News

12 08, 2026

Bioprocess and Cell & Gene Therapy International 2026

2026-08-12T15:37:22+00:00

Avance Biosciences will exhibit at BioProcess International and Cell & Gene Therapy International 2026, highlighting analytical support for mRNA therapeutics and RNA vaccines, on/off-target analysis, biodistribution analysis, whole genome sequencing, and potency testing. Visit our team at Booth #1402 to discuss analytical strategies for advancing biologics and next-generation therapies...

Bioprocess and Cell & Gene Therapy International 20262026-08-12T15:37:22+00:00
23 07, 2026

New FDA Guidance Documents Resource Available

2026-07-23T13:47:35+00:00

Keeping up with new FDA guidance documents can be challenging. The FDA regularly publishes new draft and final guidance covering topics ranging from drug development and manufacturing to diagnostics, biologics, cell and gene therapy, medical devices, and regulatory policy...

New FDA Guidance Documents Resource Available2026-07-23T13:47:35+00:00
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FDA Issues Draft Guidance on Genome Editing Safety Assessment Using NGS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The FDA’s new draft guidance on genome editing safety marks a significant step toward more standardized, data-driven evaluation of gene therapies.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
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