Japanese–English glossary
Cell substrate
細胞基材saibō kizai
The cell line, or cells, used to manufacture a biological product, characterized for identity, purity, adventitious agents and genetic stability as described in ICH Q5D. The cell substrate drives viral safety testing and the limits for residual host cell DNA; a tumorigenic cell line, for instance, calls for tighter DNA control. Japanese CMC documents use the term for the production cell line and its banks. The raw materials used to create a cell bank also fall under Japan's Standard for Biological Ingredients, which can be hard to confirm for older banks.