Manufacture capabilities

Our manufacturing site are built to satisfy our clients’ needs from preclinical kg scale production to scaled-up clinical and commercial manufacturing on ton-scale. Our annual MFA and MAA output can reach up to 500 Tons and more. Also,one Single Quality Management system cover across all manufacturing workshops.Our MAA production facility is built with high safety factor of the high-pressure reactors, the entire reaction process is monitored automatic control system, capable of continuous reaction.

cGMP Capabilities

We've designed our equipment placement in GMP workshop under the guidance from QA and EHS standard while maintain its maximum flexibility and capability.

·  Equipment placement is designed for maximum flexibility

·  2 independent production lines with 18 reactors (500-5000l), capable of reaction temperate from -60℃ to 200℃,pressure range from 1 bar to 16 bar.

·  Centrifuge, pressure and vacuum filter

·  Different levels of the production area with air purification system

·  Double cone vacuum, tray vacuum dryer

·  Multifunctional hall (weighing, storage)

·  Isolators and air monitoring

·  Continuous employee training

HPAI Capabilities

We've designed our equipment placement in cGMP workshop under the guidance from QA and EHS standard while maintain its maximum flexibility and capability. We’ve also deployed primary decontamination system within the suites to ensure the qualification of facilities and processing equipment, and continuously train our employees on best production practices and most updated EHS knowledge.

·  API manufacturing

·  50L reactors, 20L rotary evaporator, 50L vacuum drying oven

·  Analytical development, 100D High performance liquid preparation chromatography

·  Handling compounds with an occupational exposure limit conform to OEL-4 level

·  Isolators and air monitoring