Gene & Cell Therapy Safety

Insertion Site
Analysis
Core

End-to-End Vector Safety Assessment

High-resolution clonal tracking and vector integration analysis — from preclinical development to clinical monitoring — powered by over two decades of ISA expertise.

IS-4421 IS-1104 IS-8832
20+ Years ISA Expertise
UK First Integrated ISA Core
GMP Clinical-Grade Workflow

Where precision
meets clinical grade

The ISA Core is an end-to-end platform designed to support vector safety assessment and high-resolution clonal tracking across gene and cell therapy programs. Positioned within one of Europe's leading gene therapy clinical centres, we believe this is the first UK-based ISA core offering a fully integrated, clinical-grade workflow.

"Seamlessly operational across preclinical and clinical development pipelines."
Retroviral & Lentiviral ISA
Comprehensive integration site analysis for retroviral and lentiviral vectors across all major therapeutic modalities.
Clinical Centre Embedded
Based within a leading European gene therapy clinical centre, enabling seamless translation from bench to bedside.
Regulatory-Ready
Supporting IND-enabling studies, clinical monitoring, and long-term follow-up with documentation aligned to regulatory needs.
Illumina-Powered Sequencing
State-of-the-art Illumina sequencing combined with robust bioinformatic pipelines for high-resolution output.

What we analyse

Our integration site analysis services span the full spectrum of gene and cell therapy approaches, from ex vivo modification to in vivo delivery.

01
Ex Vivo
Gene Therapies
Comprehensive ISA for ex vivo gene therapy programs — tracking integration profiles in haematopoietic stem cells, progenitor populations, and other engineered cell products.
02
In Vivo
Gene Delivery
In vivo gene delivery approaches including adeno-associated and lentiviral vectors — mapping integration landscapes across target tissues with high sensitivity.
03
Cell Therapy
CAR-T & Engineered Cells
Integration site profiling and clonal monitoring for CAR-T and other engineered cell therapies — supporting both safety assessment and manufacturing quality control.

Streamlined,
high-quality service

Starting from cell pellets or genomic DNA, our end-to-end pipeline integrates optimised sample processing, next-generation sequencing, and validated bioinformatic analysis into a single, cohesive service.

01
Sample Input
Cell pellets or genomic DNA — optimised extraction and quality assessment protocols.
02
Library Prep
Optimised sample processing and integration site enrichment using validated protocols.
03
Illumina Sequencing
High-throughput Illumina sequencing delivering deep, accurate coverage of integration sites.
04
Bioinformatics
Robust, validated pipelines — from alignment to annotation, clonal quantification and reporting.

Outputs built
for decisions

Every deliverable is tailored for meaningful decision-making — whether that's regulatory filing, clinical monitoring, or publication.


We also offer custom analyses aligned with regulatory and translational needs, with experience supporting IND-enabling studies, clinical monitoring, and long-term follow-up programs.

🗺️
Integration Site Mapping
Precise genome-wide mapping of retroviral and lentiviral integration sites at single-site resolution.
🌿
Clonal Diversity & Dominance
Shannon entropy, clonality indices, and dominance metrics to characterise the clonal landscape.
📈
Longitudinal Clonal Tracking
Time-series tracking of clone dynamics — identifying expansion, persistence, or contraction of individual clones.
📊
Publication-Ready Visualizations
Clear, polished figures and reports designed for clinical teams, regulatory dossiers, and peer-reviewed publication.

Strategic partners for
Academic Groups
Biotech Companies
Clinical Teams
Regulatory Programs
IND-Enabling Studies
Long-Term Follow-Up

Let's discuss
your program

Whether you are looking to de-risk vector integration profiles, monitor clonal dynamics, or strengthen your safety package — we would welcome the opportunity to discuss how we can support your program.



🔬
Expertise
Retroviral & Lentiviral Integration Site Analysis
📍
Location
Europe's leading gene therapy clinical centre, United Kingdom
🤝
Partnerships
Academic, Biotech, Clinical & Regulatory programs