Long-read DNA sequencing for drug development
Our Oxford Nanopore long-read DNA sequencing enables precise mapping of vector integration sites, detection of structural rearrangements, and assessment of vector integrity, all performed in a regulatory-compliant environment.
Oxford Nanopore DNA applications:
DNA methylation analysis
Nanopore technology directly detects DNA base modifications, such as methylation, providing epigenomic insights to understand gene regulation, chromatin state, and their roles in health and disease.
Vector integrity
Nanopore sequencing detects structural alterations such as deletions, duplication and rearrangements. Long-read sequencing ensures that the therapeutic construct remains intact and is delivered as intended.
Integration site analysis
Oxford Nanopore long-read sequencing enables precise mapping of vector integration sites across the genome. Include also the vector element sequence. E.g., Oxford Nanopore long-read sequencing allows precise mapping of vector integration sites and vector element sequence across the genome.
Regulatory-supportive workflows
Long-read DNA sequencing with Oxford Nanopore is performed in our regulated laboratory, where strict procedures for sample handling, redundancy systems, and data security are in place. Although these assays are not conducted under GLP/GCLP, the controlled environment ensures traceability, robustness, and reliable results across all analyses.
GLP and GCLP compliant laboratory
We are accredited for Good Laboratory Practice (GLP) by the Swedish Board for Accreditation and Conformity Assessment (SWEDAC) for qPCR, dPCR, and molecular biology. In addition, we are Good Clinical Laboratory Practice (GCLP) compliant to ensure the safe and reliable analysis of clinical samples.
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Samples
- Engineered cell therapy products (CAR-T, NK, TCR-T, stem cells)
- Fresh frozen tissues (preclinical & clinical)
- Blood (EDTA or cfDNA stabilization tubes)
Analytes
- Vector integration sites
- Vector structural integrity
- Host genomic structural variants
Oxford Nanopore DNA sequencing is a long-read technology that generates continuous reads spanning thousands to even millions of bases. This enables direct assessment of vector integrity, detection of large structural variants, and precise mapping of integration sites in engineered cell products. Nanopore sequencing can also identify base modifications such as DNA methylation without additional sample preparation.
By contrast, short-read platforms like Illumina provide highly accurate, cost-efficient sequencing of shorter DNA fragments, making them ideal for applications requiring high depth, scalability, and sensitivity for small variants. While short-read sequencing excels at quantification and fine-resolution SNP/indel detection, long-read sequencing provides complementary insights into structural features, methylation, and full-length context.
Resources
Overview of bioanalysis in advanced therapies
- Assay design and validation
- Regulatory guidelines (EMA and FDA)
- Challenges and best practices
Genomic biomarker analysis (DNA, RNA, miRNA, ctDNA etc,)
- Technology overview
- Analytical validation
- Regulatory overview
Capability PDF
Download our latest brochure for a summary of our molecular CRO services and capabilities.