Genetic Stability

Stability tests for your cell or virus banks

Genetic stability includes the testing of cell or virus banks at the level of the Master, Working and End of Production Cell or Virus Bank to ensure that the genetic insert is stable. Such testing is a key element of the safety concept for cell-derived biopharmaceutical products and vaccines.

For recombinant cells (mammalian, insect, avian and microbial expression systems) it is of high importance that the gene of interest is stably maintained and expressed during the whole life span of the cell clone. Stable expression is tested and assured by our competent team of molecular experts.

Gene copy numbers determine the number of gene copies of interest per cell, while sequencing then confirms the identity of the gene of interest at the base pair level either DNA or cDNA. In addition to the coding sequence you should check the control elements upstream and downstream.

A Range of Available Genetic Tests

Genetic Tests

Gene Copy Number

To ensure that the gene of interest is stably maintained and expressed during the whole usable life span of the cell clone, specific qPCR assays for gene copy number determination are designed and validated.

DNA Sequencing: Genomic DNA Episomal or Integrated

Genetic stability of an insert within e.g. a cell bank or a virus stock has to be demonstrated. By using Sanger sequencing, the sequence/location of the insert can be compared to the reference sequence and possible mutations/deletions can be detected.

cDNA Sequencing Transcribed RNA

Additionally to the genomic DNA sequencing, the cDNA sequencing is used to confirm the correct transcription of the insert into mRNA.

Sanger sequencing was developed in 1977 by Frederick Sanger, a two-time Nobel Laureate.

Did you know?

Let's Talk About Your Genetic Stability

Tell us about your inquiry and we'll be in touch.