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NGS Center of Excellence

20 10, 2025

Technote: Implementing Data Integrity and 21 CFR Part 11 Compliance in NGS Workflows

2026-04-22T18:04:20+00:00

Next-generation sequencing (NGS) technologies are transforming regulated drug development by enabling high-resolution analysis for applications such as gene editing, adventitious agent detection, and sequence confirmation. However, integrating NGS into GMP and GLP workflows introduces significant challenges related to data integrity and compliance with 21 CFR Part 11. These regulations require strict controls over electronic records...

Technote: Implementing Data Integrity and 21 CFR Part 11 Compliance in NGS Workflows2026-04-22T18:04:20+00:00
20 10, 2025

Technote: GUIDE-Seq/iGuide for CRISPR On/Off Target Analysis

2026-04-22T18:04:20+00:00

This guide provides an in-depth look at GUIDE-Seq/iGuide, a key technique for assessing CRISPR-Cas9 on- and off-target effects in gene and cell therapy development. It explains how the method informs the selection of gRNAs, nucleases, and CRISPR conditions to maximize specificity and safety. Readers will also gain insights into the full workflow, from Cas9 cleavage to NGS analysis, supported by Avance Biosciences’ expertise as a licensed GUIDE-Seq service provider...

Technote: GUIDE-Seq/iGuide for CRISPR On/Off Target Analysis2026-04-22T18:04:20+00:00
20 10, 2025

Technote: NGS for Biologics Development Support

2026-04-22T18:04:21+00:00

Explore the power of Next Generation Sequencing (NGS) for biologics development support with our latest whitepaper. Avance Biosciences is at the forefront of NGS testing, offering tailored solutions to support drug development initiatives and GMP manufacturing activities. Delve into real-world case studies, including CRISPR indel amplicon sequencing and insertion site studies, showcasing our expertise in assay development and validation...

Technote: NGS for Biologics Development Support2026-04-22T18:04:21+00:00
17 10, 2025

Poster Presentation: Digitally Secure Sequencing – Implementing Part 11 Ready NGS Data Security in a CRO Environment

2026-04-22T18:04:19+00:00

Next- and third-generation sequencing are vital for GMP, GLP, and clinical applications, but data integrity challenges and 21 CFR Part 11 compliance require secure instruments, validated workflows, and robust audit trails...

Poster Presentation: Digitally Secure Sequencing – Implementing Part 11 Ready NGS Data Security in a CRO Environment2026-04-22T18:04:19+00:00
17 10, 2025

Poster Presentation: Genome-wide Mapping of CRISPR-Cas Off-Target Cleavage Sites via GUIDE-Seq

2026-04-22T18:04:29+00:00

Genome editing offers unprecedented precision, but off-target effects remain a key safety concern. GUIDE-Seq provides a high-throughput, genome-wide method to map CRISPR-Cas activity in living cells, enabling researchers to assess specificity and ensure safer gene-editing therapies...

Poster Presentation: Genome-wide Mapping of CRISPR-Cas Off-Target Cleavage Sites via GUIDE-Seq2026-04-22T18:04:29+00:00
5 08, 2025

Case Study: Quantifying In Vivo Gene Editing in Preclinical Tissues via NGS Amplicon-Seq

2026-04-22T18:04:18+00:00

To support IND-enabling studies, a biotech company needed precise measurement of in vivo gene-editing efficiency in preclinical rat tissues. Avance Biosciences delivered a fully validated NGS amplicon sequencing assay capable of detecting edits as low as 1%, enabling accurate quantification across multiple tissues and guiding data-driven development decisions.

Case Study: Quantifying In Vivo Gene Editing in Preclinical Tissues via NGS Amplicon-Seq2026-04-22T18:04:18+00:00
5 08, 2025

Case Study: Ensuring Plasmid Sequence Fidelity and Purity by NGS for IND-Enabling Drug Substance Release

2026-04-22T18:04:14+00:00

When a gene therapy company needed to verify plasmid identity, purity, and integrity for an IND submission, Avance Biosciences delivered a validated NGS-based solution. The assay enabled low-level variant detection and trace contaminant analysis, supporting FDA compliance and lot release.

Case Study: Ensuring Plasmid Sequence Fidelity and Purity by NGS for IND-Enabling Drug Substance Release2026-04-22T18:04:14+00:00

ABOUT US

Avance Biosciences is a leading Contract Research Organization (CRO) and Contract Testing Organization (CTO) providing CGMP and GLP-compliant analytical and bioanalytical services to support drug development. From early discovery through clinical development and commercialization, we provide CGMP and GLP-compliant services tailored to your therapeutic modality and regulatory needs.

NEWSLETTER SIGNUP

21 CFR Part 11 Compliant
FDA Inspected
CLIA Registered

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  • 5500 NW Central Dr, Houston TX 77092

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