process-related impurities
- Guideline or reference source
- ICHQ6B Test procedures and acceptance criteria for biotechnological/biological products
- Definition
- Impurities that are derived from the manufacturing process. They may be derived from cell substrates (e.g., host cell proteins, host cell DNA), cell culture (e.g., inducers, antibiotics, or media components), or downstream processing (e.g., processing reagents or column leachables).
- Broader Term
- impurity
- Related Term
- product-related impurities
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