We have the capacity and experience to support our clients' cGMP manufacturing needs from early development to commercial scale.

Our FDA approved cGMP manufacturing facility is located in a special economic development zone in Jinshan Shanghai. This facility houses kilo labs, two pilot plants and one commercial plant. The site operates 24/7 and is supported by on-site process engineering, quality, analytical and operation teams.

We are well equipped and experienced to scale-up many types of reactions including asymmetric hydrogenations, air and water sensitive metal catalytic reactions, high temperature, high pressure, low temperature and oxidations reactions.

Our customers can experience an "end-to-end" service from early phase development to commercial launch with industry leading productivity and efficiency through:

  • Co-location of kilo lab, pilot and commercial plants
  • Flexibility enabled 24×7 operations and reactors ranging from 5 L to 20,000 L
  • Experience and expertise in process scale-up and validation

We provide high-quality and cost-competitive commercial manufacturing to our customers, supported by:

  • Dedicated raw material sourcing team ensuring competitive raw material pricing and consistent raw material sources through product lifecycle
  • On site tank farm and solvent recovery capability
  • Seamless transition from development to commercialization maximizing cost savings to customers in the long run

cGMP kilo lab

Our modern cGMP kilo lab can support eight production batches at the same time. It is equipped with 14 glass reactors up to 50 L and can support a temperature range of -78C to 250C.

cGMP pilot plants

We have two pilot plants with a total of 65 multi-purpose reactors ranging from 100 L to 5,000 L. The facility can support reaction temperatures ranging from -80C to 300C and pressures up to 1500 psi. The pilot plant facility is also equipped with two class 100,000 clean rooms for API isolation.

cGMP commercial plant

Our state-of-the-art commercial manufacturing plant has multi-purpose reactors ranging from 3,000 L to 20,000 L and can support a temperatures ranging from -90C to 150C and pressures up to 300 psi. The facility is operated by an automated Distributed Control System (DCS) and adopts a vertical design with no open handling of materials including solvents. The commercial plant is also equipped with two class 100,000 clean rooms for API isolation.

Building on the foundations of STA business, we understand from personal experience what you need and expect from a service provider.

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