Home About Us Resources 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

Early Phase 

•  Fit-for-purpose process development

•  PMI & COG oriented, implementing cutting-edge technology

•  Extensive experience in most modern organic reactions

Late Phase

•  Robust, green and cost effective

•  Study unit operations of each step (NORs, PARs) and define CPPs

•  Develop control strategy for RSMs, intermediates and APIs

•  Perform process risk analysis


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.


Capacity

• Six workshops in use (4 API lines)

• With 268 reactors: 200–8,000 L (GL, SS, HC)

• Total reactor volume: 505 m3

• A GMP kilo-lab with clean room

• Additional workshop to add in 2023 (2 API lines), with total vol. 190 m3


Special capabilities available

•Cryogenic and high temperature: -118~150°C 

•An isolator for high potency API research

•Achieve OEB 4 with engineering control measurement

•Spray drying


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, passed NMPA PAI with no critical or major findings; ISO9001 certified at Shandong site

•  Thoughtfully followed 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


Click here to have a virtual tour of PharmaBlock Zhejiang manufacturing site.