Manufacturing
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WuXi STA has been manufacturing clinical trial materials (CTM) since 2008, supplying thousands of batches to USA, UK, EU, China, Japan, Korea, Australia, New Zeal and Thailand. Currently we are producing 8 commercial drug products to all major markets.
In 2023 alone, we have delivered over 2,500 clinical and commercial batches.
We have 40+ isolated manufacturing bays allowing for parallel production to accelerate time sensitive supplies. Specifically, we also have the manufacturing facilities for high potency oral drug product at Wuxi city site. All facilities across China, Europe and the US share the same global standard, approved by all major regulatory agencies.
Manufacturing Platform
(high shear & fluidised bed)
(extrusion & spheronisation)
High Potency Oral Drug
We have established high potency oral solid dosage manufacturing facilities in Wuxi City. The Wuxi city site supports high potency oral drugs with formulation development services and drug product manufacturing services with our consistent global high standards.
Our high potency oral drug manufacturing plants feature fully enclosed production system with automated equipment. Its Containment Performance Target (CPT) meets the control requirements of Occupational Exposure Limit (OEL) as low as 10 ng/m3. We offer multiple formulation processes, including wet and dry granulation, capsule filling, tablet compression, and coating. Our commercial production capacity is 600 million doses.
Continuous Manufacturing
WuXi STA has a state-of-the-art drug product continuous manufacturing (CM) line for oral solids in Wuxi City site, China. It features continuous direct compression equipment with unit operations including dispensing, blending, lubrication, tablet compression, and coating. The equipment design complies with the global GMP regulations. Process Analytical Technology (PAT) is implemented within the CM line to monitor blending uniformity, allowing for real-time analysis and control during production to ensure high product quality.
Primary Packaging
At WuXi STA, we understand the need for flexibility at the early stages of clinical testing, the effective dose, stability and compliance. Our packaging teams will work with you to collect the relevant data and test various packaging options as your compound progresses. Packages can be designed to protect from humidity, light and adulteration to ensure high quality. We can manufacture placebo and over-encapsulation for blinding purpose.
Please refer to our Clinical Supply Service webpage for further packaging, labelling, distribution service.
