Genetic Stability Testing

MDS offers genetic stability testing to characterize master cell banks (MCB), master working cell banks (MWCB) and end of production cells (EPC) from bacterial, yeast, insect and mammalian cell cultures.

The analysis starts with the isolation of a sufficient number of clones to adequately sample the population of cells in the culture. The characterization of single clone isolates insures that there are no significant numbers of cells with missing or mutated genetic elements present in the cell bank. Our genetic stability testing services are flexible and available as a complete panel or as individual assays:

• Confirmation of structure map by Southern blot
• Transgene insertion copy number by QPCR
• Phage detection and residual DNA analysis by QPCR
• Structural analysis (insertion sites/restriction analysis) by Southern blot
• Transcription analysis by RT-PCR and DNA sequencing
• Both absolute quantitation (AQ) and relative quantitation (RQ) RT-QPCR
• RT-QPCR for expression analysis
• DNA and tissue banking for ongoing studies
• Confirmatory DNA sequence of plasmids
• Marker retention/plasmid loss by antibiotic resistance

Host Cell DNA Contamination Assay: The determination of the amount of host cell DNA contamination in plasmid, viral, and protein preparations is a crucial piece of information for researchers and manufacturers alike. At MDS we offer two quantitative Real Time PCR assays based on host cell (E. coli or mammalian cell) DNA.

• Fully validated assay
• Rapid turnaround time of 1 to 2 weeks
• High throughput assay performed in 96 well format
• Highly sensitive - assay detects down to 1 pg of DNA
• Wide quantitative range of typically up to 5-7 log
• GLP testing available