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High Potency Oral Drug Product
Contained oral solid manufacture under the same quality system as every other product.
Contained from formulation to supply
High potency oral solid dosage facilities are at the Wuxi City site, which supports high potency oral drugs with both formulation development and drug product manufacturing under the same global standards as the rest of the network.
Contained manufacture continues from the drug substance into the dosage form at the same limit, so a molecule found to be potent mid-program does not have to move to another supplier.
Contained from formulation to supply
High potency oral solid dosage facilities are at the Wuxi City site, which supports high potency oral drugs with both formulation development and drug product manufacturing under the same global standards as the rest of the network.
Contained manufacture continues from the drug substance into the dosage form at the same limit, so a molecule found to be potent mid-program does not have to move to another supplier.
Containment
The high potency oral drug manufacturing plants use a fully enclosed production system with automated equipment. The containment performance target meets an occupational exposure limit as low as 10 ng/m³.
Formulation processes
Wet and dry granulation, capsule filling, tablet compression and coating, all inside containment.
Capacity
Annual capacity for high potency oral solids is 1.1 billion doses.
Every bioavailability enhancement platform is available for high potency compounds at the same limit.
Analytical work that can handle the material
Analytical development, release testing and stability for potent compounds run at the same 10 ng/m³ limit.