Simplifying analytical development for viral vector production: robust and sensitive methods for common expression systems

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.

In this webinar, an overview of common analytical tests and regulatory expectations for viral vector production, current challenges, and established methods for common production systems will be presented. Methods discussed have been designed to meet regulatory expectations to help simplify your analytical development and quality control strategies.

• 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 byproducts of common production systems
• Detailed data on 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

Sponsored by Thermo Fisher Scientific

Srinath Kashi Ranganath

Staff Scientist, Field Applications, Pharma Analytics Group at Thermo Fisher Scientific

Srinath is a Staff Scientist – Field Applications with Thermo Fisher Scientific, supporting customers in implementing, optimizing and validating the Pharma Analytics workflows for biomanufacturing processes across various therapeutic modalities. Prior, Srinath served as a Bioassay Scientist and subject matter expert for the development and optimization of assays for residual DNA and other process impurities for 6 years. Srinath has an MS in Pharmaceutical Sciences from Campbell University, NC. His thesis was focused on understanding the expression profile of certain intracellular signaling molecules and how altering their function affects the downstream cell signaling.

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SPEAKERS

Srinath Kashi Ranganath

Staff Scientist, Field Applications, Pharma Analytics Group at Thermo Fisher Scientific

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