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聖濟堂(600227.SH):中觀生物三批幹細胞樣品獲中檢院檢測合格報告
格隆匯 01-02 16:31

格隆匯1月2日丨聖濟堂(600227.SH)公佈,2020年1月2日,公司控股子公司中觀生物收到中檢院頒發的臍帶間充質幹細胞《檢驗報告》。中檢院是國家檢驗藥品生物製品質量的法定機構和最高技術仲裁機構,具有實驗室認可(CNAS)和資質認定(CMA)資格的國家級檢定實驗室。這次檢驗合格的是中觀生物送檢的第二批次、第三批次臍帶間充質幹細胞樣品。分別為臍帶間充質幹細胞(hUMSC-038)第5代(P5)和第10代(P10);臍帶間充質幹細胞(hUMSC-042)第5代(P5)和第10代(P10)。

檢驗結論:細胞株鑑別、細胞形態、細胞自我更新情況、細胞表面抗原分析、細胞乾性標誌、細胞特定分化情況以及免疫調控功能均符合臍帶間充質幹細胞特性。無菌檢驗、支原體檢驗、外源病毒檢驗、逆轉錄病毒檢驗均符合陰性。成瘤性檢查無克隆反應、無致瘤作用。

上述臍帶間充質幹細胞是公司於2019年4月17日送中檢院檢驗的第二批和第三批臍帶間充質幹細胞。截止本公告披露之日,中觀生物已完成三批臍帶間充質幹細胞報檢工作,《檢驗報告》結論均合格。中觀生物三批幹細胞樣品獲得中檢院檢測合格報告,標誌着中觀生物已經完成了關鍵性的幹細胞生產工藝的研發及幹細胞質量控制的研發過程,表明中觀生物具備生產製備合格的臨牀用幹細胞的能力,工藝及質量符合國家幹細胞標準,生產的幹細胞產品經中檢院檢測是安全有效的。

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