A well characterized cell bank provides a consistent source of contaminant-free production cells throughout the life of a product. Potential sources for contamination of a cell bank include the origin of the cell line and raw materials to which it has been initially exposed.
We offer microbial cell bank characterization programs which include testing panels designed to detect microbial and viral contaminants and to verify cell line identity for the Master Cell Bank (MCB), Working Cell Bank (WCB), and End-of-Production Cells (EOPC), i.e., cells at the limit (CAL) of in vitro age as designated by the International Conference of Harmonization (ICH).
Assays for Testing MCB, WCB, and EOPC
- Bacterial viruses (bacteriophage)
- Retention of selectable markers
- Retention of recombinant construct
- Copy number determination
- Restriction map analysis
- DNA sequence analysis
- RNA sequence analysis