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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