell clinical research institutions and stem cell clinical research projects.