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Parenteral Manufacturing
Aseptic filling from the first clinical batch to commercial supply, on isolated, automated lines.
The lines
Parenteral drug product manufacturing runs at the Wuxi City drug product site in China, and will extend to Couvet in Switzerland and Middletown, Delaware in the United States. Sterile fill-finish will be added at Middletown in Q4 2027.
Five production lines with fully enclosed isolation systems and automated filling support every dosage form and filling format at any scale from preclinical to commercial, at more than 100 million units of annual capacity.
The sterile plants pass multiple inspections from global regulatory agencies and from clients every year.
Platform specifications
- Filling speed up to 200 units a minute
- Batch size 0.5 L to 2,000 L
- Filling volume as low as 2 mL
- Lyophilizers up to 20 m²
- Line loss below 1% in production, which matters when the API is expensive
- Fully contained, modular design with robotic operation, to minimize microbial and cross-contamination risk
Dose forms and formats
- Dose forms: solution, emulsion and suspension, lyophilized powder, in-situ-forming hydrogels, and advanced formulations including liposomes, lipid nanoparticles, and nanoparticles
- Filling formats: vials, prefilled syringes, cartridges, and LDPE ampoules
- Sterilization: sterile filtration, heat-moist sterilization, irradiation
- Drug types: small molecule, oligonucleotide, peptide, synthetic conjugate, and mRNA or DNA in lipid nanoparticle
Lipid nanoparticle GMP manufacturing
The modular LNP manufacturing plant at Wuxi City integrates a multi-channel chip, a micro-mixer system and a complex preparation system into a multi-channel micro-mixer core platform, which gives advantages in drug loading, particle size control and encapsulation efficiency. The modular design serves manufacturing scales from 10 to 50 L per batch.
Blow-fill-seal
One blow-fill-seal aseptic filling line at Wuxi City, designed for eye drops and inhalants. Volumes from 0.1 to 10 mL, up to 200 units a minute, 9 million units a year.
Packaging and labeling
A dedicated outer packaging line for injectables supports labeling, automatic box opening and packaging, vial and cartridge automatic cartoning, automatic palletising, drug electronic supervision coding, and 100% online weight checking under low temperature.
Open-label and double-blind labeling are available in single panel, two panel, booklet, transparent and customized formats, set against the clinical protocol.
Registration and validation batches
Registration batches are made under the process that will be validated, on the equipment train intended for commercial manufacture, using the analytical methods that go into the filing.