- Isoenzyme Electrophoresis to indicate consistency with human dermal fibroblast control (see below)
- Karyology analysis (karyotyping) of cell lines (50 metaphases) to confirm diploid status
- Genetic Profiling (STR) to demonstrate comparability to a reference cell line
- Total Viable Cells/Vial
- Cell Viability (post bank thaw)
- Transmission Electron Microscopy (TEM)
TRANSMISSION ELECTRON MICROSCOPY (TEM)
Transmission electron microscopy (TEM) is commonly used to detect retroviruses in test articles and
to type retrovirus particles (A, B, C or D) in cell lines. At least 100 cells are observed and checked for contaminants. If the test article is seen to be contaminated by observation of the cell line in TEM, the detection of retrovirus is then confirmed by direct assays.
TEM can also be used to characterize cell lines and to detect other contaminants such as Mycoplasma, bacteria, fungi and other viruses.