Manufacturing
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The state-of-the-art parenteral drug product manufacturing facilities are in Wuxi City drug product site in China and will be expanded to our Couvet site in Switzerland and Middletown Delaware site in the US.
We support various dosage forms and filling formats at any scale from preclinical to commercial manufacturing. We have 5 production lines are featuring fully enclosed isolation systems and automated filling lines, and we support high potency injectable drug product.
Drug Types
- Small molecule
- Oligonucleotide
- Peptide
- Synthetic conjugate
Dose Forms
- Solution / emulsion
- Suspension
- Lyophilized powder
- Advanced formulation, e.g., liposome / LNP
Filling Formats
- Vial
- Prefilled syringe
- Cartridge
Various Products
- Intramuscular / subcutaneous
- Intravenous
- Intrathecal
- Inhalation
- Ophthalmic
Manufacturing Platform
Our sterile plants have passed multiple inspections from global regulatory agencies and clients every year.
- Filling speed: up to 200 units/min
- Batch size: 0.5 L – 2,000 L
- Lyophilizers: up to 20 m2
- Fully contained, modular design & robotic operation to ensure high quality products with minimal human errors
- 5 production lines, more lines to be added in Couvet site, Switzerland and Middletown site, Delaware, USA
High Potency Injectable Drug
The high potency sterile injectable manufacturing line is located at the drug product site in Wuxi City, China. Its Occupational Exposure Limit (OEL) is 10 ng/m3. The fully enclosed isolation systems and automated filling machines minimize both microbial contamination and cross-contamination risks. The line has two 20m2 lyophilizers and supports liquid and lyophilized vials of various specifications. This line can efficiently perform the filling of up to 200 units per minute, achieving an annual capacity of over 12 million units.
Lipid Nanoparticle GMP Manufacturing
This modular designed LNP manufacturing plant in Wuxi City integrates multi-channel chip, micro-mixer system, and complex preparation system into a multi-channel micro-mixer core LNP manufacturing platform, offering significant advantages in drug-loading, liposome particle size control, and encapsulation efficiency. In addition, the modular design provides greater processing flexibility, enabling this platform to serve a wide range of manufacturing scales from 10-50 L per batch. Read More.
Packaging & Labeling
At WuXi STA, we have dedicated outer packaging line for injectable dosage. It supports labeling, automatic box opening and packaging, vial & cartridge automatic cartooning, automatic pallet, drug electronic supervision code and 100% online weighing check under low temperature.
We can provide open study and double-blind labeling options with various formats such as single panel, two panels, booklet, transparent and customized label based on clinical protocol interpretation.
Our packaging department adheres to strict quality control measures as per compliance.
Please refer to our Clinical Supply Service webpage for further packaging, labelling, distribution service.
