Key Focus:
CELL + GENE
THERAPY

Empowering the Next Generation of Therapies with Genomics

Cell and gene therapies are redefining what’s possible in modern medicine—turning once-untreatable diseases into curable conditions. From viral vector engineering to CAR-T cell optimization, success in this field depends on precision, safety, and molecular insight. Genomics is the foundation that makes it all possible.

At AUGenomics, we partner with innovators developing advanced therapeutics to ensure every construct, edit, and clone is verified with absolute confidence. Using next-generation sequencing (NGS), we provide end-to-end genomic characterization for cell therapies, gene editing programs, viral vectors, and engineered cell lines—helping your team move from discovery to IND submission with data you can trust.

Confirm vector sequence accuracy and purity

Identify and quantify vector integration sites

Detect off-target genome edits with high sensitivity

Evaluate vector copy number and transgene expression

Characterize clonal diversity and cell population dynamics

Track in vivo vector persistence or immune response

Generate supporting data for IND submissions and regulatory compliance

Why Us?

At AUGenomics, we understand that every therapeutic development program is unique. Our team specializes in custom assay design, rapid turnaround, and data transparency—empowering you to accelerate innovation without compromising precision.

We deliver:

Tailored solutions for vector QC, cell therapy profiling, and gene editing analysis
High sensitivity and accuracy for off-target and integration detection
Scalable workflows suited for both R&D and GMP-adjacent pipelines
Expedited timelines—data in as little as 3–5 days for select projects
Collaborative scientific support from experts in genomics and regulatory data packages
End-to-end transparency via our project portal and dedicated communications team

Our mission is to amplify your innovation—helping you bring safer, more effective therapies to patients faster.

Why Genomics is Central To
Cell + Gene Therapy

Every cell and gene therapy product carries a unique molecular fingerprint. Genomic sequencing reveals this fingerprint in detail, confirming integrity, safety, and performance. Whether you’re developing AAV-based delivery systems, CRISPR-edited models, or engineered immune cells, NGS offers unparalleled visibility into every stage of development.

Genomics supports the cell and gene therapy pipeline by:

Verifying vector identity and purity (detecting off-target or contaminant sequences)
Mapping integration sites and confirming copy number
Validating genome edits and assessing off-target activity
Characterizing transgene expression and vector persistence
Profiling cellular heterogeneity in engineered cell populations
Monitoring clonal expansion and long-term genomic stability

At AUGenomics, our multi-omic and machine learning–enhanced workflows uncover patterns that inform potency, safety, and efficacy. From design to release testing, we deliver the genomic assurance your therapy demands.

Common Sample Types

We work with the full spectrum of materials used in cell and gene therapy research and manufacturing, including:

AAV, lentiviral, or retroviral vectors — for vector identity and packaging confirmation
Transduced cells (CAR-T, TCR-T, NK cells) — for integration site mapping and expression profiling
Genome-edited cell lines (CRISPR/Cas9, TALEN) — for on-/off-target edit validation
Plasmid DNA and production intermediates — for vector quality control
Peripheral blood or bone marrow samples — for monitoring persistence and biodistribution
Organoids, stem cells, and iPSC-derived lines — for functional and differentiation studies

Tailored Solutions

We support every stage of therapeutic development—from discovery to validation to clinical readiness.

Vector Characterization: Full-length sequencing of AAV, lentiviral, and plasmid constructs for QC and regulatory documentation.
Gene Editing Analysis: Precise detection of insertions, deletions, and off-target edits using deep sequencing and bioinformatics pipelines.
Integration Site Mapping: Comprehensive genome-wide mapping of viral vector insertion sites for safety and clonal stability.
Cell Therapy Profiling: TCR/BCR repertoire and single-cell RNA-seq for CAR-T, TCR-T, or NK-cell characterization.
Functional Genomics: Assessing transcriptional activity, transgene expression, and epigenetic impacts post-editing.
Quality & Release Testing: Confirming vector identity, potency, and purity for manufacturing and clinical submission.

Explore our key sequencing services for Cell & Gene Therapy research:

Whole Genome Sequencing (WGS) · Targeted Amplicon Sequencing · RNA Sequencing · Single-Cell RNA-seq · Vector Integration Site Analysis · CRISPR Off-Target Detection