Integration Site Analysis
Precisely map viral vector integration sites with advanced NGS-based analysis to ensure safe and effective gene and cell therapies.
Optimize vector design and delivery using powerful techniques like LM-PCR, Target Enrichment, and WGS for regulatory-ready data.
To meet stringent regulatory expectations for gene and cell therapies, developers must proactively assess vector integration sites to ensure genomic stability and minimize the risk of insertional mutagenesis. Regulatory agencies require comprehensive integration site analysis to confirm that therapeutic genes are inserted in a controlled, predictable manner. This rigorous evaluation safeguards patient safety, supports long-term efficacy, and is essential for advancing therapies through clinical development and regulatory approval.
Our Expertise
Biotinylated LM-PCR by NGS: Fragmented genomic DNA is adapter-ligated with UMIs, and biotinylated primers targeting vector–genome junctions enable selective enrichment before sequencing. It provides high-sensitivity integration site localization and quantitative frequency assessment for gene and cell therapy applications.
Target Sequencing by Hybridization: Genomic DNA is fragmented and enriched using hybridization probes specific to vector or transgene sequences prior to NGS. This method sensitively detects integration junctions across diverse constructs without relying on LTR-based assumptions.
EPTS (Extension Primer Tag Selection) with NGS: A transgene-specific primer performs linear extension to incorporate a capture tag, enabling magnetic enrichment before sequencing. This targeted linear amplification approach offers high specificity for well-defined integration constructs.
WGS (Whole Genome Sequencing): Genomic DNA is sequenced without enrichment using short- or long-read platforms, and integration sites are identified computationally through split reads and structural variant analysis. This provides an unbiased, genome-wide view of integration events.
Partnering for Regulatory Success
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As your partner in drug development, Avance Biosciences delivers regulatory-ready data backed by validated NGS platforms and expert bioinformatics. Our services are fully integrated with GLP and GMP standards, ensuring precise mapping, reproducible results, and complete data traceability to support your IND, BLA, or other global regulatory submissions with confidence.
Our Customers Say…
Your team met the timelines we needed and did exceptional technical work. I will definitely make my management aware that Avance is a very capable partner for our bioanalytical needs.
Bioanalytical Senior Project Manager, California
Avance Biosciences™ (AB) has delivered the Sequencing data in a record time. Very impressive! We have benefited from AB’s hard work and are very grateful for that. AB team should feel proud of themselves. We thank AB team for their support and contributions, much appreciated.Head of Quality Control, Microbial Manufacturing Service, California
My experience with Avance has been nothing but positive… I will keep sending work your way as I appreciate the attention your team provides and Avance’s creative technical team. See you soon.Director Individualized Medicines, California
Avance has been the ideal partner in helping Mission Bio and our client,… be the first in the world to GMP qualify our single cell % transduction assay for a lentiviral gene therapy product. Excellent execution on the part of the Avance team. We look forward to more collaborations in the future.
Senior Director, Cell & Gene Therapy Business, California
From the preliminary conclusion of this work, we are already pleased to thank you for your customer-oriented approach and proactive communication in the course of this study. We are happy to see the profound difference in business mindset between your organization and our previous vendor…
Project Manager, Belgium
Thank you so much for successfully completing this important project for us on time. We are very satisfied with the final report and thank you for taking the extra effort to customize the report format. We will definitely use your lab for future projects.
Program Manager, California
It has been a pleasure working with you and your team. The project was carried out to the highest standard and delivered in a timely manner. I will definitely recommend Avance Biosciences™’ services to colleagues and friends.
Senior Scientist, Singapore
