公司發展歷史  

     20年前(1985.9)孫世荃教授在潘自強院士(時任核工業部安防局局長)的引見下會唔了國際原子能機構(IAEA)生命科學部官員 R.Mukherjee 博士,很快在中國輻射防護研究院 (CIRP)和IAEA間簽定了關于開展組織移植物輻射滅菌研究協議。1988年在CIRP舉辦了第二屆亞太地區組織庫技術培訓班,IAEA資助CIRP冷凍干燥機和深低溫冰箱來進行組織制備,隨后中國輻射防護研究院組織庫(CIRPTB)成立。 
   IAEA的RCA(地區和作協議)的初衷是為了建立和普及組織輻照滅菌技術以提供給臨床安全有效的組織移植材料,所以CIRPTB致力于把它的技術從實驗室研究轉向臨床應用。1994年在中國輻射防護研究院組織庫成功舉辦了第二次亞太地區組織庫技術培訓班(1992)的契機上,經過積極努力與山西省衛生廳達成共識,成立了山西省醫用組織庫(SPTB),開始向臨床批量供應組織移植材料,從此進入了一個新的發展階段。 
   山西省醫用組織庫是一個事業單位,它主要從事人類組織的研究、制備、質量控制和發放,同時還兼有公眾遺體捐獻宣傳及拓展組織移植的臨床應用功能。山西省醫用組織庫還向臨床醫生提供相關移植技術信息,以促進中國組織庫和組織移植事業的發展。迄今已成功主辦了三屆全國骨移植研討會和一屆骨庫學習班。 
   隨著我國體制改革的推進和臨床技術發展的需求,人類組織移植材料被納入國家藥品監督管理局管理范疇并定為三類醫療器械,它的工業化生產和發放就要求有相應的市場化機構來運作,1999年山西奧瑞(OsteoRad)生物材料有限公司應運而生,組織庫主任李寶興研究員任公司總經理。
   山西奧瑞生物材料有限公司成立后,依靠科學的管理理念及嚴謹的質量方針,使產品的產量、質量上了一個新的臺階,以每年50%的增長率向國內臨床提供組織移植產品,現已在全國除臺灣省以外所有省份的400余家各級醫院推廣應用,有數萬名患者接受移植得以康復。同種骨移植材料于2001年獲國家藥監局國內首家準產注冊 ,現已兩次獲得重新注冊。
   山西奧瑞生物材料有限公司/山西省醫用組織庫目前有員工35人,其中研究員4名(研究生導師2名),副研究員3名,副主任醫師1名,高級實驗師5名,實驗師4名,高級技師3名,碩士研究生10名,博士3名。從事科研開發人員占50%以上,已具備獨立開發新產品 及承擔國家科研項目能力。公司現已擁有9項國家專利產品及技術,獲省部級科研成果一等獎一項、二、三等獎各兩項。完成預研項目兩項,完成省、部基金項目七項,國家基金兩項;在研預研項目一項,省基金一項。
   山西奧瑞生物材料有限公司現擁有1800平方米的生產區,其中萬級潔凈間500平方米;擁有一整套先進生產設備;擁有 解剖、病理、化學、微生物、生物力學、電鏡及組織工程等實驗室及先進的實驗儀器、設備。 
           

                 公司質量體系通過GB/T19001:2008和YY/T0287:2003體系認證 
                                       

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

 


Powered by CloudDream
电音大蜘蛛彩金