The therapeutic potential of viral vector-based gene therapies is tremendous, but with some recently adverse outcomes in clinical trials, the safety of these drugs has come into question. Both regulatory agencies and manufacturers are working hard to define appropriate critical quality attributes and identify process-related impurities crucial to ensuring patient safety.
These requirements increase the demand of analytical development teams working on viral vectors, over traditional biopharmaceuticals, to utilize novel methods to measure unique properties.
Analytics of standard byproducts such as residual host cell DNA are no longer simply routine, and require closer scrutiny including highly sensitive and robust fragment sizing and oncogenetic sequence quantification.
This webinar will discuss an overview of analytic tests required for viral vector manufacturing, current and evolving regulatory guidance, and methods that can be adopted to simplify analytical development to quantify and size residual DNA and oncogenetic impurities. Data included will demonstrate the method’s design to meet regulatory expectations for residual DNA quantification, fragment sizing, and E1a oncogene quantification.
- An overview of common analytical assays employed in development and production of viral vector-based gene therapies.
- A review of pertinent analytical regulatory guidance as well as recent FDA concerns for viral vector-based therapies.
- Performance data of robust, highly sensitive methods to simplify analytical development of residual DNA quantitation for both host cell and vector DNA, as well as DNA fragment size testing targeting the E1a oncogene.
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