Published on The Associated Press Sarepta has suspended shipments of Elevidys and paused a trial arm after a second non-ambulatory...

Published on Lonza White Paper (CD-DS008) Choosing the right transfection method is key in gene therapy and biomedical research. This...

Published on Lonza White Paper (CT-SP008) Cell therapy manufacturing is often held back by viral vector limitations and labor-intensive...

Published on Cell & Gene The U.S. FDA has approved the first product under its new Advanced Manufacturing Technology (AMT) designation, a...

Published on Cell & Gene As gene therapy evolves, so must the validation strategies behind its assays. This article outlines...

Published on Cell & Gene Global regulatory requirements are evolving fast, especially in cell and gene therapy. This article outlines...

Published on Cell & Gene Speed and transparency in clinical data review are vital for regulatory approval. This article looks at how...

Published on Cell & Gene Cell therapy products often sit in regulatory gray zones due to their complex nature. This article explores how...

Published on Cell & Gene With updates to EU Annex 1, contamination control strategy (CCS) is now a central part of regulatory...

Published on Cell & Gene Extractables and leachables (E&L) testing is a critical regulatory expectation in cell and gene therapy...

Published on Cell & Gene Regeneron has introduced a cGMP-compliant mobile gowning cleanroom built to meet ISO 7 standards. This setup...

Published on Cell & Gene Facility design plays a major role in compliance. This article discusses how modular cleanrooms can help reduce...

Published on Cell & Gene Testing gene therapy products involves unique technical and regulatory hurdles. This article outlines four key...

Published on Cell & Gene At the recent Cell & Gene Tech Expo, Femtobiomed Inc. presented its latest work in cellular immunotherapies with...

Published on Cell & Gene Maintaining cleanroom standards is a key part of regulatory compliance in cell and gene therapy facilities. ...