ICH Q5D Derivation and characterisation of cell substrates used for production of biotechnological/biological products - Scientific guideline

This document provides guidance on standards for the derivation of human and animal cell lines and microbial cells to be used in biotechnological/biological products. It outlines recommendation for the preparation and characterisation of cell banks to be used for production.

Keywords: Cell bank, master cell bank, working cell bank, cell line, biotechnological product, biological product, identity, purity, stability, tumourigenicity


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