ST Cell Line Transgene Integrations QC (FISH)

The ST cell line can be used for the industrial production of various biological products, such as vaccines and therapeutic proteins, due to its ability to rapidly grow and produce high yields.

According to ICH Q5B and Q5D guidelines, regulating agencies request that cell substrates must be analyzed at two time points (i.e., on the level of the Master Cell Bank and on the level of the End of Production cells) to show their genetic stability. Typical assays include those intended to confirm the integrity of the transgene transcript, the genome structure at integration site, and the ratio of insert gene copy number. With many years of experience and in-depth knowledge, Creative Bioarray can use FISH method to confirm the integration of transgenes and determine their chromosome band location. We guarantee the speed, quality and cost of our service.

The advantages of using the FISH method to detect the insertion position of transgenes in the ST cell line are:

  • Accuracy: FISH provides the precise location of the inserted transgene, which can be critical in evaluating the functionality of the transgene and any possible off-target effects.
  • Versatility: FISH can be used on a variety of cell types, including ST cells, making it a versatile tool for many different research settings.
  • Visualization: FISH allows for direct visualization of the hybridization signals, providing a clear identification of the transgene location.
  • Speed: Unlike some other methods, FISH can deliver rapid results, Speeding up the overall research or quality control process.
  • No need for cell culture: FISH does not require cell division to detect the gene of interest, which can save time and resources.
  • High Sensitivity: FISH can detect single-copy genes or even repetitive sequences, leading to a high level of sensitivity.

FISH detection of transgene using plasmid probes on rat cell metaphase chromosome.Figure 1. FISH detection of transgene using plasmid probes on rat cell metaphase chromosome.

Features of Creative Bioarray's ST Cell Line Transgene Integrations QC (FISH) Service

  • cDNA (2kb~) or genomic DNA fragment on banded chromosomes
  • Confirm the integration of transgenes
  • Visualize chromosome band location
  • In accordance with ICH Q5B and Q5D guidelines
  • Reporting meeting regulatory requirements
  • Fast turnaround time


  • Full scope support service-from sample preparation through to the final report
  • Detailed report of insertion and transgene position
  • Expert interpretation specific to a new transgenic line

Quotation and ordering

Our customer service representatives are available 24hr a day! We thank you for considering Creative Bioarray as your ST Cell Line Transgene Integrations QC (FISH) Service partner.

All products and services on this website are only suitable for non-medical purposes.

Cell Line Characterization


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