Gene & Cell Therapy Safety

Insertion Site
Analysis
Core

End-to-End Vector Safety Assessment
Retroviral & Lentiviral ISA
NEW AAV ISA & Episome/Insertion Ratio

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

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

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 & AAV ISA
Comprehensive integration site analysis for retroviral and lentiviral vectors across all major therapeutic modalities — now extended to AAV vectors with episome/insertion ratio estimation.
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.
Services

What we analyse

Our integration site analysis services are organised around two vector platforms — retroviral & lentiviral vectors for ex vivo and in vivo applications, and AAV vectors for in vivo gene delivery.

Platform 01
Retroviral & Lentiviral Vector ISA
Comprehensive integration site analysis for retroviral and lentiviral vectors across gene and cell therapy programs.
01
Ex Vivo · In Vivo
Gene Therapies
Integration site analysis for ex vivo and in vivo gene therapy programs — tracking integration profiles in haematopoietic stem cells, progenitor populations, and target tissues across preclinical and clinical settings.
02
Ex Vivo · In Vivo
CAR-T & Engineered Cell Therapies
Integration site profiling and clonal monitoring for ex vivo and in vivo CAR-T and engineered cell therapies — supporting safety assessment, clonal dynamics tracking, and manufacturing quality control.
Platform 02 · New
AAV Integration Site Analysis
Integration site analysis for adeno-associated virus (AAV) vectors in in vivo gene delivery programs, including episome/insertion ratio estimation.
New
03
In Vivo · AAV
In Vivo Gene Delivery
Precise mapping of rare AAV genomic insertion events across target tissues — brain, liver, muscle, and beyond. Includes episome/insertion ratio estimation, a critical metric for understanding vector persistence, genotoxicity risk, and long-term safety in preclinical and clinical AAV programs.
Workflow

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.
Deliverables

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.
Our Team

The people
behind the science

A multidisciplinary team spanning UCL and Great Ormond Street Hospital, bringing together scientific leadership, technical expertise, and clinical operations.

Luca Biasco
Scientific Director
Luca Biasco
UCL
Elena Alvarez Mediavilla
Technical Operations
Elena Alvarez Mediavilla
UCL · GOSH
Kimberly Gilmour
Logistics & Finance
Kimberly Gilmour
GOSH
Caterina Pelosi
Intern
Caterina Pelosi
ISA Core
Publications

Recent publications
featuring our pipeline

Selected peer-reviewed work from our group leveraging ISA methodology and the IS-Seq bioinformatics pipeline.

Cell
2026
Distinct in vivo dynamics of donor-derived stem cell memory CAR T cells post-allogeneic HSCT relapse.
Gattinoni L, Inchingolo G, Harrer DC, Susana A, Puccio S, Slavkovic-Lukic D, Natrakul DA, Strieder N, Heuser-Loy C, Baldwin JG, Fioravanti J, Ji Y, Gautam S, Suriano C, Martín-Santos A, Schelker RC, Patel N, Mann J, Goff S, Mikkilineni L, Yang JC, Kwong MLM, Patel R, Rehli M, Highfill SL, Stroncek DF, Rosenberg SA, Biasco L, Lugli E, Brudno JN, Kochenderfer JN.
doi: 10.1016/j.cell.2026.03.047
Nature Biotechnology
2025
In vivo gene editing of human hematopoietic stem and progenitor cells using envelope-engineered virus-like particles.
Botchkarev VV Jr, Harrington S, Stoppato M, Justen A, Kimber C, Kapuria A, Gibson KM, Chu CS, Xu Y, Haugh K, Ankala R, Kipniss N, DeGroot A, Moore E, de Jesus R, Adewale F, Daniels K, Crocker S, Liang A, Joyce S, Roberto N, Angel P, Smith D, Wong A, Adler N, Berlfein V, Amatya S, Cruite P, Usmani S, Ruzo A, Ferland B, Chandra S, Rebar EJ, Shah JV, Trudeau K, Biasco L.
doi: 10.1038/s41587-025-02915-2
BMC Bioinformatics
2023
IS-Seq: a bioinformatics pipeline for integration sites analysis with comprehensive abundance quantification methods.
Yan A, Baricordi C, Nguyen Q, Barbarossa L, Loperfido M, Biasco L.
doi: 10.1186/s12859-023-05390-1
Nature Cancer
2021
Clonal expansion of T memory stem cells determines early anti-leukemic responses and long-term CAR T cell persistence in patients.
Biasco L, Izotova N, Rivat C, Ghorashian S, Richardson R, Guvenel A, Hough R, Wynn R, Popova B, Lopes A, Pule M, Thrasher AJ, Amrolia PJ.
doi: 10.1038/s43018-021-00207-7
Nature Communications
2021
Long-term lymphoid progenitors independently sustain naïve T and NK cell production in humans.
Izotova N, Rivat C, Baricordi C, Blanco E, Pellin D, Watt E, Gkazi AS, Adams S, Gilmour K, Bayford J, Booth C, Gaspar HB, Thrasher AJ, Biasco L.
doi: 10.1038/s41467-021-21834-9
Strategic partners for
Academic Groups
Biotech Companies
Clinical Teams
Regulatory Programs
IND-Enabling Studies
Long-Term Follow-Up
Get In Touch

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