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High Potency and Containment
Contained drug substance, drug product and analytical work for potent compounds, on one platform.
When a molecule turns out to be potent
When a molecule turns out to be potent, the program usually acquires suppliers: the API goes to a containment specialist, the drug product to a second one if the first does not do sterile fill, and the analytical work to whichever laboratory will handle the material. Each is a technology transfer with its own specifications.
At WuXi Chemistry, drug substance and drug product for potent compounds are both made at an occupational exposure limit of 10 ng/m³, on the same platform and under the same quality system as every other molecule.
HPAPI
Process R&D through to commercial manufacture across two contained sites, Changzhou and Jinshan, meaning a second supply chain exists within the platform.
- Laboratory and kilogram scale at both sites, with reactors to 100 liters supporting the full range of reaction chemistry.
- Two high potency production plants at Changzhou, with reactors to 3,000 liters, preparative HPLC and lyophilizers up to 10 m².
Beyond synthesis, the platform covers preparative HPLC purification and particle size reduction by wet and dry milling: jet, pin, conical and hammer. A potent API usually has a particle specification attached to it, and milling under containment is a specialized operation.
Process technology inside containment
Potent compounds can be made in batch or in flow, and the enabling technologies available to any other molecule are available inside containment: flow chemistry, biocatalysis, crystallization and particle engineering, and preparative chromatography.
High potency drug product
Contained manufacture continues into the dosage form, for oral solids and for injectables, at the same 10 ng/m³ limit. Annual capacity runs to 1.1 billion doses for high potency oral solids and 25 million vials for high potency injectables.
For peptides, oligonucleotides and conjugates, a dedicated high potency sterile line at Wuxi City operates at the same containment level, with two 20 m² lyophilizers, filling up to 200 units a minute for 25 million units a year. For conjugates carrying cytotoxic or radionuclide payloads, that line is what allows the program to stay on one site from first-in-human to launch.
Analytical work that can handle the material
Analytical development, release testing and stability for potent compounds run at the same 10 ng/m³ limit.
One fewer transfer
At WuXi Chemistry, drug substance, drug product and analytical work for potent compounds all run at the same containment level, so a molecule found to be potent mid-program does not have to move.