研发中心

国药江苏威奇达研发中心聚焦“抗感染、抗病毒类、心脑血管类和大健康类”领域,以创新发展和深化改革为内在动力,深入开展高端原料药的新技术开发。

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.

中心组织架构共分为六大模块,包含工艺研究、工艺工程、生物工程、质量研究、项目管理和质量管理,功能模块完整,具备了从项目立项、调研,工艺开发,质量研究,到产品注册报批的全过程、全系统化研究的科研能力。

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.

工艺研究:建立了具有行业高标准的合成实验室20个、公斤级实验室2个,配置了Radleys平行反应仪、Heidolph/Buchi旋转蒸发仪、在线红外检测、电子显微镜、程序控温的恒温反应浴槽以及过程化研究实验所需的玻璃反应釜、高低温一体机、离心机等实验设备。具备工艺开发及优化、中试放大、工艺工程研究等全流程的工艺研究能力。

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.

质量研究:设立了高标准的分析实验室2个,配置了Waters/Agilent/Shimadzu高效液相色谱仪、Agilent气相色谱仪、Binder稳定性试验箱等先进的仪器设备,配备了专业的质量管理人员,具备方法开发及优化、方法验证及转移、注册报批资料撰写全过程的质量研究能力;

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.

产业化研究:拥有独立的多功能车间1个,配置了4套独立的D级洁净区,可以同时或分期满足不同品种原料药的研究、生产条件。在多能车间建立了拥有十余条专用或多用的生产线,从几十公斤、几百公斤到吨级的工艺放大设施(100到5000L搪瓷反应釜、不锈钢反应釜、高压釜等各类反应器、配套设备百余台),具备为集团内兄弟企业及外部客户提供医药定制研发、注册验证及生产服务的能力。

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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