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High Potency
Contained fill-finish for potent peptides, oligonucleotides and conjugates, on the same site from first-in-human to launch.
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.
The high potency sterile line
The high-potency sterile injectable manufacturing line is at the drug product site in Wuxi City, China, and operates at an occupational exposure limit of 10 ng/m³.
Fully enclosed isolation systems and automated filling machines work together to minimize the risk of microbial contamination and of cross-contamination. The line is equipped with two 20 m² lyophilizers and supports liquid and lyophilized vials in a range of specifications.
It fills up to 200 units a minute, for an annual capacity above 25 million units.
Conjugates with cytotoxic or radionuclide payloads
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. Potent conjugates run on the same platform as every other sterile product here.
Contained formulation and analytical work
High-potency injectable laboratories operate at the same 10 ng/m³ limit, so pre-formulation, formulation and the analytical work that goes with them do not have to move to a third site.
Analytical development, release testing and stability for potent compounds run at the same containment level.
Contained drug substance
On the drug substance side, process R&D through to commercial manufacture runs across two contained sites, Changzhou and Jinshan, which means a second supply chain exists within the platform.
Laboratory and kilogram scale at both sites, with reactors to 100 litres supporting the full range of reaction chemistry.
Two high potency production plants at Changzhou, with reactors to 3,000 litres, 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.
High potency oral
Contained manufacture also continues into the oral dosage form, at the same 10 ng/m³ limit, with annual capacity running to 1.1 billion doses for high-potency oral solids.
One fewer transfer
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.