Bank Characterization with Texcell
Cell bank characterization is required for banks utilized in the production of biotherapeutic products. Banks must be evaluated in accordance with the regulatory standards outlined in ICH Q5D “Quality of Biological Products: Derivatives and Characterization of Cell Substrates Used for Production of Biotechnological/ Biological Products.” In compliance with this document, Texcell offers several assays to meet your cell bank characterization needs.
Available assays include:
- Karyology G-band and M-FISH
- RNA 16S amplification and sequencing for strain identification
- DNA fingerprinting by STR assay
- Identity testing by cox-1 gene sequencing
- Next-generation sequencing (NGS)
Don’t see an assay you are looking for? Texcell is always adding new capabilities, and designing custom assays to meet our client’s needs. Reach out to our team today to learn more. www.texcell.com | firstname.lastname@example.org
Don’t know what to test?
To determine what characterization assays may be required, Texcell always recommends reaching out to the regulatory authorities, or your quality assurance team. The tests to be carried out are dependent on the origin of the cells in question. For example, to evaluate the origin of the cell lines, isoenzyme analysis is generally requested, but if the cell line is derived from a heterohybridoma e.g. human/mouse, DNA fingerprinting may be required.
Generally, the master cell bank (MCB), working cell bank (WCB), and end-of-production cell bank (EPCB) undergo characterization evaluation.
Where to begin?
Reach out to Texcell today to receive our catalog of available tests as well as a cell banking questionnaire.