Cells used for the production of biotherapeutic products must be evaluated in accordance with the regulatory standards outlined in ICH Q5D. Texcell offers several assays to meet your cell bank characterization needs.
DNA fingerprinting by STR assay
Identity testing by cox-1 gene sequencing
Next-generation sequencing (NGS)Other tests (like gene expression analysis, RNA 16S amplification and sequencing or karyology G-band and M-FISH) are available, dependent on the origin of the cells and the destination of the cells.