Genetic Stability Testing
Genetic stability testing is used to analyze a production strain's stability. Specifically, it demonstrates that the expression system has not undergone any mutations or rearrangements that would affect the integrity of the product.
- Bacterial and Yeast Cell Banks
- Cell Culture Cell Banks
- Gene Therapy Products
- Genetically Modified Crop/Plant Analysis
- DNA and RNA Preparation
- PCR and RT-PCR
- Confirmatory DNA Sequencing
- Restriction Analysis
- Insertion Number Determination
- Copy Number Determination
- Plasmid Loss Analysis
- Phage Detection
For MCBs, Lark determines the integrity of the gene expression plasmid for the bulk of the cell mass and for a statistically significant number of clones. This method of analysis is dictated by the ability of certain cells to overgrow the bulk of the culture during the amplification process that occurs as the MCB is expanded to WCB and production scale processes. The analysis process 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 number of cells with missing or mutated genetic elements present in the cell bank. For the MCB, WCB and EPC, restriction mapping, Southern blot analysis and sequencing is performed on DNA prepared from the bulk of the cells.
Lark Technologies, Inc., 9441 W. Sam Houston Pkwy. South, Suite 103, Houston, TX 77099. Tel: 713-779-3663; Fax: 713-779-1661.