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.
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...
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...
The FDA’s new guidance on therapeutic protein biosimilars emphasizes rigorous analytical assessment as the foundation for demonstrating similarity. Developers must focus on physicochemical, functional, and quality attributes to streamline regulatory approval and reduce clinical study requirements.
Avance Biosciences now offers PacBio HiFi long-read sequencing, providing highly accurate, full-length plasmid analysis. This technology ensures precise detection of variants, contaminants, and structural anomalies for reliable plasmid QC...
HOUSTON, December 3, 2025 /PRNewswire/ — Avance Biosciences today announced the opening of its new Potency and Cell-Based Assay Center of Excellence, a purpose-built facility designed to expand and centralize the company's capabilities in potency and functional cell-based assays under GMP compliance [...]
Next-generation sequencing (NGS) outperforms Sanger for cell therapy testing, offering higher sensitivity, full-length vector analysis, and population-level variant detection to ensure genomic integrity, regulatory compliance, and scalable quality control...
Explore the FDA’s new Plausible Mechanism Pathway and how it compares to accelerated approval, expedited programs, and other regulatory routes for rare disease therapies.