News
Your source for the latest updates, breakthroughs, and insights in drug development and manufacturing. Explore our featured stories, press releases, and event announcements to stay informed about our innovations and contributions to drug development and manufacturing advancements.
News
Your source for the latest updates, breakthroughs, and insights in drug development and manufacturing. Explore our featured stories, press releases, and event announcements to stay informed about our innovations and contributions to drug development and manufacturing advancements.
FDA Issues Draft Guidance on Genome Editing Safety Assessment Using NGS
The FDA’s new draft guidance on genome editing safety marks a significant step toward more standardized, data-driven evaluation of gene therapies.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.
Meet Avance Biosciences at WRIB 2026 in Dallas
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..[...]
Avance Biosciences to Exhibit at the World Vaccine Congress 2026
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 Festival of Biologics USA 2026
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[...]
FDA Increases Flexibility on CMC Requirements for Cell and Gene Therapies to Advance Innovation
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.
How Consistent Assay Performance Reduces Batch Failures
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...
