Services

TLA-based Services for Genetic Engineering

With a dedicated team of PhD-level scientists and nearly a decade of experience in the field, Cergentis is your trusted partner for the complete genetic characterization of genetically engineered cell lines, animals and cell therapy products.

We provide both routine and tailored services based on our proprietary TLA technology for targeted complete Next Generation Sequencing of genes and transgenes of interest across 100kb, in a single TLA experiment.

Our analyses are always carefully designed in close consultation with our customers.

Pricing for standard TLA service projects start at €2,650 per sample* and include the following:

  • TLA prep and amplification
  • NGS prep and sequencing
  • Data analysis
  • Reporting

 

See example reports for: CHO cells,         transgenic mouse line (homologous recombination),       trangenic mouse line (random integration)        transgenic human cell line (random integration)

The standard turnaround time is 6 weeks from receipt of the samples and relevant sequence information. We also offer expedited services with a turnaround time of 4 weeks, in case you desire even quicker access to your results.

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Cergentis offers a personal dashboard for real-time project statuses, relevant documents and secured submission and storage of sample data and results.

Our expertise lies in the analysis of (complex) genetic engineering projects in various organisms and sample types, including CHO, human cell lines (T cells, HEK293, HeLa, etc.) and transgenic animals (mice, rats, goats, pigs, etc.).

In addition to TLA, Cergentis offers a range of services to further characterise your transgenic and genome-edited model, including:

  • Plasmid or vector sequencing
  • Genotyping primer design
  • Clonality Assurance Package (see below)
  • Genetic Stability Package (see below)
  • Premium Package (see below)

 

For more information on our services and how we may support your project, please contact our sales team.

TLA TECHNOLOGY MANUAL 

* contact us for reduced academic prices

Additional Service Packages
  • CLONALITY ASSURANCE PACKAGE

    TLA combined with breakpoint-based qPCR for rapid, cost-effective clonality assurance of your master cell bank (MCB).

     

    MOST POPULAR


    Starting at €25,000 Includes analysis of:
    •    MCB + control sample
           •    4 primer sets with extended sequencing
    •    93 subclones + 3 controls (96 samples total*)
           •    2 breakpoint qPCR analyses per sample


    Deliverables:

    Extensive report meeting regulatory requirements, describing:
    •    Vector integrity (MCB sample)
    •    Integration site analysis (MCB)
    •    Results of evaluation of MCB specific breakpoints in 93 subclones
    •    Statistical calculation of probability of clonality of MCB

    -> 12 week turnaround time


    *subclone generation not included
     

  • GENETIC STABILITY PACKAGE

    Complete genetic analysis and documentation of the genetic make-up and genetic stability across various generations 
    (e.g. MCB, WCB 3 generation times, EOP) characterizing your cell line at 5 different time points using TLA to gain genetic insight into consistent production of your biologics.


    Starting at €25,000 Includes analysis of:
    •    up to 5 samples (e.g. MCB, WCB, EOP, PPC) compliant with ICH Topic Q5D
           •    4 primer sets with extended sequencing


    Deliverables:
    Extensive report meeting regulatory requirements, describing:
    •    Vector integrity (all samples)
    •    Integration site analysis (all samples)
    •    Comparison of all samples


    -> 8 week turnaround time
     

  • PREMIUM PACKAGE

    Clonality assurance and genetic stability analysis: the full package.


    Starting at €45,000 Includes:
    •    Clonality Assurance Package
    •    Genetic Stability Package
     

    -> 12 week turnaround time

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