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

Current effective version

ICH: Q 5 D: Derivation and characterisation of cell substrates used for production of biotechnological/biological products - Step 5

Adopted Reference Number: CPMP/ICH/294/95 Legal effective date: 31/03/1998

Superseded document

Production and quality control of medicinal products derived by recombinant dna technology

Adopted Reference Number: 3ab1aen Legal effective date: 01/07/1995