ABSTRACT
Careful records of the manipulation of the cell substrate should be maintained throughout its development. During the generation of the cell substrate, one or more specific procedures may be utilized in the ultimate development of the desired characteristics. One of the most important advantages of using serially subcultivated cells to produce biotechnological/biological products is the ability to have a characterized common starting source for each production lot, that is, the preserved bank of cells. 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. The characterization and testing of banked cell substrates are a critical component of the control of biotechnological and biological products.
