The number of viral vector-based gene therapies in clinical trials has recently grown into the thousands due to the tremendous genetic disease-curing potential they harbor. Yet the comprehensive characterization of critical quality attributes for the safety and efficacy of the material produced for these trials remains a challenge for both manufacturers and regulatory bodies alike.
The demands on analytical development teams are oversized compared to legacy biopharmaceuticals and require a unique focus to address issues such as identification, characterization and enumeration of undesired by-products. Application of established regulatory guidance such as limits to residual host cell DNA requires additional scrutiny due to potential encapsidation and oncogenic potential.
Watch this webinar to discover:
- An overview of common analytical assays employed in development and production of viral vector-based gene therapies
- A review of regulatory guidance and concern around the safety of manufacturing impurities and by-products of common production systems
- Detailed data on the implementation of robust, highly sensitive methods for residual DNA quantitation for both host cell and vector DNA in HEK293 and Sf9 systems
- Introduction to a complete sample-to-results qPCR-based solution to simplify DNA fragment size testing targeting the E1a oncogene in HEK293 based production systems