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Shandong Yikeyuan Stem Cell Bioengineering Co., Ltd.

Shandong Yikeyuan Stem Cell Bioengineering Co., Ltd. was incorporated on December 25, 2013. The registered address is located in Room 1509, Block B, Building A2-1, No. 1, North Section of Gangxing 3rd Road, Gaoxin District Comprehensive Free Trade Zone, Jinan City, with its main business scope. For biological genetic engineering technology research and development, technical services, technical consulting, technology transfer; cell product research and development, sales; cargo and technology import and export business.
        Shandong Medical Yuan Multi-energy Stem Cell Bioengineering Co., Ltd. cooperates with the Shandong Provincial Institute of Pharmaceutical Research and is mainly responsible for the promotion of the isolation, extraction, preparation, and preservation of placenta derived stem cells from pluripotent stem cell banks in Shandong Province. The Shandong Provincial Institute of Pharmaceutical Research is a public institution funded and organized by the Shandong Academy of Medical Sciences. It is responsible for the construction and operation of the Shandong Province's pluripotent stem cell bank. Shandong Province's pluripotent stem cell bank was jointly constructed by the Shandong Academy of Medical Sciences and the National Stem Cell Engineering Technology Research Center. The only one in Shandong Province that has been approved by the former Shandong Provincial Department of Health to carry out stem cell storage for stem cells other than cord blood stem cells.
The Shandong Province pluripotent stem cell bank is located in the GMP laboratory building of the Shandong Provincial Institute of Pharmaceutical Research (Shandong Provincial Institute of Medicine) in Zhangqiu City. It is a site for stem cell extraction, separation, storage, and research. The project has invested more than 50 million yuan and the building area is more than 2,500 square meters. In accordance with national standards for the construction of biological laboratories, the company will establish and implement the “GMP for pharmaceutical production” (GMP) and the “Standard for Clean Construction and Acceptance” of the national standard. The construction will be carried out by companies with construction qualifications and construction experience. The construction materials meet the above requirements. .
        1. Laboratory construction. The stem cell extraction plant, microbiological testing laboratory, and stem cell bank were all designed and constructed in accordance with GMP standards. They were divided into four independent areas: quality control area, security area, production operation area, and storage area, which achieved stem cell detection, production, and storage partition management. The quality control area is responsible for the placenta receiving, placenta pathogen detection, production process and final product testing; the safeguarding area is responsible for instrument cleaning and drying sterilization; the production operating area mainly includes two functional areas: separation area and culture area; the storage area is responsible for stem cell products. Storage, sound and improved the donor stem cell library technical standards and stem cell drug quality standards, the formation of a drug-level standardization of stem cell separation, detection, cultivation, amplification and preservation of supporting technology and quality control system, from the source to achieve unified management. The laboratory is equipped with dual power supplies to avoid the impact of power outage on production and storage.
        Scientifically monitor laboratory environments, conduct monthly inspections on the production environment in accordance with 10,000-level cleanliness standards, and make inspection records. In April 2015, after being inspected by the Jinan Medical Device Quality Supervision, Inspection and Management Center of the State Food and Drug Administration, the comprehensive performance indicators of the microbiological laboratory for stem cell extraction workshops met the requirements of the “Cleanroom” in the “Quality Control for Pharmaceutical Production (2010 Revision)” ( Area) Cleanliness (Class C static, Class D) Design level control requirements.
        2. Technical team building.
        Chief Scientist Professor Han Zhongchao is responsible for the design of the pluripotent stem cell bank in Shandong Province and provides technical support for the stem cell bank. Professor Han Zhongchao is one of the founders of stem cell technology in China. He is a professor at the Peking Union Medical College of the Chinese Academy of Medical Sciences, a doctoral tutor, an academician of the French Academy of National Academy of Medical Sciences and the French Academy of Sciences, a director of the National Stem Cell Engineering Technology Research Center, and a national product for cell products. The director of the research center is also the first chairman of the stem cell engineering technology branch of the Chinese Society for Biomedical Engineering, and the Chinese Medical Association organizes the Standing Committee of the Injury Repair and Regeneration Branch. Nankai University, Jinan University, Southeast University, Chongqing Medical University, Fujian Medical University, Ningxia Medical University, and more than 10 part-time or visiting professors. Han Zhongchao and his team are mainly engaged in the research and development of blood vessel cell molecular biology and biotechnology. They have achieved many internationally leading academic achievements in the research of stem cells, megakaryocytes and platelets, angiogenesis and their control, and chemokines. , The earliest publication of the world's leading umbilical cord mesenchymal stem cell separation technology, the invention of the placenta umbilical cord mesenchymal stem cell library construction method, and in 2010 the world's first to invent the placenta tissue sub-pluripotent stem cell library technology platform, in 2011 the world's first to invent the placenta organization Hematopoietic stem cell library technology platform; 3 technical standard certificates of umbilical cord mesenchymal stem cell public library, autologous library and stem cell product, 3 invention patents, this technology has been promoted at home and abroad, promoted the industrialization of stem cell technology and The clinical transformation was awarded the 2013 China Cooperative Innovation Award by the Ministry of Science and Technology and the National Awards Office.
       Shandong Medical Yuanyuan Multi-energy Stem Cell Bioengineering Co., Ltd. (Shandong Province Multi-energy Stem Cell Bank) has more than 60 existing R&D personnel and more than 220 technical extension staff. The main management personnel all have middle and senior technical titles. The person in charge of each department has relevant professional background and years of research or management experience. The technical personnel responsible for cell preparation and storage have a bachelor degree or above in related majors, after professional technical training and GMP training. Quality control assurance and quality inspection personnel have a bachelor degree or above in medicine, pharmacy or related disciplines, more than 3 years of professional work experience, and have rich professional and technical experience and high business guidance capabilities. The person in charge of the archives has a relevant technical secondary school education, basic computer knowledge and certain medical knowledge. All employees are required to go through process and technology training, SOP training, equipment use and maintenance training, pressure vessel operation training, laboratory testing equipment and instrument operation training, and process hygiene and microbiology training.
        3. Equipment and equipment. At present, the laboratory has an inverted microscope, high-speed centrifuge, conductivity meter, dust particle calculator, constant temperature magnetic stirrer, pulsating vacuum sterilizer, XG1.DMXD-0.36B water treatment equipment, 0.25T/H reverse osmosis equipment, the United States Taylor-Wharton gas phase liquid nitrogen tanks, French Meirie biometric detector 3D480, ThermofisherCO2 incubator, ultra-low temperature refrigerator, clean bench and other international advanced equipment and equipment totaled more than 170 sets (sets).

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