intermediate, biological product
- Guideline or reference source
- ICHQ5C stability testing of biotechnological/biological products
- Definition
- For biotechnological/biological products, a material produced during a manufacturing process which is not the drug substance or the drug product but whose manufacture is critical to the successful production of the drug substance or the drug product. Generally, an intermediate will be quantifiable and specifications will be established to determine the successful completion of the manufacturing step prior to continuation of the manufacturing process. This includes material which may undergo further molecular modification or be held for an extended period of time prior to further processing.
- Related Term
- intermediate
- intermediate product
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