Next Generation DNA Sequencing Services
The US FDA recognizes the significant potential of next-generation sequencing (NGS) in drug development and manufacturing. As a transformative tool, NGS is increasingly applied across various phases of drug, biologics, and cell and gene therapy development. It offers unparalleled capabilities in genomic profiling, personalized medicine, biomarker discovery, therapy characterization, and GMP-compliant drug substance and product release testing. This comprehensive utility underscores NGS’s critical role in advancing precision medicine and enhancing the overall efficacy and safety of new therapies. At Avance Biosciences, we offer comprehensive CGMP/GLP-compliant NGS lab services designed to support your projects at every stage, from early research through clinical trials and quality control.
Our Expertise
Avance Biosciences is one of the earliest adopters of next-generation sequencing (NGS) in GMP- and GLP-compliant laboratories. We introduced the Illumina MiSeq to our GMP lab in 2013 and have since completed numerous method development, validation, and testing projects under rigorous regulatory standards. Building on this legacy, we now offer CGMP/GLP-compliant services using the Element AVITI System, an advanced NGS platform that combines high accuracy, low duplication rates, and reduced index hopping with improved cost-efficiency. These NGS platforms are ideal for applications such as biomarker discovery, gene expression profiling, variant detection, and microbial genomic analysis. With deep expertise in short-read NGS methodology and innovative approaches to FDA 21 CFR Part 11 compliance, Avance Biosciences continues to lead in the regulated application of NGS technology.
Selected NGS Services
Application
Description
Identity Testing by NGS
The sequencing library is prepared using various library preparation methods, followed by paired-end sequencing on either the MiSeq or AVITI instrument. This approach allows for sequence confirmation of plasmid, viral vectors, sgRNA, mRNA, and phage.
RNA-Seq for CHO Clone Selection
RNA-seq is used for CHO (Chinese Hamster Ovary) clone selection, offering several benefits and providing comprehensive insights into the cellular and molecular characteristics of different clones.
Amplicon Sequencing
NGS amplicon sequencing is essential for gene editing, enabling precise on- and off-target analysis and characterization of indels and mutations. It provides high-resolution data on specific DNA regions, ensuring the accuracy and efficiency of tools like CRISPR, prime editing, and zinc-finger nucleases.
On/Off Targets Analysis
GuideSeq, rhAmpSeq, and other custom NGS methods are implemented to assess potential off-targets of gene editing products, including CRISPR-Cas9, Zinc Finger Nucleases, and other gene editing technologies. These advanced techniques ensure precise and comprehensive evaluation of gene editing specificity and safety
Gene Translocation Analysis
Amplicon sequencing results from rhAmpSeq are analyzed to identify potential gene translocation events, providing more in-depth information compared to ddPCR or qPCR-based methods. This advanced analysis offers enhanced sensitivity and specificity, allowing for thorough assessment of genetic alterations and translocations.
Integration Site Analysis
Various methods have been developed to investigate integration sites, including whole-genome sequencing (WGS), linear amplification sequencing, and hybridization-based target sequencing. These techniques are instrumental in elucidating integration sites in CHO clonal cell banks, lentivirus-modified CAR-T cells, and identifying potential integration events in animal and human studies.
Targeted Adventitious Agents Testing
This test is designed to detect a specific, known set of adventitious contaminants. It focuses on a predetermined list of potential pathogen threats and uses targeted sequencing or specific assays to identify these known viruses.
Broad-Spectrum Adventitious Agents Testing
This test aims to detect a wide range of potential viral or bacterial contaminants. It does not rely on prior knowledge of the contaminants and can identify unexpected or novel pathogens by sequencing all genetic material (DNA and RNA) present in the sample.
Gene Editing Preclinical PK Study
NGS amplicon sequencing assays are designed and validated to determine the durability and persistence of gene editing effects in animal biodistribution studies.
Gene Editing Preclinical Progeny Study
NGS amplicon sequencing assays are designed and validated to determine durability and persistence in different generations of animals for progeny study.
Gene Editing Clinical PK Study
NGS amplicon sequencing assays are designed and validated to determine the durability and persistence of gene editing effects in human pharmacokinetics (PK) studies.
Custom Workflows
Custom NGS workflows are developed to meet unique project needs, integrating specialized library prep, sequencing platforms, and bioinformatics pipelines. Ideal for novel assay development, rare variant detection, or unconventional sample types requiring tailored solutions.