Overcoming challenges in gene therapy analytics

The range of available AAV serotypes with differing tropisms offers the potential for precisely targeted in vivo gene delivery. However, to sustain a healthy rate of growth of the AAV platform, robust, GMP-compliant analytical methods and characterization protocols are a necessity, with a key critical quality attribute being empty/full capsid ratio identification. In this article, based on a webinar symposium, various methods available for AAV vector characterization are explored. These include several methods commonly used in empty/full AAV particle characterization and an assessment of recombinant AAV (rAAV) purity characterization via capillary electrophoresis sodium dodecyl sulfate (CE-SDS).

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