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Genetic Stability Testing (GST)

Genetic Stability Testing is the means by which genetically engineered cell lines are analyzed to determine if the integrity of the inserted gene of interest, transcripts and subsequent protein products remain consistent throughout production. It is an essential component of the intracellular analysis required by the FDA CBER to maintain quality assurance of production cell banks (MCB, MWCB, and EPC).  

SeqWright’s FDA quality DNA sequencing and RT-qPCR services are aimed at evaluating the integrity and consistency of resulting transcripts through sequence and qunatitative analyses of RT-PCR products.  

FDA GLP Genetic Stability & Related Services

  1. Confirmatory DNA Sequencing 
  2. RT-QPCR for expression analysis using TaqMan®.
  3. Transgene insertion copy number by QPCR.
  4. Phage detection and residual DNA analysis by QPCR.
  5. Transcriptome analysis by RT-PCR and DNA sequencing.
  6. EBV transformation for maintaining perpetual supplies of DNA.
  7. DNA and tissue banking for ongoing studies.

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