20年前(1985.9)孙世荃教授在潘自强院士(时任核工业部安防局局长)的引见下会唔了国际原子能机构(IAEA)生命科学部官员 R.Mukherjee 博士,很快在中国辐射防护研究院 (CIRP)和IAEA间签定了关于开展组织移植物辐射灭菌研究协议。1988年在CIRP举办了第二届亚太地区组织库技术培训班,IAEA资助CIRP冷冻干燥机和深低温冰箱来进行组织制备,随后中国辐射防护研究院组织库(CIRPTB)成立。
September,1985, Beijing, Prof. Sun Shiquan was recommend meeting Dr. R. Mukherjee, the official of the life science department of the International Atomic Energy Agency (IAEA). Soon, the China institute for radiation protection (CIRP)and the International Atomic Energy Agency (IAEA) subscribed the agreement of developing investigation at radiation sterilization for tissue graft. In 1988, CIRP held the secondPacific Asia region tissue bank technique training class. IAEA provided financial assistanceto CIRP for the equipment of lyophilizer and ultra deep freezer to undertake the tissue preparation. Later, China Institute for Radiation Protection Tissue Bank was established.
The original intention of the IAEA Region Cooperation Agreement (RCA) was to establish and generalize the irradiation sterilization technique on tissue processing to provide safety and effective tissue grafts to the clinic. So the CIRPTB concentrates on translate its technique from the laboratory research to the clinical application. With the second Pacific Asia region tissue bank technique training class held successfully (1992), Shanxi Provincial Tissue Bank (SPTB) was established in 1994 and began to supply a batch production of tissue grafts to clinical practice.
SPTB is a non-profit organization. It engaged in the research, education, preparation, quality control of the allograft based on donated mankind tissue. and, it also engage the work on public awareness of tissue donation, expanding the clinical application of tissue grafts. SPTB also provide implantation technique information to the clinical doctor to promote the development of the tissue banking and tissue transplantation in China. We have held three nationwide bone transplants seminars and a bone banking training class up to now.
Along with Chinese government system reform and the development of the clinical technique, the mankind tissue grafts are regulated by the State Food and Drug Administration and classified to the third type of medical device. Its industrialized production and sales must be licensed from SFDA for marketing of bone allografts to the hospitals. In 1999, Shanxi OsteoRad Biomaterial Co., Ltd. was founded. Prof. Li Bao Xing, director of Shanxi Provincial Tissue Bank, was elected as the general manager of OsteoRad Co., Ltd.
Based upon scientific management and rigorous quality control, the yield and quality of the allografts product ascend a new step. The yield of tissue grafts increased by 50% in growth rate annually. Now, our products have already been extended to more than 400 hospitals in the whole country and about 40 thousands of patients have already recover from various bone illness through bone allograft implantation. Allogeneic Bone Grafts got the first approval of productive registration from State Food and DrugAdministration in 2001.
OsteoRad Corporation / SPTB has 35 employees currently, among them there are four professors (two are post-graduate mentor ), four associate researchers, four senior lab assistants, threehigh grade technician and fourteen post-graduates（Ph.D and master`s degree）.
The OsteoRad Corporation has already owned nine national patented products and techniques, awarded one of first grade prize of ministerial science and technology advancement and one second grade prize, and fulfilled two military resear chcontracts and five item from provincial or national sections.
Now OsteoRad cover 1800 square meters production area, including 500 square meters of ten thousand class clean room. We have owned one set of advanced processing equipments and facilities and built a series of laboratories: pathology, chemistry, microorganism, biomechanics, electron microscope, animal dissection, and tissue engineering, etc.
OsteoRad quality management systemhas been granted ISO9001:2008 and ISO13485:2003 certification by CMD