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Commercial
The same lines and methods that made the clinical material.
Commercial manufacturing
Five aseptic filling lines with fully enclosed isolation systems and automated filling, at a combined capacity of more than 100 million units a year. Vials, prefilled syringes and cartridges; solutions, lyophilized powders, suspensions, emulsions and liposomal products.
For potent molecules, a dedicated high-potency line at Wuxi City operates at an occupational exposure limit of 10 ng/m³, with two 20 m² lyophilizers, filling up to 200 units a minute for more than 12 million units a year. Conjugates carrying cytotoxic or radionuclide payloads run on that line through commercialization.
Process validation
Across drug product campaigns to date, process performance qualification has a 100 percent success record, including multiple Phase III and commercial programs.
Validation is supported by an analytical operation running more than 85,000 characterization tests a year, using the methods developed alongside the formulation.
Lifecycle management
A commercial drug product accumulates changes: a new market, a container update, an excipient supplier change, a shelf-life extension.
The formulation development, analytical development and manufacturing for a peptide or oligonucleotide product sit in the same organization, on sites in the same network as the API plant, so post-approval changes are assessed against the original development record.
Where it is made
Sterile manufacture for peptides and oligonucleotides runs at Wuxi City, China, with formulation development at Wuxi City and Shanghai Waigaoqiao. The oral platform additionally operates at Couvet, Switzerland, and at San Diego, United States, where the scope is clinical supply.
The same line that made the clinical material
A change of drug product partner at commercialization means re-establishing the packaging configuration, the artwork and the process with an organization that was not there for the clinical work.
Commercial manufacture at WuXi TIDES runs at the sites qualified for it, on the same lines and methods as the clinical supply that preceded it.