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20 05, 2026

GUIDE-seq and NGS-based off-target analysis support genome editing safety assessment for engineered Treg therapy

2026-05-20T20:33:05+00:00

GentiBio recently presented genome editing safety data during the “On- and Off-Target Method Development” session st the 2026 ASGCT Meeting, highlighting the extensive off-target characterization strategy used to support development of GNTI-122, an engineered regulatory T cell (Treg) therapy for type 1 diabetes (T1D). The presentation is particularly timely given the recent FDA [...]

GUIDE-seq and NGS-based off-target analysis support genome editing safety assessment for engineered Treg therapy2026-05-20T20:33:05+00:00
29 04, 2026

Avance Biosciences to Exhibit at the ASGCT 2026 Annual Meeting

2026-04-29T14:25:40+00:00

Avance Biosciences will be exhibiting at the ASGCT Annual Meeting in Boston, May 11–15, 2026. Visit Booth #1062 to connect with our team and learn how our bioanalytical and CMC testing services support cell and gene therapy development[...]

Avance Biosciences to Exhibit at the ASGCT 2026 Annual Meeting2026-04-29T14:25:40+00:00
16 04, 2026

FDA Issues Draft Guidance on Genome Editing Safety Assessment Using NGS

2026-06-24T13:50:08+00:00

The FDA’s new draft guidance on genome editing safety marks a significant step toward more standardized, data-driven evaluation of gene therapies. With next-generation sequencing (NGS) at the core, the guidance outlines clear expectations for assessing off-target effects, genomic integrity, and rare editing events, providing sponsors with a more defined regulatory path for IND and BLA submissions.

FDA Issues Draft Guidance on Genome Editing Safety Assessment Using NGS2026-06-24T13:50:08+00:00
7 04, 2026

Meet Avance Biosciences at WRIB 2026 in Dallas

2026-04-22T18:03:42+00:00

Avance Biosciences is pleased to announce that we will be exhibiting at the 20th WRIB (Workshops on Recent Issues in Bioanalysis), taking place April 13–17, 2026, in Dallas, Texas. This premier industry event brings together leading scientists, regulators, and bioanalytical experts from across the global pharmaceutical and biotechnology community to discuss the latest advancements, challenges, and regulatory expectations in bioanalysis..[...]

Meet Avance Biosciences at WRIB 2026 in Dallas2026-04-22T18:03:42+00:00
11 03, 2026

Avance Biosciences to Exhibit at the World Vaccine Congress 2026

2026-04-22T18:03:41+00:00

Avance Biosciences will be exhibiting at the World Vaccine Congress in Washington, DC, where we will highlight our analytical testing services that support vaccine development programs. Our team provides potency assay development, next-generation sequencing, and cell-based assays designed to help advance RNA therapeutics and mRNA vaccine candidates from research through regulatory submission.[...]

Avance Biosciences to Exhibit at the World Vaccine Congress 20262026-04-22T18:03:41+00:00
20 01, 2026

Avance Biosciences to Exhibit at Festival of Biologics USA 2026

2026-04-22T18:03:40+00:00

Avance Biosciences will be exhibiting at Festival of Biologics USA 2026 in San Diego. Visit us at Booth #322 to learn how our CGMP-, GLP-, and CLIA-compliant bioanalytical services support biologics development, from assay development and validation to potency, immunogenicity, and advanced analytical testing[...]

Avance Biosciences to Exhibit at Festival of Biologics USA 20262026-04-22T18:03:40+00:00
13 01, 2026

FDA Increases Flexibility on CMC Requirements for Cell and Gene Therapies to Advance Innovation

2026-04-22T18:03:44+00:00

The FDA is clarifying its flexible approach to chemistry, manufacturing, and control (CMC) requirements for cell and gene therapies, helping sponsors accelerate development and prepare for Biologics License Applications while maintaining rigorous standards for safety, quality, purity, and potency.

FDA Increases Flexibility on CMC Requirements for Cell and Gene Therapies to Advance Innovation2026-04-22T18:03:44+00:00
6 01, 2026

How Consistent Assay Performance Reduces Batch Failures

2026-04-22T18:04:12+00:00

Inconsistent assay performance is a common but often overlooked cause of batch failures. Robust, reproducible analytical and bioanalytical assays help reduce risk, improve decision-making, and support reliable batch release across drug development and manufacturing...

How Consistent Assay Performance Reduces Batch Failures2026-04-22T18:04:12+00:00
30 12, 2025

What PERT Signals About the Future of Gene Editing Manufacturing and Regulation

2026-04-22T18:04:25+00:00

A new prime editing strategy, PERT, enables disease-agnostic treatment of nonsense mutations by permanently converting an endogenous tRNA into a suppressor tRNA, with major implications for scalable gene-editing manufacturing and regulation...

What PERT Signals About the Future of Gene Editing Manufacturing and Regulation2026-04-22T18:04:25+00:00
23 12, 2025

What “Fit-for-Purpose” Really Means in Bioanalytical Method Development

2026-04-22T18:04:36+00:00

Fit-for-purpose bioanalytical methods align assay performance with development stage and risk, ensuring data are reliable, efficient, and defensible while supporting critical scientific, regulatory, and CMC decisions across modern drug development programs...

What “Fit-for-Purpose” Really Means in Bioanalytical Method Development2026-04-22T18:04:36+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.

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