On the afternoon of June 19, 2019, an expert panel for stem cell clinical research, organized by the Planning and Evaluation Division of the Department of Science, Technology and Education of the National Health Commission, conducted an on-site inspection of Beike Biotech’s stem cell production at the Beike Building. The expert panel was led by Wu Zhaohui, Secretary-General of the China Medicinal Biotech Association, and included Yuan Baozhu, researcher at the National Institutes for Food and Drug Control; Qian Biyun, Director of the Clinical Research Center at Shanghai Jiao Tong University School of Medicine; Hou Zongliu, Professor at Kunming Yan’an Hospital; Wang Chunshui, Professor at Beijing Obstetrics and Gynecology Hospital; Lyu Xinghua and Wang Liang, officers of the Planning and Evaluation Division of the Department of Science, Technology and Education of the National Health Commission; and Zhang Wen, Director of the Stem Cell Office of the China Medicinal Biotech Association. Director Yuan Baozhu chaired the on-site inspection as the panel head. Xie Changfeng, head of Beike Biotech’s Cell Drug Registration Project Management Department, reported to the panel on the cell sourcing and donor screening, stem cell preparation, stem cell quality control, records, release and other aspects of stem cell production, as well as Beike Biotech’s support for clinical research institutions and clinical research projects. This on-site inspection was conducted to implement the “Notice on Performing the Supervision and Management of Stem Cell Clinical Research in 2019” jointly issued by the National Health Commission and the National Medical Products Administration (NMPA), to effectively promote the standardized management of stem cell clinical research in China, and to carry out comprehensive on-site supervisory inspections of hospitals and institutions across the country with stem cell research projects on file.
The expert panel conducted on-site inquiries and inspections of Beike Biotech’s personnel management, materials management, equipment management, environmental monitoring, management documents, SOPs, analytical methods, quality standards, release procedures, and quality system documents. Dr. Liu Muyun, Liang Xiao, Director of the Cell Preparation Center, and Xu Shaokun, Director of the Quality Management Center, gave detailed answers to every question raised by the experts.
The expert panel then carried out an on-site tour of Beike Biotech’s stem cell production facilities and quality testing laboratories, gaining a detailed understanding of the layout of production facilities, the division of functional zones, personnel management, the flow of materials, clearing-the-floor management, instrument and equipment use, and the configuration of quality testing items.
The expert panel and officials also visited the Saidong cell preparation industrial robot. Everyone showed strong interest in the robotic automated cell preparation system, sincerely admiring how Shenzhen enterprises — at the frontline of reform and opening-up — once again stand at the forefront of innovation.
Zhang Yiyu, Director of the Science, Technology and Education Division of the Guangdong Health Commission; Zhou Liping, Director of the Science, Technology and Education Division of the Shenzhen Health Commission; Chen Junhui, Director at Peking University Shenzhen Hospital; Director Zhang Fan; Section Chief Zhang Hong; Director Yu Zhendong; and Deputy Director of the Institute Ji Ping attended the on-site inspection. Multiple colleagues from our company’s Cell Preparation Center, Quality Management Center, and other departments also participated.
—— Beike Biotech ——
Beike Biotech was founded in Shenzhen in 2005. It is one of China’s earliest National High-Tech Enterprises specializing in the clinical translation and technology services of biotherapy technology, a strategic emerging industry.
To date, Beike Biotech has partnered with five hospitals to apply for and successfully complete the National Health Commission’s stem cell clinical research institution filings, including the First Affiliated Hospital of Guangzhou University of Chinese Medicine, Peking University Shenzhen Hospital, Shenzhen People’s Hospital, the Second Affiliated Hospital of Kunming Medical University, and Hubei Shiyan Taihe Hospital;
and has supported three clinical research projects through the filing process, including the Nanjing Drum Tower Hospital project “A Randomized, Blinded, Parallel-Controlled, Multicenter Study of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Lupus Nephritis”; the Peking University Shenzhen Hospital project “A Randomized, Parallel, Controlled Clinical Study on the Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells via Different Transplantation Routes for Type 2 Diabetes”; and the Anhui Provincial Hospital project “Clinical Application Research of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Moderate-to-Severe Refractory Systemic Lupus Erythematosus.”
At the same time, Beike Biotech has obtained AABB accreditation, ISO 9001, ISO 14001, OHSAS 18001, and the National Health Commission’s interlaboratory quality assessment certifications, among other quality system certifications. Strict preparation processes and a comprehensive quality system are the guarantee of stem cell quality, and they are the fundamental reason Beike Biotech has been able to support multiple hospitals in obtaining successful filings as stem cell clinical research institutions and stem cell clinical research projects.
