ABSTRACT

The long-term preservation of biological specimens and associated data assists in ensuring reproducibility and comparability in biomedical research. The parameters for cryopreserving a living cell or organism are determined by the desired end use of the preserved material. Identification and characterization of living cells and organisms are key components of a good cryopreservation and storage program. Well-characterized material is a must in a good cryopreservation regimen, as it ensures through each step of the process that control of the effects of handling and preservation is maintained. Maintaining the genetic stability of cells and organisms is a key challenge in the preservation process. The master cell bank is derived from a single tissue or cell line; preparation of the bank requires strict adherence to current good manufacturing practices. All aspects of the development of a cell bank must be well controlled and documented.