Home About Us Resource News & Events Sites
Building Blocks

Drug Substance (APIs, Intermediates, RSMs)

Route Scouting

Fast Delivery:  In early development, speed of delivery is the thumb rule. With accumulated chemistry capabilities and availability of diverse building blocks, our motivated and experienced chemists are able to work out innovative routes with high efficiency.


Optimal Route Scouting: To control the risk of changing route in late development, and secure a reliable supply throughout the whole development lifecycle, the team takes safety, efficiency, purity, cost, ease of scale-up, security of raw material supply, and impact on environment into consideration, and aim to design an optimal, fit-to-purpose route for customers' projects. 

Process Development, Optimization and Validation

•  Robust and phase appropriate process development

•  Quality improvement, cost efficient, and PMI reduction driving

•  Working closely with analytical R&D teams to access data on product quality, impurity identities and properties, etc.

•  Process design based on QbD concept

•  Professional chemical engineering teams working with R&D and QA for process validation


Manufacturing

Our extensive manufacturing capabilities, featuring flexibility, reliability and quality, allow us to deliver RSMs, intermediates and APIs for your projects from development to scale-up and commercial production.


Multi-purpose

•  Reactors of different sizes from 50 L to 6,300 L, able to handle a wide range of quantities from grams, to kilos and tons, with a seamless, streamlined technology transfer

•  Multiple operation units to undertake a broad range of chemistries at all scales


Reliability

•  Professional and experienced engineering and production team

•  State-of-the-art design of equipment

•  Facilities are located in national and provincial level chemical industrial parks, with complete infrastructure and policy support

•  Process safety must be assessed for each scale-up project before moving into the workshop


Quality

•  cGMP compliant at Zhejiang, FDA inspected with no Form 483s issued; ISO9001 certified at Shandong site

•  Thoughtfully follewed OHSAS18001 and ISO14001 instructions to build EHS management system and SOPs

•  Passed a number of client audits from top pharmaceutical and biotech companies and third party authorities

Click here to have a close view of manufacturing facilities