Genetic Quality Control Testing | Cergentis + Solvias

Unmatched genetic QC solutions for biologics and ATMPs

With our proprietary Targeted Locus Amplification (TLA) platform developed by Cergentis, we can conduct complete and targeted gene sequencing to facilitate the detection of all single nucleotide variants (SNVs) and structural variants. Adopting the right analytical QC tools for genetic testing is essential to safeguard quality, safety, consistency, and efficacy of biologics and cell and gene therapies.

Unique combination of benefits

Use of TLA and next-generation sequencing for accurate vector integration evaluation, including (trans) gene integration sites, transgene sequence variants and large rearrangements
Complementary ddPCR for determining vector copy number in edited cells
Compatibility with viral and non-viral vectors

Comprehensive ICH Q5B compliant analysis
Confirmation of sequence consistency for genetic stability
Rapid, cost-effective clone screening for efficient candidate selection

Comprehensive service solutions

Solvias offers robust genetic QC solutions for comprehensive genetic assessments and targeted sequence analysis. Our technology accurately determines gene editing outcomes, helping select and characterize advanced therapy medicinal products (ATMP), genetically engineered cell lines, integration sites of lentiviral vectors, and animal models.

Streamlining cell line development is essential for risk management and expediting early-phase testing amid a growing pipeline of candidate molecules. Our TLA-based solutions can help you evaluate the consequences of your genetic engineering. Through our information-rich data, our experts will ensure that your tools are sufficiently robust in the actual production.

Optimization and validation of new editing methods
Clone selection
CHOice® (fully integrated in-house solution for CHO cell clone selection)
Full (master) cell bank characterization
Clonality assurance package
Genetic stability package
Customized validated assays
Vector copy number determination by droplet digital PCR

Using proven analytical solutions, our expert team will validate and refine your processes by confirming genome editing results in your clonal and heterogeneous cell samples, and ensuring robust production methods.

Optimization and validation of new editing methods
Process development and validation
MCB characterization for ex vivo gene and cell therapy applications
Genetic stability package
Customized validated assays
Vector copy number determination by droplet digital PCR

Our proprietary Targeted Locus Amplification (TLA) platform developed by Cergentis detects genetic variations in and around the gene of interest. We offer unrivaled genetic insights as a cost-effective and time-efficient alternative to conventional QC approaches.