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新藥研發 Drugs
新藥研發
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      公司研發部位于研發氛圍濃厚的張江高科技園區實驗室占地面積3000平方米,擁有120余名研發人員。公司研發中心下設項目管理部、藥物合成部、藥物分析部、藥物制劑部、注冊部、藥物情報信息部6個核心部門。

      藥物合成部擁有40余名合成研發人員,50%以上具有博士、碩士學歷。實驗室配備50余個通風櫥和5mL-100L反應設備,具備無水無氧、高溫高壓、超低溫實驗條件;原料藥中試車間有100-5000L搪瓷/不銹鋼反應釜以及高壓氫化車間,為藥物產業化提供有力保障。公司合成實驗部門儀器設備齊全,技術研發實力雄厚,具有高難度、多手性中心藥物的研發能力,已積累了豐富的工藝開發和放大經驗。


02.jpg      藥物分析部配備LC-MS,GC-MS,HPLC40余臺,自動頂空GC,百萬級天平等精密分析設備,具備分析方法開發、光學異構體檢測分離、方法學驗證、有關物質結構確證、基因毒性雜質檢測分析、質量標準制定、藥物一致性評價能力。

      藥物制劑部配備高效濕法制粒機、流化制粒包衣機、干法制粒機、混合機、旋轉式壓片機、流化制粒包衣機、氣流粉碎機、鋁塑(鋁)包裝機、注射劑小型配液過濾系統、凍干機、滅菌柜等設備;口服固體制劑可達到十公斤級以上的生產規模,具備中試放大生產條件;注射劑、粉針劑、軟膏劑等已與國內知名企業建立中試研發平臺;制劑檢測配備有粒度檢測儀、高效液相色譜儀、自動溶出儀等先進設備。

      公司制劑研發實力雄厚,已積累了豐富的普通固體制劑、注射液、凍干劑、滴眼劑、軟膏劑開發經驗,同時具有藥物掩味口腔速崩劑、藥物緩控釋制劑、藥物粉霧吸入劑、混懸緩釋注射劑的技術和人才儲備,并已成功介入緩釋注射劑及吸入制劑的開發。


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