Clonality Assurance & Genetic Stability

Recombinant protein therapeutics, or biologics, are an important class of pharmaceuticals for which Chinese Hamster Ovary (CHO) cells are the most commonly used expression system. Clonality and genetic stability are important for consistent quality over time.


Clonality Assurance

MCB clonal derivation is a regulatory requirement that aims to ensure a robust process and consistent quality over time as described in guidelines by both the FDA (ICH Q5D, 1998) and EMA (EMA, 2016).


Whilst recent developments such as single cell sorting and high-throughput imaging allow for the acquisition of evidence supporting clonality during e.g. an IND or BLA filing, such acceptable assurance may not be available, e.g. for older 'legacy cell lines’.


Rederiving a clonal cell line by additional limited dilutions is time-consuming, costly and, crucially, may affect production and growth rates of cell lines. This is especially undesired when timelines for submission are short.


Cergentis’ TLA technology has established itself as a gold standard in the genetic characterisation of (CHO) producer cell lines as it offers information on transgene integrity and integration sites that surpasses data obtained by conventional methods such as FISH and Southern Blot.


TLA, in combination with breakpoint-based qPCR, can cost-effectively and time-effectively provide assurance of clonality. Cergentis Clonality Assurance Package includes:

  • Full genetic characterisation of MCB and independent control sample by TLA;
  • qPCR-based statistical analysis of 93 subclones;
  • Rapid 10 week turnaround time, including additional reporting 


Cergentis offers follow-up studies to further assess subclone analysis in case of deviating results.

For more information, download our white paper or contact our sales team.




Genetic Stability

In addition to clonality, TLA is routinely deployed to assess genetic stability of (CHO) producer cell lines, which provides genetic insight into consistent production of biologicals.


Within 4 weeks, Cergentis can generate complete documentation on the complete genetic make-up of your master cell bank (MCB), working cell bank (WCB) at 5 different time points and end of production (EOP) cell line to evaluate the genetic stability of your cell line.


See product specifications or contact our sales team.






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