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公司发展历史  

     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?#38469;?#22521;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。 
   IAEA的RCA(地区和作协议)的初衷是为了建立和普及组织辐照灭菌?#38469;?#20197;提供给临床安全?#34892;?#30340;组织移植材料,所以CIRPTB致力于把它的?#38469;?#20174;实验室研究转向临床应用。1994年在中国辐射防护研究院组织库成功举办了第二次亚太地区组织库?#38469;?#22521;训班(1992)的契机上,经过积极努力与山西省卫生厅达成共识,成立了山西省医用组织库(SPTB),开始向临床批量供应组织移植材料,从此进入了一个新的发展阶段。 
   山西省医用组织库是一个事业单位,它主要从事人类组织的研究、制备、质量控制和发放,同时还兼有公众遗体捐献宣传及拓展组织移植的临床应用功能。山西省医用组织库还向临床医生提供相关移植?#38469;?#20449;息,以促进中国组织库和组织移植事业的发展。迄今已成功主办了三届全国骨移植研讨会和一届?#24378;?#23398;习班。 
   随着我国体制改革的推进和临床?#38469;?#21457;展的需求,人类组织移植材料被纳入国家药品监督管理局管理?#20923;?#24182;定为三类医疗器械,它的工业化生产和发放就要求有相应的市场化机构来运作,1999年山西奥瑞(OsteoRad)生物材料有限公司应运而生,组织库主任李宝兴研究员任公司总经理。
   山西奥瑞生物材料有限公司成立后,依靠科学的管理理念?#25226;?#35880;的质量方针,使产品的产量、质?#21487;?#20102;一个新的台阶,以每年50%的增长率向国内临床提供组织移植产品,现已在全国除台湾省以外所有省份的400余家各级医院推广应用,有数万名患者接受移植得以康复。同种骨移植材料于2001年获国家药监局国内?#20934;?#20934;产注册 ,现已两次获得重新注册。
   山西奥瑞生物材料有限公司/山西省医用组织库目前有员工35人,其中研究员4名(研?#21487;?#23548;师2名),副研究员3名,副主?#25105;?#24072;1名,高级实验师5名,实验师4名,高级?#38469;?名,硕士研?#21487;?0名,博士3名。从事科研开发人员占50%以上,已具备独立开发新产品 及?#26800;?#22269;家科研项目能力。公司现已拥有9项国家专利产品及?#38469;酰?#33719;省部级科研成果一等奖一项、二、三等?#22791;?#20004;项。完成预研项目两项,完成省、部基金项?#31185;?#39033;,国?#19968;?#37329;两项;在研预研项目一项,省基金一项。
   山西奥瑞生物材料有限公司现拥有1800平方米的生产区,其中万?#30563;?#20928;间500平方米;拥有一整套先进生产设备;拥有 解?#30465;?#30149;理、化学、微生物、生物力学、电?#23548;?#32452;织工程等实验室及先进的实验仪器、设备。 
           

                 公司质量体系通过GB/T19001:2008和YY/T0287:2003体系?#29616;?/font> 
                                       

Company Overview
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

 


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