NGS Center of Excellence Archives

20 10, 2025

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

webmaster2025-10-22T20:49:37+00:00

Download our whitepaper on “Phage Testing of Bacterial Cultures” to understand the critical importance of mitigating phage contamination in biotech and pharmaceutical industries. Learn about the lytic and lysogenic life cycles of phages, their role in bacterial biology, and the challenges they pose to the biotech and pharmaceutical industries due to contamination. Phage presence in cultures can significantly skew results, posing challenges in bacterial identification and isolation...

Technote: Implementing Data Integrity and 21 CFR Part 11 Compliance in NGS Workflowswebmaster2025-10-22T20:49:37+00:00

20 10, 2025

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

webmaster2025-10-22T20:49:56+00:00

Download our whitepaper on “Phage Testing of Bacterial Cultures” to understand the critical importance of mitigating phage contamination in biotech and pharmaceutical industries. Learn about the lytic and lysogenic life cycles of phages, their role in bacterial biology, and the challenges they pose to the biotech and pharmaceutical industries due to contamination. Phage presence in cultures can significantly skew results, posing challenges in bacterial identification and isolation...

Technote: GUIDE-Seq/iGuide for CRISPR On/Off Target Analysiswebmaster2025-10-22T20:49:56+00:00

20 10, 2025

Technote: NGS for Biologics Development Support

webmaster2025-10-22T20:50:04+00:00

Download our whitepaper on “Phage Testing of Bacterial Cultures” to understand the critical importance of mitigating phage contamination in biotech and pharmaceutical industries. Learn about the lytic and lysogenic life cycles of phages, their role in bacterial biology, and the challenges they pose to the biotech and pharmaceutical industries due to contamination. Phage presence in cultures can significantly skew results, posing challenges in bacterial identification and isolation...

Technote: NGS for Biologics Development Supportwebmaster2025-10-22T20:50:04+00:00

17 10, 2025

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

webmaster2025-10-22T20:50:56+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 Environmentwebmaster2025-10-22T20:50:56+00:00

17 10, 2025

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

webmaster2025-10-22T20:51:05+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-Seqwebmaster2025-10-22T20:51:05+00:00

5 08, 2025

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

webmaster2025-10-22T20:51:20+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-Seqwebmaster2025-10-22T20:51:20+00:00

5 08, 2025

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

webmaster2025-10-22T20:51:27+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 Releasewebmaster2025-10-22T20:51:27+00:00

FDA Issues Three New Draft Guidances to Streamline Cell and Gene Therapy Development

World ADC Conference – 2025

New Technote Available – Clarifying Suitability Testing in Regulated Assays

AAPS PharmSci 360 Meeting – 2025

Sept 15-18 – BioProcess International – 2025

Avance Biosciences NGS Center of Excellence: Comprehensive Sequencing Solutions for Biologics, Gene, and Cell Therapy Development