ABSTRACT
This chapter provides a broad guidance on appropriate standards for the derivation of human and animal cell lines and microbial cells to be used to prepare biotechnological/biological products, and explores the scope, preparation and characterization of cell banks to be used for production. “Biotechnological/biological products” refers to any products prepared from cells cultivated from cell banks with the exception of microbial metabolites such as, for example, antibiotics, amino acids, carbohydrates, and other low molecular-weight substances. Careful records of the manipulation of the cell substrate should be maintained throughout its development. Description of cell history is only one tool of many used for cell substrate characterization. In general, deficiencies in documented history may not, by itself, be an impediment to product approval, but extensive deficiencies will result in increased reliance on other methods to characterize the cell substrate.
