R&D Capability

从路线开发到注册研究的研发能力R&D Capability From Route Development to Registration Research

围绕 API、医药中间体和定制化学品项目,支持合成研发、质量研究、注册资料和工艺放大。For APIs, pharmaceutical intermediates and custom chemicals, we support synthetic R&D, quality research, regulatory documentation and process scale-up.

R&D laboratory

合成研发Synthetic R&D

支持合成路线建立、实验室小试、定制化学品开发和关键中间体研究。Synthesis setup, lab trials, custom chemical development and key intermediate studies.

Analytical laboratory instruments

质量研究Quality Research

配备 HPLC、GC、UV、KF、IR、GC-MS、LC-MS、ICP-MS、稳定性箱和制备色谱等设备。Equipped with HPLC, GC, UV, KF, IR, GC-MS, LC-MS, ICP-MS, stability chambers and preparative chromatography.

Pilot reactors

工艺放大Process Scale-Up

覆盖克级、公斤级到吨级的 API 和关键中间体放大生产。Gram, kilogram and ton-scale production for APIs and key intermediates.

Process operation

注册支持Regulatory Support

支持 cGMP 文件、DMF 执行、注册资料管理和法规市场项目推进。cGMP documentation, DMF implementation, registration management and regulated-market project support.

Technology Platforms

质量研究、工艺优化与酶催化平台Quality Research, Process Optimization and Enzyme Catalysis Platforms

Quality research center
01

质量研究与注册中心Quality Research & Registration Center

主要从事化学 API 产品开发、注册和审批支持,中心面积约 1890 m2。Focused on chemical API product development, registration and approval support, with an area of about 1,890 m2.

Process optimization center
02

工艺优化中心Process Optimization Center

支持深冷、高温高压、精馏、微通道、加氢、电渗析和电解反应等工艺条件。Supporting cryogenic reaction, high temperature and pressure, distillation, microchannel reaction, hydrogenation, electrodialysis and electrolytic reaction.

Enzyme catalysis center
03

酶催化技术中心Enzyme Catalysis Technology Center

面向酶改造、酶催化应用和酶制剂商业化开发,配备从小试到中试的发酵和后处理设备。Dedicated to enzyme modification, enzyme catalysis application and commercial enzyme preparation development.