NGS Amplicon Sequencing Services
Detect on- and off-target edits with precision using NGS amplicon sequencing, essential for evaluating CRISPR, prime editing, and other gene editing tools.
Ensure the safety and efficacy of gene and cell therapies with accurate indel profiling and mutation detection in targeted DNA regions.
Avance Biosciences added the Illumina MiSeq platform to our GMP services lab in 2013. Since this time, we have successfully completed numerous GMP grade NGS On/Off target analysis in support of our customers edited cell-based drug products. With our unparalleled understanding of Illumina NGS chemistry and our innovative solutions for addressing FDA Part 11 compliance, Avance Biosciences stands as a true leader in the GMP and GLP applications of NGS technology.
Case Studies
In 2013, we implemented a GMP-compliant MiSeq assay to support validation of a companion diagnostic PCR test. To our knowledge, the first GMP use of an NGS instrument.
In 2017, we performed GLP-validated NGS amplicon sequencing for a CRISPR-based cell therapy study, which became the first FDA-approved CRISPR therapy in 2023
Since 2017, we’ve designed FDA-compliant NGS amplicon assays and validated pipelines to support clinical and animal studies with stable, auditable analysis environments.
Since 2019, we’ve developed and validated rhAMPSeq assays to assess gene editing accuracy, indels, and mutation rates for CRISPR, prime editing, and ZFNs.
In 2021, we validated a Mission Bio Tapestri single-cell assay for an HSC therapy, using multiplex amplicon sequencing to assess editing at single-cell resolution.
Improved NGS Amplicon Sequencing with Avance Biosciences as Your Testing Partner
Our team has deep expertise in designing and validating NGS amplicon sequencing assays to support gene and cell therapy programs. We routinely analyze on- and off-target editing, indel formation, and mutation frequency across a wide range of therapeutic platforms. With experience spanning CRISPR, prime editing, and other gene editing tools, we handle complex studies involving large sample volumes with precision and speed. Our validated workflows and contamination controls ensure reliable, high-resolution data that meets stringent regulatory requirements and supports confident decision-making.
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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