In this perspective article, published by Bioanalysis, the authors present the current regulatory recommendations for bioanalytical support of adeno-associated virus-based gene therapy development.
Browsing: gene therapy
Gene therapy is an experimental technique that involves the delivery of therapeutic nucleic acid polymers into a patient’s cells to treat or prevent a disease.
In this podcast, we talk to Vibhor Gupta (Absorption Systems; PA, USA) about the importance of robust, reliable and accurate potency assays for cell and gene therapy products.
In this feature we explore how the adeno-associated virus has reinvigorated the field of gene therapy. We also explore the challenges developing gene therapies and the requirement for multi-tiered analysis approaches when assessing patient responses.
Researchers from Dyno Therapeutics (MA, USA) and Harvard University (MA, USA) have reported a comprehensive machine-guided approach to produce improved adeno-associated virus capsids for gene therapy delivery.
This In the Zone infographic explores the tools and techniques used during the AAV gene therapy development pathway, detailing processes from rAAV generation and in vitro and in vivo testing through to assessing the host immune response.
Find out what regulatory recommendations exist for bioanalytical support of adeno-associated virus gene therapy development in this Bioanalysis article giving an overview of the current regulatory recommendations as found in FDA and EMA guidance documents.
As part of our mini-Spotlight on cell and gene therapies, we carried out a survey to gain an insight into the trends, challenges and developments associated with these fields – find out the results in this informative infographic.
Arno Kromminga and Lydia Michaut will discuss the strategies and challenges of immunogenicity assessment for gene therapy compounds.