Immunogenicity References
Explore our curated repository of peer-reviewed publications on immunogenicity testing in drug development. Access the latest research and insights on detecting and managing immune responses to biologics, vaccines, and novel therapeutics.
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 [...]
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[...]
The FDA’s new draft guidance on genome editing safety marks a significant step toward more standardized, data-driven evaluation of gene therapies.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.
This case study explores a dual-platform potency assay strategy for multivalent LNP-mRNA vaccines, combining ELISA and flow cytometry to assess both mRNA expression and delivery performance. It highlights key analytical challenges and provides practical insights to support robust, scalable, and regulatory-ready potency testing.
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 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 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[...]
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.
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...
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...
