From The Stage

Immunogenicity Assessment of Gene Therapy Compounds

Dr. Arno Kromminga
Posted by Dr. Arno Kromminga / / Gene Therapy, Industry Update

By Dr. Arno Kromminga and Dr. Lydia Michaut
Gene therapy has experienced an exciting resurgence in the post-genomic era, but unwanted immunogenicity is still a concern. Our latest blog gives insight into the current concepts for designing an immunogenicity assessment strategy fitting the specific needs of a given gene therapy compound.

The FDA’s Response to an Increase in the Development of Gene and Cell Therapies: What It Means for Sponsors

Jim Datin
Posted by Jim Datin / / Cell Therapy, Gene Therapy, Industry Update

The FDA has observed an unprecedented increase in the number of cell and gene therapy products entering the early stages of development. In a recent statement, the agency outlined new planned policies to help accelerate these innovations through the pipeline to clinical success. We discuss what this announcement means to sponsors.

Assay Design for Immunogenicity Testing: Cell-Based or Ligand Binding?

David Rusnak
Posted by David Rusnak / / Cell-Based Assays, Immunogenicity

Unlike small-molecule drugs, large molecule therapeutics face a high chance of detection by the immune system, and are therefore more apt to trigger alarms. The resulting immune responses can range from largely benign to life-threatening, which is why immunogenicity testing has become a critical requirement in the biologics development process. But, the development and implementation of such assays can be technically challenging, and this is causing differing industry opinions around the use of cell-based functional assays vs. non-cell-based competitive ligand binding assays for NAb detection. The Turning Tide Cell-based assays…

Biomarkers and Immunogenicity in the Spotlight at the 2016 10th Workshop on Recent Issues in Bioanalysis

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Industry Update

The whitepaper based on discussions at the 10th Workshop on Recent Issues in Bioanalysis (WRIB) has been published! Everyone who participated, are very excited to share the knowledge of industry leaders and regulators that was aggregated during the weeklong event. This year’s WRIB was quite a successful event. Close to 700 industry leaders from biopharmaceutical and biotechnology companies, CROs, and regulatory agencies gathered in Orlando, Florida to share, review, and discuss topics in bioanalysis related to PK, biomarkers, and immunogenicity. WRIB is a unique gathering because it is specifically designed…