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Vector copy number analysis for engineered cell therapies and CMC

Validated qPCR and dPCR assays for precise vector copy number (VCN) analysis in engineered cell therapies and manufacturing (CMC), aligned with FDA and EMA regulatory expectations.

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Vector copy number analysis

Custom VCN analysis assays for:

Engineered cell therapies

With validated qPCR/dPCR assays, we determine the average number of vector copies per modified cell. The VCN is critical for safety, with current regulatory thinking setting an upper limit of <5 copies per genome to minimize the risk of insertional mutagenesis.

CMC and manufacturing

VCN is a critical quality attribute during process development and lot release of engineered cell products. While not a GMP testing lab, we provide robust, precise, and rapid VCN data to support CMC decision-making and ongoing manufacturing development.

Regulatory-ready data

Our VCN assays are developed and validated under GLP/GCLP, meeting FDA and EMA expectations. Assay precision, accuracy, and sensitivity support IND/IMPD submissions, regulatory audits, and compliance.

Digital PCR advantage

Digital PCR provides absolute quantification without the need for standard curves, offering superior sensitivity, precision, and reproducibility compared to qPCR. The sensitivity makes it particularly valuable for VCN analysis, where detecting small differences in copy number per cell is crucial for ensuring safety, optimizing processes, and gaining regulatory confidence.

A comprehensive guide

Vector copy number assay design and analysis

Vector copy number analysis poses challenges due to low copy numbers, assay sensitivity and specificity requirements, and stringent regulatory demands. Robust qPCR and dPCR methods are essential to generate precise, reproducible results that support safety, efficacy, and compliance in the development and release of advanced cell therapies.

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Vector copy number analysis

Assay design and validation
Regulatory guidelines (EMA and FDA)
Challenges and best practices

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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.

VCN for cell therapies

Vector copy number (VCN) analysis is essential in cell therapy programs to determine the number of vector genomes delivered to or integrated within the host genome. For integrating vectors such as lentivirus or retrovirus, qPCR and dPCR assays are designed against vector-specific sequences (e.g., transgene, promoter, or viral backbone) and normalized to a single-copy host gene to calculate the average copy number per diploid genome. Our workflows combine optimized DNA extraction methods, digital or quantitative PCR, and rigorous assay controls to provide precise and reproducible results that directly support safety evaluations, therapeutic efficacy studies, and regulatory compliance.

Regulatory submissions

Both the FDA and EMA require VCN determination as part of the characterization, safety assessment, and release testing of gene and cell therapy products. Our VCN assays are designed, developed, and validated in alignment with regulatory guidelines, including ICH M10 and S12. Validation covers assay specificity, accuracy, precision, linearity, sensitivity, and robustness across relevant sample types. We operate under GLP/GCLP and ISO/IEC 17025 accreditation, ensuring traceability, data integrity, and audit-readiness.