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High Potency Parenteral Drug Product
A dedicated contained sterile line, under the same quality system as the rest of the network.
A dedicated line
The high potency sterile injectable manufacturing line is at the drug product site in Wuxi City, China, operating at an occupational exposure limit of 10 ng/m³.
Fully enclosed isolation systems and automated filling machines minimize both microbial contamination and cross-contamination risk.
Capability
- Two 20 m² lyophilizers
- Liquid and lyophilized vials in various specifications
- Filling up to 200 units a minute
- Annual capacity of 25 million vials for high potency injectables
Contained across drug substance and drug product
Contained manufacture runs from the API through to the dosage form at the same limit, so a molecule found to be potent mid-program does not have to move to another supplier.
Parenteral
Extensive knowledge to optimize parenteral development and manufacturing.
Manufacturing
Sterile parenteral manufacturing ensuring quality, safety, and flexible scale for injectables.
High Potency API
Supporting small molecule drug substance manufacturing, including high potency drugs.
Analytical
Fast, flexible, and reliable supply for clinical trials at any stage.