Determining the nucleic acid sequence of the transgene used to produce the protein of interest is one of the critical tests carried out to determine the genetic stability of the cell line. During early stages of the development of a recombinant protein drug, the messenger RNA (mRNA) sequence of the transgene is determined for both the Master Cell Bank (MCB) and End of Production Cell (EOP) Bank. This will yield direct evidence that there has been no changes to the genetic code and that the cells have not undergone any significant changes.
In addition to the coding region, the flanking region of the transgene is also an important consideration as this can affect the productivity and expression levels. Sequencing of the flanking region (at the DNA level) is recommended by the ICH guidelines and should be considered prior to phase 3 clinical trials.
BioOutsource uses the ABI 3500 platform for traditional Sanger sequencing. Our team has over 25 years experience in nucleic acid sequencing with a wide array of different organisms and sample types including recombinant proteins from both Human and CHO.
Sequencing Services include:
- High throughput sequencing
- Re-sequencing of genes and or genomic regions
- Single/Multiple read sequencing
- Primer design
- PCR amplification and/or purification
Contact us to discuss your nucleic acid sequencing requirements.