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.
Sponsored by Thermo Fisher Scientific