Genetic stability testing of cell banks is an essential component of the intracellular analysis required to maintain quality assurance of production cell banks (MCB, MWCB, and EPC). QPCR (insertional copy number) and Southern blot (structural analysis) are the mainstay methodologies applied to these studies. An equally vital component of the intracellular evaluation is our FDA level DNA sequencing aimed at evaluating the integrity of the resulting transcript through sequence analysis of RT-PCR products. In order to assure effective transcription of the target gene, we also offer both absolute quantitation (AQ) and relative quantitation (RQ) RT-QPCR.

• gDNA/RNA extraction • Transgene insertion copy number by QPCR   Phage detection and residual DNA analysis 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) • 21 CFR 11 compliant (Electronic Signatures) • Partial implementation of 21 CFR 210/211 (cGMP) such as OOS investigations

Additional Resources • QPCR using Taqman® (info) • EBV transformation for maintaining perpetual supplies of DNA • DNA and tissue banking for ongoing studies • Contact a sales representative about this service (contact info)