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"P"

pilot scale plant
Guideline or reference source
ICHQ5C stability testing of biotechnological/biological products
Definition
The production of the drug substance or drug product by a procedure fully representative of and simulating that to be applied at manufacturing scale. The methods of cell expansion, harvest, and product purification should be identical except for the scale of production.
Broader Term
manufacturing site
Related Term
pilot scale batch
 

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