ICH topic Q5B - Quality of biotechnological products: analysis of the expression construct in cell lines used for production of r-DNA derived protein products

We have adopted this International Scientific Guideline – ICH Q5B; CPMP/ICH/139/95

Last updated

10 January 2025

About this guideline

Overseas effective date: July 1996

Categories: ICH | Quality

Biologicals | Active substance | Manufacture, characterisation and control of the active substance

TGA Annotations: Nil

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