Simplifying analytical development of viral vector production: robust and sensitive methods for common expression systems
Cell & Gene Therapy Insights 2022; 8(4), 707–718
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. Despite this growth, 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 byproducts. Application of established regulatory guidance, such as limits to residual host cell DNA, requires additional scrutiny due to possible encapsidation and oncogenic potential. This article will focus on the current state of analytical methods in gene therapy workflows, and how leveraging the work Thermo Fisher Scientific has developed can help simplify the burden on analytical development teams.