eBook: Gene therapy analytical testing


Download peer-reviewed content and expert insights in our latest eBook.

To conclude our Spotlight on gene therapy analytical testing, this eBook will revisit some of our highlights from the feature and explore the necessary quality standards, strategies and resources available to improve the standardization of plasmid DNA as a starting material in advanced therapies, particularly in the development of gene therapies and adeno-associated virus-based gene therapies.

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Contents:

  • [FOREWORD] Welcome to our Spotlight eBook on gene therapy analytical testing
  • [INTERVIEW] The roles, rising demand and purification optimization of plasmid DNA
  • [INFOGRAPHIC] Addressing quality standards of plasmid DNA
  • [ANALYTICAL GUIDE] Gene therapy analytical guide
  • [PERSPECTIVE] Bioanalysis of adeno-associated virus gene therapy therapeutics: regulatory expectations
  • [REVIEW] Complexity and diversity of bioanalytical support for gene therapy modalities
  • [RESEARCH ARTICLE] Characterization and quantification of adeno-associated virus capsid-loading states by multi-wavelength analytical ultracentrifugation with ultrascan
  • [EDITORIAL] Addressing high dose AAV toxicity – ‘one and done’ or ‘slower and lower’?
This resource is part of the RegMedNet Spotlight on gene therapy analytical testing. Click here to view the full feature and discover expert insights on this >>>

In association with US Pharmacopeia