Our genetic QC solutions
Modern gene editing techniques have redefined the boundaries of biological research, allowing novel cell and gene therapy approaches to combat life-threatening diseases and provide renewed hope to patients.
However, genome editing can still result in undesired outcomes which can be difficult to characterize, and failure to do so can have significant health and financial consequences.
Our TLA-based genetic QC solutions fill a significant gap in the genetic diagnostics market and have been repeatedly endorsed in public literature.
"TLA analysis has proven to be very useful to quality control genetically engineered cell lines”
1. What are some of the most important QC needs in genetic research?
Cergentis provides robust genetic characterization through proprietary TLA-based genetic QC solutions. Our assays have been used in thousands of projects to reliably determine gene editing outcomes in a variety of organisms and cell lines by leading pharma, biotech and renowned research institutes. We provide comprehensive genetic assessment and targeted sequence analysis of (trans)genes to help our customers select and characterize genetically engineered cell lines, animals and biopharmaceutical products.
- Genome editing
- Validate on-target genetic alterations
- Assess undesired sequence variants or structural rearrangements
- Evaluate potential structural effects (translocations) of targeting multiple loci
- Assess integrity of integrated vector sequence
- Assess the quality and efficiency of editing strategy
- Determine heterogeneity of a genome-edited cell pool
- Cell & gene therapy
- Assess integrity of integrated vector sequence
- Evaluate outcome of random integrations in heterogeneous samples
- Reveal overrepresented clones in heterogeneous samples
- Confirm editing and evaluate specificity of on-target integrations
- Assess pool heterogeneity
- Long-term safety and clonality monitoring of immunotherapy (ATMP) in patients
- Cell line development
- Demonstrate a range of genetic characteristics for producer (MCB or MVB) cell lines
- Clone selection
- Detailed reporting and genetic characterization according to FDA and EMA requirements
- Assess integrity of integrated vector sequence
- Clonality assessment
- Genetic stability assessment
- Genetically engineered models
- Identify potential disruptions of genetic regulatory or coding regions after pronuclear microinjection
- Better phenotype-genotype correlation
- Determine zygosity by genotyping (large) transgenic models
- Assess unexpected co-integration
- Assess integrity of integrated vector sequences
- Evaluate the BAC or vector sequence introduced into a model
2. Why opt for TLA-based genetic QC solutions?
a. Unmatched genetic insights
In one experiment, our TLA-based genetic QC solutions can identify vector insertion sites and potential sequence variants, from individual nucleotide variants to large structural rearrangements, on- or off-target. TLA can robustly identify all genetic variation in and around (trans)genes of interest, something that more conventional approaches such as WGS, PCR, FISH or Southern Blot struggle to do. For more information, we invite you to check our comparison table. Since our landmark Nature Biotechnology (2014) publication, our TLA-based method has been widely applied across several application areas to genetically characterize genetically engineered cell lines and modified organisms. To date, our unrivalled genetic QC solutions have been extensively endorsed in over 50 peer-reviewed publications.
To learn more about the unique advantages of our TLA-based assays for your application area, please click on the relevant icons below.
Our genetic QC solutions
b. Included in regulatory filings and favorably reviewed by FDA
ATMP (advanced therapy medicinal product) development requires thorough genetic characterization for development and commercialization. Your filing will require solid evidence and detailed documentation of the genetic characterization your product(s). Genetic QC is heavily monitored by FDA and EMA officials and may significantly influence their decision.
That’s why our detailed TLA reporting complies with FDA and EMA requirements (ICH guidelines Q5B and Q5D, CTD Quality module, section 3.2.S.2.3) and is suitable for inclusion in regulatory applications for pharmaceuticals for human use.
TLA data has been used for both early and late stage trials, for a range of processes:
- Early stage (phase I, IND/NDA)
- Late stage (phase III, BLA)
- (Master) Cell Bank characterization
- Genetic stability analysis
- Clonality assessment
For more detailed information, please visit our Cell Line Development or Cell & Gene Therapy pages
Our genetic QC solutions
c. A wide range of TLA-based assays for genetic QC testing
- Mapping exact transgene insertion sites
N/A
- Characterisation of (large) structural variations at integration sites in the host genome
- Complete targeted (trans)gene sequencing
- Detections of sequence variants and structural changes within the transgene
- (Transgene) copy number estimation
- Assessing the quality and efficiency of gene editing
- Confirming on-target genetic alterations
- Assess heterogeneity of genome-edited pools of cells
- QC large integrated vectors and their insertion sites (e.g. BAC, YAC)
- Identity assay for extremely homologous vectors
- Vector sequencing
- Genotyping strategy development
- QC of new transfection/transduction gene editing techniques
- Clone selection
- (MCB) Cell bank characterisation & clonality assessment
- Genetic stability analysis
Genetically engineered (animal) models
Cell line development
Gene therapy & upstream (USP) viral producer cell bank
3. Why should I pick Cergentis over other laboratory testing service providers?
a. Competence
Our dedicated team of scientists is committed to accompanying you in your drug developmental journey by delivering comprehensive genetic QC data through our proprietary solutions and quality management system. Click here to meet all the Cergentis members.
Team backgrounds
Want to read what our customers have to say about our technology? Check out our testimonials!
b. Expertise
Our technology
With almost a decade of experience, Cergentis is an expert in genomic analyses and offers exclusive, patented, TLA-based solutions. We use our unique expertise to analyze thousands of samples each year for leading pharma and biotech players across the world. We have accumulated a deep understanding of genetic outcomes derived from projects involving transgenic animal models, producer cell lines and state-of-the-art genome editing tools. Our team can assist you to get the most meaningful insights into your results, raising your project to the next level.
Strategic partnerships
With a proven track record working within the pharmaceutical and biotech industries, the demand for our TLA-based genetic QC solutions has increased. This has given us the opportunity to collaborate with world-leading partners.
Some notable collaborations
Transgene Mapping AnalysisTaconic
Automation ProtocolPerkinElmer
Chromosonal Haplotyping (TLA & SMRT sequencing)Pacific Biosciences
Apollo X cell line development & clone selectionFUJIFILM Diosynth Biotechnologies
Software (TLA analysis)Genedata
Clonality Assurance (whitepaper)Novartis
Customer feedback helps us refine our processes
We closely interact with our customers and collect their feedback after each project. We put the needs of our customers first and work to continuously improve our reporting and solutions. As a science-driven company, we strive for scientific and data integrity to ensure we deliver every project to the highest standards. Furthermore, we aim to make our project workflow as comfortable as possible for our customers and guarantee timely delivery of our results.
Project workflow in 5 quick easy steps
Scientific consultation
Agreement
Shipment
Analysis & Tracking
Reporting
c. Experience
Extensively endorsed in scientific peer-reviewed literature
Our TLA-based solutions have been featured in >50 peer-reviewed scientific publications.
| Application | Publications | Highlights |
|---|---|---|
| Cell Line Development | 11 | Lonza & Pfizer(2021); Janssen R&D et al. (2020); Novartis (2019); Glenmark (2019); Gilead (2018) |
| Cell & Gene Therapy | 8 | GSK (2020), FDA/NIH (2020); Cellectis (2019); MSKCC (Nature, 2017) |
| Transgenic Models | 26 | NIH (2021); MD Anderson Cancer Center et al. (2020); The Jackson Laboratory (2019); Genentech (2016) |
| Genome Editing | 6 | Harvard University et al. (2019); A*Star & The Jackson Laboratory (2018); GSK & Wellcome Trust (2017) |
Method of choice for complex projects
Our expertise lies in the analysis of complex genetic engineering projects in a wide range of organisms and sample types, including but not limited to chinese hamster ovary (CHO) cells, human cell lines (e.g. T cells, HEK293, HeLa) and transgenic animals (e.g. mice, rats, goats and pigs). In fact, our genetic QC solutions are routinely applied to thousands of samples every year in various projects. Our TLA technology is recognized as the gold standard for complete characterization in genetic research by academia and industry alike.
Organisms analysed by TLA
mosquito
fruit fly
spider
zebrafish
mouse
rat
hamster
chicken
rabbit
goat
pig
cattle
human
Your one-stop shop for genetic testing
- Transposon-mediated integrations
- PiggyBac
- Sleeping Beauty transposon
- CRISPR
- Viral integrations
- AAV
- Lentiviral integration events
- Retroviral
- HIV.HBV
- Etc.
- Random integration events
- Single or multiple vectors
- Targeted integrations via homologous recombination
- Targeted knock-outs
- Large vector (BAC constructs)
- Landing pad methods
- using Fip-FRT/Cre-LoxP
- CHO (Chinese hamster ovaries)
- Human cell lines
- HEK293
- hiPS
- ES
- T-cells
- Etc.
- Primary cells
Cergentis in the news
For more news, please visit our News page.
We are a globally recognized and trusted partner for genetic QC testing
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