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 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...
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...