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Cergentis

18 Orders Completed
Utrecht, NL

About Cergentis

Cergentis is a genomics-focused biotechnology company that developed the patented Targeted Locus Amplification (TLA) technology, a widely published Next Generation Sequencing (NGS)-based technology. Thanks to its unique resolution and unmatched capabilities, TLA offers unique advantages in the quality control of advanced genetic engineering.


Cergentis has established itself as the go-to partner for the characterization of genetically engineered cell lines, cell and gene therapy products and animal models for the global biopharmaceutical industry and leading research institutes worldwide. We develop and sell kits and services for targeted and complete sequencing of (trans)genes and gene editing events and provide services for the support in R&D in these fields.


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.).

TLA data is widely used in the selection and characterization of genetically engineered cell lines and animals and has been widely used in support of publications. Moreover, Cergentis studies are performed and reported to be acceptable for regulatory filing in accordance with FDA and EMA requirements (CTD module 3.2.S.2.3.).

It is our mission to improve the quality of genetic research: supporting biopharmaceutical R&D will accelerate the development of new treatments with better outcomes for patients all over the world.

Our Services (2)


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Transgene and Integration Site Sequencing

Price on request

Our TLA-based solutions can be applied to determine:

• All sequence changes resulting from targeted genome editing.

• All vector integration sites.

• Structural changes surrounding transgene integration sites.

• Single nucleotide variants in a vector sequence.

• Structural changes in a vector sequence.


Cergentis has established itself as the go-to partner for the characterization of genetically engineered cell lines, and animal models for the global biopharmaceutical industry and leading research institutes worldwide. We develop and sell kits and services for targeted and complete sequencing of (trans)genes and gene editing events and provide services for the support in R&D in these fields.
In a transgene sequencing service project, the following is included: • Sample preparation for TLA • TLA template amplification with PCR • NGS with Illumina NextSeq • Data analysis and reporting • At additional costs we can also support you with plasmid or vector sequencing as well as genotyping primer design.


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TLA-Based Next Generation Sequencing

Targeted Locus Amplification Based Sequencing
Price on request
Cell line development support, clonality assurance package, genetic stability package, Quality control of cell and gene therapy products.

Cell line development support Cergentis routinely supports most leading pharmaceutical companies in their (CHO) cell line development (CLD) process. Our dedicated team of PhD-level scientists has in-depth experience analyzing genetic alterations in various forms. Moreover, we offer detailed reporting suitable for use in the regulatory application for pharmaceuticals for human use, according to FDA and EMA expectations (CTD Quality module, section 3.2.S.2.3.).

We have extensive experience analyzing complex samples with multiple highly homologous vectors as in the case of cell lines for production of bispecific antibodies.

Please find more information here.

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

Please find more information here.

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.

Please find more information here.

Quality control of cell and gene therapy products Cell and gene therapies are important novel approaches to activate immune response, repair pathogenic mutations, and repair or replace damaged tissue or cells. Ensuring correct genetic modification of these products is key in ensuring safe and effective therapies and is important to demonstrate unambiguously during the regulatory approval process.

Please find more information here.

NGS Next Generation Sequencing Illumina gDNA Human Hamster Mouse Rat Rabbit Pig Plants Show 11 more tags Show less

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FileType/PDF Created with Sketch. Cergentis - Novartis Whitepaper - Clonality assurance.pdf

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FileType/PDF Created with Sketch. Cergentis Application Note - Cell & Gene Therapy - Downstream 2020.pdf

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FileType/PDF Created with Sketch. Cergentis Application Note - Genome Editing (2021-01).pdf

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FileType/PDF Created with Sketch. Cergentis Example Report - human_random (CGT upstream) Nov 2020.pdf

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FileType/PDF Created with Sketch. Cergentis Example Report - mouse_random (GEM) Nov 2020.pdf

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FileType/PDF Created with Sketch. Cergentis Example Report - mouse_targeting-with-HA (GEM) Nov 2020.pdf

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FileType/PDF Created with Sketch. Cergentis Example Report_CHO example.pdf

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FileType/PDF Created with Sketch. Cergentis Manual - Terminology Methods used in TLA Analyses.pdf

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  • LC

    Liesbeth CeelenNovember 2020

    It was a real pleasure working with Cergentis ! They understood our needs very well and went the extra mile to communicate everything clearly to us. The project was finished well within the time limits.

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