Human Cell Line Testing
Human cell lines such as HEK293 play a crucial role in the development of cell and gene therapy products. FDA and ICH cell bank requirements are designed to ensure the safety, purity, and consistency of human-derived cells used in therapeutic applications. Compliance is vital for the approval and ongoing monitoring of cell-based therapies, ensuring they are safe and effective for clinical use.
Critical Quality Attributes
Assay
Description
Purity
Mycoplasma Testing
Screen for presence of mycoplasma by QPCR
Adventitious Agent Testing (Human)
Screen for presence of Human adventitious agents by QPCR or NGS
Purity
Mycoplasma Testing
Screen for presence of mycoplasma by QPCR
Sterility Testing
Confirm sterility of cell bank USP <71>
Other
Viability Assay
Ratio of live to dead cells by NC-200 or Flow Cytometry