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What PERT Signals About the Future of Gene Editing Manufacturing and Regulation
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...
What “Fit-for-Purpose” Really Means in Bioanalytical Method Development
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...
New FDA Final Guidance on Development of Therapeutic Protein Biosimilars: Analytical Considerations for Biologics Developers
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.
Why We Brought PacBio HiFi Online at Avance: The Accuracy Needed for Plasmid QC
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...
Avance Biosciences Launches Potency & Cell-Based Assay Center in Houston
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 [...]
Why Cell Therapy Developers Are Moving From Sanger to NGS for Identity & Purity Testing
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...