Genetic Stability    

Stability testing of genetically engineered prokaryotic or eukaryotic cells is an essential component for quality assurance of production cell banks. ACGT, Inc. offers genetic stability testing to characterize Master Cell Banks (MCB), Working Cell Banks (WCB), and End of Production Cells (EOP) from bacterial, yeast, and cell cultures.

The analysis process starts with the isolation of a sufficient number of clones to adequately sample the population of cells in the culture. Restriction mapping, Southern blot analysis and sequencing are performed on DNA prepared from the clones. ACGT, Inc. provides sequence verification by direct analysis of RT-PCR fragments targeting the appropriate mRNA for the MCB as well as the WCB and EPC. Southern blot analysis is performed to confirm the stability of chromosome inserted expression cassettes.

 Service Description:

- Both absolute quantitation (AQ) and relative quantitation (RQ) RT-qPCR
- DNA/RNA extraction from MCBs, and WCBs, and EOPs
- Transgene insertion copy number analyzed by qPCR
- Phage detection and residual DNA analyzedsis by qPCR
- Structural analysis (insertion sites/restriction analysis) by Southern blot
- Transcriptome analysis by RT-PCR and DNA sequencing
- RT-qPCR for expression analysis
- 21 CFR 58 compliant (GLP), optional

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