研發中心

研發部簡介

國藥江蘇威奇達研發中心秉持國藥現代“一體兩翼”的戰略定位和重點發展“5+X”的戰略構想,聚焦“抗感染、抗病毒類、心腦血管類和大健康類”領域,以創新發展和深化改革為內在動力,深入開展高端原料藥的新技術開發。

中心組織架構共分為六大模塊,包含工藝研究、工藝工程、生物工程、質量研究、項目管理和質量管理,功能模塊完整,具備了從項目立項、調研,工藝開發,質量研究,到產品注冊報批的全過程、全系統化研究的科研能力。

 

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工藝研究:建立了具有行業高標準的合成實驗室20個、公斤級實驗室2個,配置了Radleys平行反應儀、Heidolph/Buchi旋轉蒸發儀、在線紅外檢測、電子顯微鏡、程序控溫的恒溫反應浴槽以及過程化研究實驗所需的玻璃反應釜、高低溫一體機、離心機等實驗設備。具備工藝開發及優化、中試放大、工藝工程研究等全流程的工藝研究能力。

質量研究:設立了高標準的分析實驗室2個,配置了Waters/Agilent/Shimadzu高效液相色譜儀、Agilent氣相色譜儀、Binder穩定性試驗箱等先進的儀器設備,配備了專業的質量管理人員,具備方法開發及優化、方法驗證及轉移、注冊報批資料撰寫全過程的質量研究能力;

產業化研究:擁有獨立的多功能車間1個,配置了4套獨立的D級潔凈區,可以同時或分期滿足不同品種原料藥的研究、生產條件。在多能車間建立了擁有十余條專用或多用的生產線,從幾十公斤、幾百公斤到噸級的工藝放大設施(100到5000L搪瓷反應釜、不銹鋼反應釜、高壓釜等各類反應器、配套設備百余臺),具備為集團內兄弟企業及外部客戶提供醫藥定制研發、注冊驗證及生產服務的能力。

 

Sinopharm Jiangsu Weiqida R&D Center adheres to the strategic positioning of Sinopharm Shyndec “one body with two wings” and focuses on the strategic concept of “5+X”, focusing on the fields of “anti-infection, anti-virus, cardiovascular and cerebrovascular and big health”, taking innovation and development and deepening reform as the internal driving force, and deeply carrying out the new technology development of high-end API.

The organization structure of the center is divided into six modules, including process research, process engineering, biological engineering, quality research, project management and quality management. The functional modules are complete, and the center has the scientific research ability of the whole process and systematic research from project approval, investigation and research, process development, quality research to product registration and approval.

Process Research:Establish 20 synthesis laboratories and 2 kilogram laboratories with high industry standards. Equip with Radleys parallel reaction apparatus, Heidolph/Buchi rotary evaporation, online infrared detection, electron microscopy, program-controlled thermostatic reaction bath and process Glass reactors, high and low temperature integrated machines, centrifuges and other experimental equipment required for chemical research experiments. have the ability of process research in the whole process of process development and optimization, pilot scale up and process engineering research, etc.

Quality Research:Establish two high-standard analytical laboratories, equip with advanced equipment such as Waters/Agilent/Shimadzu high performance liquid chromatograph, Agilent gas chromatograph, Binder stability test chamber, and professional quality management personnel. Have the ability of quality research in the whole process of method development and optimization, method verification and transfer, registration and approval document writing.

Industrialization Research:The center has 1 independent multi-functional workshop, equipped with 4 sets of independent D clean areas, which can meet the research and production conditions of different varieties of APIs at the same time or in stages. In the multi-energy workshop, In the multi-energy workshop, more than ten special or multi-purpose production lines have been established, ranging from tens of kilograms, hundreds of kilograms to tons of process amplification facilities (100 to 5000L enamel reactor, stainless steel reactor, autoclave and other reactors, and more than 100 sets of supporting equipment). Have the ability to provide customized pharmaceutical R&D, registration verification and production services for our brothers and external customers.

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