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.
Avance Biosciences is proud to participate in Advanced Therapies USA 2025, showcasing our CGMP and GLP-compliant testing services to support the development of next-generation cell and gene therapies.[...]
Avance Biosciences is excited to exhibit at AAPS 2025 PharmSci 360! Discover our CGMP- and GLP-compliant bioanalytical and analytical services supporting next-generation therapies, from RNA and gene/cell therapies to ADCs and exosome-based modalities[...]
Avance Biosciences is proud to participate in the 2025 World ADC Conference, highlighting our CGMP- and GLP-compliant analytical expertise supporting the development of antibody-drug conjugates. From assay development and validation to comprehensive bioanalytical testing, our services empower biopharmaceutical innovators to advance safer, more effective targeted therapies.[...]
